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JCI - Safety and implementation of phase 1 randomized GLA-SE-adjuvanted CH505TF gp120 HIV vaccine trial in newborns

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Gray" /> <meta name="citation_journal_title" content="The Journal of Clinical Investigation" /> <meta name="citation_journal_abbrev" content="J Clin Invest" /> <meta name="citation_publisher" content="American Society for Clinical Investigation" /> <meta name="citation_volume" content="" /> <meta name="citation_doi" content="10.1172/JCI186927" /> <meta name="citation_pmid" content="0" /> <meta name="citation_publication_date" content="2025/04/03" /> <meta name="citation_html_url" content="http://www.jci.org/articles/view/186927" /> <meta name="citation_pdf_url" content="http://www.jci.org/articles/view/186927/files/pdf" /> <meta name="citation_xml_url" content="http://www.jci.org/articles/view/186927/xml" /> <meta name="citation_issn" content="0021-9738" /> <meta name="citation_fulltext_world_readable" content="" /> <meta name="DC.Format" content="text/html" /> <meta name="DC.Language" content="en" /> <meta content="Safety and implementation of phase 1 randomized GLA-SE-adjuvanted CH505TF gp120 HIV vaccine trial in newborns" name="DC.Title" /> <meta content="10.1172/JCI186927" name="DC.Identifier" /> <meta content="2025-04-03" name="DC.Date" /> <meta content="American Society for Clinical Investigation" name="DC.Publisher" /> <meta content="Avy Violari" name="DC.Contributor" /> <meta content="Kennedy Otwombe" name="DC.Contributor" /> <meta content="William Hahn" name="DC.Contributor" /> <meta content="Shiyu Chen" name="DC.Contributor" /> <meta content="Deirdre Josipovic" name="DC.Contributor" /> <meta content="Vuyelwa Baba" name="DC.Contributor" /> <meta content="Asimenia Angelidou" name="DC.Contributor" /> <meta content="Kinga K. Smolen" name="DC.Contributor" /> <meta content="Ofer Levy" name="DC.Contributor" /> <meta content="Nonhlanhla N. Mkhize" name="DC.Contributor" /> <meta content="Amanda S. Woodward Davis" name="DC.Contributor" /> <meta content="Troy M. Martin" name="DC.Contributor" /> <meta content="Barton F. Haynes" name="DC.Contributor" /> <meta content="Wilton B. Williams" name="DC.Contributor" /> <meta content="Zachary K. Sagawa" name="DC.Contributor" /> <meta content="James G. Kublin" name="DC.Contributor" /> <meta content="Laura Polakowski" name="DC.Contributor" /> <meta content="Margaret Brewinski Isaacs" name="DC.Contributor" /> <meta content="Catherine Yen" name="DC.Contributor" /> <meta content="Georgia Tomaras" name="DC.Contributor" /> <meta content="Lawrence Corey" name="DC.Contributor" /> <meta content="Holly Janes" name="DC.Contributor" /> <meta content="Glenda E. 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Smolen,<sup>4</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-8"> Ofer Levy,<sup>4</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-9"> Nonhlanhla N. Mkhize,<sup>5</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-10"> Amanda S. Woodward Davis,<sup>2</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-11"> Troy M. Martin,<sup>2</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-12"> Barton F. Haynes,<sup>6</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-13"> Wilton B. Williams,<sup>7</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-14"> Zachary K. Sagawa,<sup>8</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-15"> James G. Kublin,<sup>2</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-16"> Laura Polakowski,<sup>9</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-17"> Margaret Brewinski Isaacs,<sup>9</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-18"> Catherine Yen,<sup>9</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-19"> Georgia Tomaras,<sup>10</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-20"> Lawrence Corey,<sup>2</sup> </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-21"> Holly Janes,<sup>2</sup> and </a> <a class="author-affiliation show-more" href="javascript:void(0);" data-dropdown="author-affiliation-22"> Glenda E. Gray<sup>1</sup> </a> </h4> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-0"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Violari, A. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Avy%22+author.last_name%3A%22Violari%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Violari+A[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AA+Violari%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-1"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Otwombe, K. