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href="https://blogs.nature.com/spoonful/2013/08/compound-kills-drug-resistant-tuberculosis-through-novel-mechanism.html" rel="prev">Compound kills drug-resistant tuberculosis through novel mechanism</a></div></li> <li class="next wpn-ellipsis"><div><span class="wpn-nav-label">Next post</span><a href="https://blogs.nature.com/spoonful/2013/08/discovery-of-gene-variant-lends-muscle-to-understanding-of-statins-side-effects.html" rel="next">Discovery of gene variant lends muscle to understanding of statins’ side-effects</a></div></li> </ul></div></nav><p class="article-type"><span class="journal-title">Nature Medicine</span><span class="divider"> | </span>Spoonful of Medicine</p><h1 class='wpn-post-title entry-title article-heading'><a href='https://blogs.nature.com/spoonful/2013/08/intravenous-vaccine-for-malaria-offers-robust-protection-in-small-clinical-trial.html'>Intravenous vaccine for malaria offers robust protection in small clinical trial</a></h1><p class="wpn-byline"><time datetime="2013-08-08T02:05:33-05:00" pubdate><span class="published"><abbr class="value" title="2013-08-08">08 Aug 2013 </abbr>|<abbr class="value" title="02:05:33-0500"> 02:05 EST</abbr></span></time><span class="divider"> | </span>Posted by <span class="author vcard"><a class="url fn n" href="https://blogs.nature.com/spoonful/author/Liz-Devitt" title="Liz Devitt">Liz Devitt</a></span><span class="divider"> | </span><span class="category"><span class="before">Category: </span><a href="https://blogs.nature.com/spoonful/category/infectious-diseases" rel="tag">Infectious diseases</a>, <a href="https://blogs.nature.com/spoonful/category/malaria" rel="tag">Malaria</a></span> </p> </header> <section> <div class="wpn-entry-content content"> <p><a class="wpn-image-link" href="https://blogs.nature.com/spoonful/files/2013/08/mosquito.jpg"><img class="alignright size-full wp-image-5209 wpn-image" title="mosquito" alt="mosquito" src="https://blogs.nature.com/spoonful/files/2013/08/mosquito.jpg" width="240" height="205" /></a></p> <p>Almost half the world’s population lives in areas where malaria infection is a risk, yet no licensed vaccines exist to prevent this red blood cell parasite from <a href="https://www.who.int/vaccine_research/diseases/soa_parasitic/en/index4.html">causing almost half a million deaths</a> each year. However, in a study<a href="https://www.sciencemag.org/content/early/2013/08/07/science.1241800.abstract"> published online today</a> in <i>Science</i>, researchers report on a new vaccine that provided remarkable protection against <i>Plasmodium falciparum</i>, considered the deadliest of the four malaria strains.</p> <p>“With this intravenous vaccine, we are striving to reach the World Health Organization goal of a [malaria] vaccine with 80 percent efficacy by 2025,” <a href="https://www.niaid.nih.gov/about/directors/biography/Pages/biography.aspx">Anthony Fauci</a>, director of the US National Institute of Allergy and Infectious Diseases (NIAID), in Bethesda, Maryland, told <i>Nature Medicine. </i>The clinical study was led by <a href="https://www.niaid.nih.gov/labsandresources/labs/aboutlabs/vrc/cellularimmunologylaboratory/Pages/seder.aspx">Robert Seder</a>, an immunologist at the NIAID Vaccine Research Center, and involved a vaccine developed by Stephen Hoffman and his colleagues at <a href="https://www.sanaria.com/">Sanaria</a>, a biotechnology company based in Rockville, Maryland.</p> <p>Scientists have spent decades trying to block <i>Plasmodium</i> infections at different stages of the <a href="https://www.niaid.nih.gov/topics/malaria/pages/lifecycle.aspx">parasite’s life cycle</a>—from the sporozoite that migrates out of the mosquito salivary gland and into host liver cells, to the merozoites that invade red blood cells before further developing into reproducing gametocytes.</p> <p>To date, only one experimental vaccine, called <a href="https://www.nature.com/nm/journal/v19/n2/box/nm.3083_BX1.html">RTS,S or Mosquirix</a>, developed by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative, with funding from the Bill & Melinda Gates Foundation, has demonstrated a consistent protective effect. It is made with a combination of antigens from part of a sporozoite and a hepatitis B virus surface receptor. <a href="https://www.nature.com/nm/journal/v17/n11/full/nm1111-1329b.html">Early results</a> suggested that three doses of the vaccine could cut the risk of infection among children aged 5 months to 17 months by half. But last year the <a href="https://www.nature.com/nm/journal/v18/n12/full/nm1212-1723.html">results of a phase 3 clinical trial</a> indicated that it offered only about 30–35% protection when given to infants between 6 weeks and 12 weeks of age.