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Kennedy%22+author.last_name%3A%22Otwombe%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Otwombe+K[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AK+Otwombe%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-2"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Hahn, W. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22William%22+author.last_name%3A%22Hahn%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Hahn+W[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AW+Hahn%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-3"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Chen, S. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Shiyu%22+author.last_name%3A%22Chen%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Chen+S[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AS+Chen%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-4"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Josipovic, D. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Deirdre%22+author.last_name%3A%22Josipovic%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Josipovic+D[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AD+Josipovic%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-5"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Baba, V. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Vuyelwa%22+author.last_name%3A%22Baba%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Baba+V[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AV+Baba%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-6"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Angelidou, A. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Asimenia%22+author.last_name%3A%22Angelidou%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Angelidou+A[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AA+Angelidou%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-7"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Smolen, K. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Kinga K.%22+author.last_name%3A%22Smolen%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Smolen+K[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AK+Smolen%22" >Google Scholar </a> | <a target="_blank" href=https://orcid.org/0000-0001-8650-3693 ><img src="/assets/orcid_24x24-c3dd8466870e6d6844746d0390885a978817f110ed6b16957bc1ad3a282af054.png" /> </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-8"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Levy, O. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Ofer%22+author.last_name%3A%22Levy%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Levy+O[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AO+Levy%22" >Google Scholar </a> | <a target="_blank" href=https://orcid.org/0000-0002-5859-1945 ><img src="/assets/orcid_24x24-c3dd8466870e6d6844746d0390885a978817f110ed6b16957bc1ad3a282af054.png" /> </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-9"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Mkhize, N. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Nonhlanhla N.%22+author.last_name%3A%22Mkhize%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Mkhize+N[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AN+Mkhize%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-10"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Woodward Davis, A. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Amanda S.%22+author.last_name%3A%22Woodward Davis%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Woodward Davis+A[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AA+Woodward Davis%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-11"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Martin, T. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Troy M.%22+author.last_name%3A%22Martin%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Martin+T[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AT+Martin%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-12"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Haynes, B. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Barton F.%22+author.last_name%3A%22Haynes%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Haynes+B[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AB+Haynes%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-13"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Williams, W. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Wilton B.%22+author.last_name%3A%22Williams%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Williams+W[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AW+Williams%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-14"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Sagawa, Z. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Zachary K.