</p> <p>Seder and his colleagues set their sights on developing a vaccine with at least 80% efficacy and<b> </b>also<b> </b>decided to focus on stopping malarial infections at the sporozoite stage—before the parasite ever gets into the red blood cells. The phase 1 clinical trial reported today included a total of 34 adults completing a series of intravenous vaccines at varying doses, with the most promising results at the highest dose levels. Six adults who received five vaccine injections at the highest dose all showed complete protection after they were subsequently infected deliberately with <i>P. falciparum</i>, while six of nine adults who received a series of four of the high-dose vaccines experienced similar protection following the immunization schedule.</p> <p><span id="more-5208"></span>The idea of priming the immune system to react against the sporozoite form, rather than waiting until the red blood cells are already infected, has a long history. Here are some of the highlights:</p> <ul> <li><a href="https://www.med.nyu.edu/biosketch/nusser01">Ruth Nussenzweig</a>, a microbiologist at the New York University School of Medicine, showed in a 1967 <i>Nature</i> paper that mice gained immunity to malaria after injections of inactivated sporozoites.</li> <li>Human volunteers <a href="https://www.ncbi.nlm.nih.gov/pubmed/808142">immunized with inactivated sporozoites</a> of <i>P. falciparum </i>and <i>P. vivax </i>in the 1970s were protected from malaria for at least three months after subsequent bites from infected mosquitoes.</li> <li>Nussenzweig and her colleagues pinpointed the source of host immune system activation by sporozoites—the circumsporozoite protein (CSP) antigen—<a href="https://www.ncbi.nlm.nih.gov/pubmed/6957883">in 1982</a>. Other scientists then used sequences from the gene encoding CSP to synthesize a malarial vaccine, called SPf66, which entered clinical trials <a href="https://www.ncbi.nlm.nih.gov/pubmed/2884410">in 1987</a>, but didn’t show consistent efficacy.</li> <li>Around the same time in the 1980s, development of the <a href="https://www.worldmalariaday.org/download/partners/Updated_RTSS_FactSheet_21_April_2010.pdf">RTS,S vaccine began</a>, combining the CSP protein with an immune-boosting hepatitis B surface receptor antigen.</li> <li><a href="https://www.ncbi.nlm.nih.gov/pubmed/11930326">In 2002</a>, an 11-person study showed that more than 1,000 bites with irradiated mosquitoes harboring infectious sporozoites of <i>P. falciparum</i> could protect people from a new malaria infection for up to 42 weeks.</li> <li>Three years later, scientists <a href="https://www.ncbi.nlm.nih.gov/pubmed/15580261">developed a vaccine using genetically modified sporozoites</a> that could infect liver cells but didn’t progress to further stages of the parasite’s life cycle.</li> </ul> <p>Building on that foundation, Seder’s team reasoned that intravenous delivery of whole sporozoites weakened by irradiation might generate even greater immunity than previous approaches. Although injecting vaccines directly into veins isn’t the most practical way to protect a lot of people against malaria—the majority of vaccines, including RTS,S, are injected into muscle or under skin—<a href="https://www.ncbi.nlm.nih.gov/pubmed/21903775">earlier work showed</a> the intravenous route created a more vigorous response in the immune system of non-human primates than that produced by vaccine injections under the skin.</p> <p>“The intravenous vaccine gives proof that we can get to high levels of prevention,” says Fauci. More trials are planned to determine the best vaccine dose and injection intervals, and then researchers will look for a better way to deliver it, he says. That feasibility issue is important, notes <a href="https://www.jenner.ac.uk/prof-adrian-hill">Adrian Hill</a>, director of the Jenner Institute at the University of Oxford, UK, and part of the research team working on the RTS,S vaccine. “There’s no precedent for anything like an intravenous vaccine being used or manufactured,” he says.</p> <p>Image by dr_relling via <i><a href="https://www.flickr.com/photos/7955467@N03/2783124139">Flikr.com</a></i></p> </div> </section> <div class="wpn-entry-meta"> <aside> <div class="article-tools cleared"> <h2 class="hidden">Article tools</h2> <ul id="wpn-share-post-5208" class="wpn-entry-user-actions"> <li class="wpn-entry-comment-link"><a class="comments-link" href="https://blogs.nature.com/spoonful/2013/08/intravenous-vaccine-for-malaria-offers-robust-protection-in-small-clinical-trial.html#comments" title="Comment on Intravenous vaccine for malaria offers robust protection in small clinical trial">1 Comment</a></li> <li class="sendtofriend"><a 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class="wpn-comment-meta wpn-upper"><p class="datetime"><time datetime="2013-08-08T19:13:59-05:00" pubdate><abbr class="published" title="2013-08-08T19:13:59-0500">08 Aug 2013 19:13 EST</abbr></time></p><p class="moderation"> <a class="report" href="?action=report&comment=2431#comment-2431">Report this comment</a> </p> </div><dl> <dt><span class="comment-author vcard"><cite class="fn">Joseph Symond</cite> said: </span></dt> <dd><p> Here is the issue I see with this, as has already been proven with the previously touted vaccine ‘Mosquirix’.</p> <p> 1) P. falciparum, while only a parasite, is incredibly adaptive and intelligent (if that term can be used), and has proven this to us over it’s +100 million years of existence.