%22+author.last_name%3A%22Sagawa%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Sagawa+Z[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AZ+Sagawa%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-15"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Kublin, J. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22James G.%22+author.last_name%3A%22Kublin%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Kublin+J[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AJ+Kublin%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-16"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Polakowski, L. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Laura%22+author.last_name%3A%22Polakowski%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Polakowski+L[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AL+Polakowski%22" >Google Scholar </a> | <a target="_blank" href=https://orcid.org/0000-0002-5476-7632 ><img src="/assets/orcid_24x24-c3dd8466870e6d6844746d0390885a978817f110ed6b16957bc1ad3a282af054.png" /> </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-17"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Brewinski Isaacs, M. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Margaret%22+author.last_name%3A%22Brewinski Isaacs%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Brewinski Isaacs+M[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AM+Brewinski Isaacs%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-18"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Yen, C. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Catherine%22+author.last_name%3A%22Yen%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Yen+C[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AC+Yen%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-19"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Tomaras, G. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Georgia%22+author.last_name%3A%22Tomaras%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Tomaras+G[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AG+Tomaras%22" >Google Scholar </a> | <a target="_blank" href=https://orcid.org/0000-0001-8076-1931 ><img src="/assets/orcid_24x24-c3dd8466870e6d6844746d0390885a978817f110ed6b16957bc1ad3a282af054.png" /> </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-20"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Corey, L. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Lawrence%22+author.last_name%3A%22Corey%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Corey+L[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AL+Corey%22" >Google Scholar </a> | <a target="_blank" href=https://orcid.org/0000-0002-2179-2436 ><img src="/assets/orcid_24x24-c3dd8466870e6d6844746d0390885a978817f110ed6b16957bc1ad3a282af054.png" /> </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-21"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Janes, H. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Holly%22+author.last_name%3A%22Janes%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Janes+H[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AH+Janes%22" >Google Scholar </a> </p> </div> <div class="f-dropdown content large" data-dropdown-content id="author-affiliation-22"> <p><p class="affiliations"><sup>1</sup>Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>2</sup>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America</p><p class="affiliations"><sup>3</sup>Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>4</sup>Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America</p><p class="affiliations"><sup>5</sup>SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa</p><p class="affiliations"><sup>6</sup>Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>7</sup>Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America</p><p class="affiliations"><sup>8</sup>Access to Advanced Health Institute, Seattle, United States of America</p><p class="affiliations"><sup>9</sup>National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America</p><p class="affiliations"><sup>10</sup>Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America</p></p> <p> Find articles by Gray, G. in: <a target="_blank" href="/search/results?q=author.first_name%3A%22Glenda E.%22+author.last_name%3A%22Gray%22&#x0026;search_type=advanced" >JCI </a> | <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&#x0026;db=pubmed&#x0026;term=Gray+G[au]&#x0026;dispmax=50" >PubMed </a> | <a target="_blank" href="http://scholar.google.com/scholar?q=%22author%3AG+Gray%22" >Google Scholar </a> </p> </div> <p class='publication_date'> Published April 3, 2025 - <a class='show-more' data-dropdown='full-publication-dropdown' href='javascript:void(0);'> More info </a> </p> <div class='f-dropdown content large' data-dropdown-content='' id='full-publication-dropdown'> <div class='copyright'> <i> J Clin Invest. </i> <a href="https://doi.org/10.1172/JCI186927">https://doi.org/10.1172/JCI186927</a>. <br> Copyright © 2025, Violari et al. This work is licensed under the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. </div> <div class='publication_date'> Published April 3, 2025 - <a href="#version_history">Version history</a> </div> </div> <a href="/articles/view/186927/pdf">View PDF <img class="article-tools-icon" src="//dm5migu4zj3pb.cloudfront.net/images/adobe_pdf_file_icon.png" /></a> <div class="content_well"> <a class="in-page" name="ABS"></a><dl class="article-section" data-accordion=""><dd class="accordion-navigation active"> <a href="#section-abstract"><span class="toggle-icon"></span><span class="section-title">Abstract</span></a><div id="section-abstract" class="content active"> <p><b>BACKGROUND.</b> The neonatal immune system is uniquely poised to generate broadly neutralizing antibodies (bnAbs) and thus infants are ideal for evaluating HIV vaccine candidates. We present the design and safety of a new-in-infants glucopyranosyl lipid A (GLA)-stable emulsion (SE) adjuvant admixed with a first-in-infant CH505 transmitter-founder (CH505TF) gp120 immunogen designed to induce precursors for bnAbs against HIV.</p> <p><b>METHODS.</b> HVTN 135 is a phase I randomized, placebo-controlled trial of CH505TF+GLA-SE or placebo. Healthy infants aged ≤ 5 days, born to mothers living with HIV but HIV nucleic acid negative at birth were randomized to five doses of CH505TF + GLA-SE or placebo at birth and 8, 16, 32, and 54 weeks.</p> <p><b>RESULTS.</b> 38 infants (median age = 4 days; interquartile range 4, 4.75 days) were enrolled November 2020 to January 2022. Among 28 (10) infants assigned to receive CH505TF + GLA-SE (placebo), most (32/38) completed the 5-dose immunization series and follow-up (35/38). Solicited local and systemic reactions were more frequent in vaccine (8, 28.6% local; 16, 57.1% systemic) vs. placebo recipients (1, 10% local, <i>P</i> = 0.25; 4, 40.0% systemic, <i>P</i> = 0.38). All events were Grade 1 except two Grade 2 events (pain, lethargy). Serious vaccine-related adverse events were not recorded.</p> <p><b>CONCLUSIONS.</b> This study illustrates the feasibility of conducting trials of new-in-infants adjuvanted HIV vaccines in HIV-exposed infants receiving standard infant vaccinations. The safety profile of the CH505TF + GLA-SE vaccine was reassuring.</p> <p><b>TRIAL REGISTRATION.</b> ClinicalTrials.gov NCT04607408.</p> <p><b>FUNDING.</b> The trial was funded through National Institute of Allergy and Infectious Disease of the National Institutes of Health under grants UM1 AI068614 (HVTN Leadership and Operations Center), UM1 AI068635 (HVTN Statistical and Data Management Center), and UM1 AI068618 (HVTN Laboratory Center).</p> </div> </dd></dl> <a class="in-page" name="sd"></a><dl class="article-section" data-accordion=""><dd class="accordion-navigation active"> <a href="#supplemental-material"><span class="toggle-icon"></span><span class="section-title">Supplemental material</span></a><div id="supplemental-material" class="content active"> <p><a href="/articles/view/186927/sd/1"> View </a></p> <p><a href="/articles/view/186927/sd/2"> View Biorender License associated with Figure 1.</a></p> </div> </dd></dl> </div> <dl class='article-section' data-accordion> <dd class='accordion-navigation active'> <a href='#version_history'> <span class='toggle-icon'></span> <span class='section-title'>Version history</span> </a> <div class='content active' id='version_history'> <ul> <li> Version 1 (April 3, 2025): In-Press Preview </li> </ul> </div> </dd> </dl> </div> <div class="large-3 columns show-for-large-up"> <div id='sidebar-container'> <div id='sidebar'> <div class='non-sticky-content'> <h4 class='subheader'>Article tools</h4> <ul class='side-nav' id='article-tools'> <li class='hide-for-small'> <a href="/articles/view/186927/pdf">View PDF <img class="article-tools-icon" src="//dm5migu4zj3pb.cloudfront.net/images/adobe_pdf_file_icon.png" /></a> </li> <li><a href="/articles/view/186927/cite">Download citation information</a></li> <li><a href="/eletters/submit/186927">Send a comment</a></li> <li><a href="/kiosks/terms">Terms of use</a></li> <li><a href="/kiosks/publish/abbreviations">Standard abbreviations</a></li> <li><a href="/feedback?reference=186927">Need help? Email the journal</a></li> <script> var addthis_share = { email_template: 'jci_share_article', email_vars: { short_title: 'Safety and implementation of phase 1 randomized...', author_list: 'Avy Violari, Kennedy Otwombe, William Hahn, Shiyu Chen, Deirdre Josipovic, Vuyelwa Baba, Asimenia Angelidou, Kinga K. Smolen, Ofer Levy, Nonhlanhla N. Mkhize, Amanda S. Woodward Davis, Troy M. Martin, Barton F. Haynes, Wilton B. Williams, Zachary K. Sagawa, James G. Kublin, Laura Polakowski, Margaret Brewinski Isaacs, Catherine Yen, Georgia Tomaras, Lawrence Corey, Holly Janes, Glenda E. Gray', } } </script> <div class="addthis_sharing_toolbox" data-title="JCI - Safety and implementation of phase 1 randomized GLA-SE-adjuvanted CH505TF gp120 HIV vaccine trial in newborns"></div> </ul> <h4 class='subheader'>Metrics</h4> <div class='altmetric-embed centered' data-badge-popover='left' data-badge-type='medium-donut' data-doi='10.1172/JCI186927'></div> <ul class='side-nav' id='article-metrics'> <li><a href="/articles/view/186927/usage">Article usage</a></li> <li> <a href="/articles/view/186927/citations">Citations to this article <span class='article-citation-count'></span> </a></li> </ul> </div> <div class='sticky-content'> <h4 class='subheader'>Go to</h4> <div id='goto'> <ul class='side-nav'> <li><a href="#top">Top</a></li> <li><a href="#ABS">Abstract</a></li> <li><a href="#sd">Supplemental material</a></li> <li><a href="#version_history">Version history</a></li> </ul> </div> </div> </div> </div> </div> </div> <div class="row hide-for-small"> <div class="medium-12 columns"> <div style='width:100%; text-align: center;'> <div id='jci-article-interior-leaderboard-bottom'> <span class='secondary label'>Advertisement</span> <script> try { googletag.cmd.push(function() { googletag.display('jci-article-interior-leaderboard-bottom'); }) } catch(e){} </script> </div> </div> </div> </div> </div> <div class='large-2 medium-3 hide-for-small columns' style='padding: 12px 9px 12px 9px;'> <div style='width:100%; text-align: center;'> <div class='ad-interior-r-sideboard' id='jci-article-interior-skyscraper-right-col'> <span class='secondary label'>Advertisement</span> <script> try { googletag.cmd.push(function() { googletag.display('jci-article-interior-skyscraper-right-col'); }) } catch(e){} </script> </div> </div> </div> </div> </div> </div> </div> </div> <div id='footer'> <div class='row panel-padding'> <div class='small-6 columns'> <div id='social-links'> <a onclick="trackOutboundLink(&#39;/twitter?ref=footer&#39;);" href="/twitter"><img title="Twitter" src="/assets/social/twitter-round-blue-78025a92064e3594e44e4ccf5446aefeafba696cd3c8e4a7be1850c7c9f62aba.png" /></a> <a onclick="trackOutboundLink(&#39;/facebook?ref=footer&#39;);" href="/facebook"><img title="Facebook" src="/assets/social/facebook-round-blue-2787910d46dcbdbee4bd34030fee044e5a77cfda2221af9191d437b2f5fadeb1.png" /></a> <a href="/rss"><img title="RSS" src="/assets/social/rss-round-color-6f5fa8e93dc066ee4923a36ba6a7cb97d53c5b77de78a2c7b2a721adc603f342.png" /></a> </div> <br> Copyright &#169; 2025 <a href="http://www.the-asci.org">American Society for Clinical Investigation</a> <br> ISSN: 0021-9738 (print), 1558-8238 (online) </div> <div class='small-6 columns'> <div class='row'> <div class='small-12 columns'> <h4 class='notices-signup'>Sign up for email alerts</h4> <form action='https://notices.jci.org/subscribers/new' method='get'> <input name='utm_source' type='hidden' value='jci'> <input name='utm_medium' type='hidden' value='web'> <input name='utm_campaign' type='hidden' value='email_signup'> <input name='utm_content' type='hidden' value='footer'> <div class='row'> <div class='small-12 medium-9 columns'> <input name='email_address' placeholder='Your email address' required type='text'> </div> <div class='small-12 medium-3 columns'> <input class='button tiny orange' type='submit' value='Sign up'> </div> </div> </form> </div> </div> </div> </div> </div> </div> <!--[if gt IE 8]><!--><script src="/assets/application-27f18b5fe3b7302e5b3e3c6d7cf9bb3f54759fad32679209f5aef429b89f3aef.js"></script><!--<![endif]--> <!--[if (lt IE 9)]> <script src="/assets/ie8/application-8c033a599105d459c98ea08bf9ef15e25d3fed26e913e4a8de4a5101d04025fd.js"></script> <![endif]--> <script src="//s7.addthis.com/js/300/addthis_widget.js#pubid=ra-4d8389db4b0bb592" async="async"></script> <script src="//d1bxh8uas1mnw7.cloudfront.net/assets/embed.js" async="async"></script> <script type="text/javascript"> jQuery(document).ready(function() { ArticleStickyNav.init(); display_citation_count(186927); setMaxGaSize(jQuery('div.inner-wrap .fixed.show-for-large-up'), jQuery('div#section-graphical-abstract img')); }); </script> <!--[if lt IE 9]> <script src="/assets/ie8/ie8-1af1fadfa0df4a7f5fcf8fc444742398e0579e1d8aede97903d74bad8167eb5f.js"></script> <![endif]--> </body> </html>

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