</p> <p> 2) Adrian HIll states: “There’s no precedent for anything like an intravenous vaccine being used or manufactured,” Really? Let’s look back at history: Before ‘Europeans’ (i.e. the English) entered into Africa to expand the Empire, the population of the African continent were mostly already resistant to the malaria parasite via the very same means which are being applauded here today. Immunity was established by being exposed to the parasite itself ‘intravenously’ (albeit the needle was a mosquitoes’ proboscis). Those who survived, were immune and it was recorded that even newborn babies were born with resistance to Malaria. VOILA! However, the Europeans did not have this immunity, and died by the boatload upon arrival (because the locals were physically tougher than they were, AND immune to Malaria) so they developed ‘quinine’ to protect themselves. Believing in their wisdom that everyone needed it, they gave it to the Africans, and completely removed their immunity to Malaria. Thus began the problem we face to this day.</p> <p> 3) + 200-years later, after causing the devastation that we see today that has cost the world trillions of dollars in every way, we now decide that exposing those same people to the parasite so as to build resistance is something new and noteworthy? It may work. It may not. But it is hardly revolutionary.</p> <p> 4) As has been proven over and again, the more time that passes between discovery, approval and implementation, the less effective any vaccine will be. The more testing that is done, the more widespread the ability for the parasite to adapt will be. By the time a drug is approved for use, it is largely ineffective. Research refund anyone? Doubt it. Do NGO’s like the Gates Foundation care? Clearly not. Ea$y come, ea$y go.</p> <p> 5) Ultimately, failure means billion$ more will be pumped into the scientific community to find yet another vaccine to repeat the process. This cycle will go on forever until someone runs out of money (and it won’t ever be the researchers – they’re like hedge fund managers, win or lose, they get paid). So what is the motivation to ever succeed?</p> <p> Just my two cents worth. I’ve been in this business for over 13-years and haven’t seen a substantial, long-term breakthrough yet. And really don’t ever expect one. But I’m sure the people behind this are far smarter than I and have thought all of this through. Just as they thought through the ramifications of DDT, DEET, and the LLTN’s that no longer work, yet are STILL being paid for with our donations and rolled out by the tens of millions by the Mosquito Net Mafia (Malaria No More/Nothing But Nets/Exxon et al). </p> <p> A cynic I may be, but history supports my statements, and nothing will ever change while everyone is getting paid to fail.</p> </dd> </dl><div class="wpn-comment-meta wpn-lower"> </div>  </article> </li> </ol>  <ol class="after-comments"><div id="wp-temp-form-div"> <p class="must-log-in">You need to <a href="https://idp.nature.com/login/natureuser/?target=http%3A%2F%2Fblogs.nature.com%2Fspoonful%2F2013%2F08%2Fintravenous-vaccine-for-malaria-offers-robust-protection-in-small-clinical-trial.html%3Fcookie-test%3D0">log in</a> or <a href="https://idp.nature.com/register/natureuser">register</a> to comment.</p> </div></ol> </div> </div></section>  </div> <div class="col" id="extranav"> <div id="wpn-primary" class="wpn-id-primary sidebar aside"> <div class="current-issue-box" id="wpn-journal-nav"> <div class="wrap"><a href="https://www.nature.com/nm/journal/v21/n2/index.html"><img alt="" class="journal-cover" src="https://www.nature.com/nm/journal/v21/n2/images/homecover.gif"/><h1>Current issue</h1></a><span class="date">February 2015, Volume 21 No 2</span><ul class="toc"><li><a href="https://www.nature.com/nm/index.html">Journal home</a></li><li><a href="https://www.nature.com/nm/site/index.html">About</a></li><li rel="contents"><a href="https://www.nature.com/nm/journal/v21/n2/index.html">Current issue</a></li><li><a href="https://secure.nature.com/subscribe/nm">Subscribe</a></li><li><a href="https://www.nature.com/librec/svc/request/makeCommRequest?id=10">Recommend to library</a></li></ul></div><ul class="footer col4 clear"><li class="ealert"><a href="https://www.nature.com/nams/svc/myaccount/save/alert?list_id=5">E-alert</a></li><li class="rss"><a href="https://blogs.nature.com/spoonful/feed/">RSS</a></li><li class="facebook"><a href="https://www.facebook.com/pages/Nature-Medicine/193691346949">Facebook</a></li><li class="twitter"><a href="https://twitter.com/NatureMedicine">Twitter</a></li></ul></div><div id="submit-box"> <a href="https://blogs.nature.com/">nature.com blogs home</a> </div> <div id="wpn-npg-recent-comments-widget-2" class="wpn-widget wpn-comment-text wpn-npg-recent-comments-widget wpn- wpn-cache-miss"><h2 class="box-heading">Recent comments</h2><ul> <li><div><q>Interesting.</q> ... <a href="https://blogs.nature.com/spoonful/2014/06/real-time-tissue-analysis-could-guide-brain-tumor-surgery.html#comment-3127" class="more-link">Read more</a></div><span class="comment-author vcard">-- <cite class="fn">KONG DERICK NJIKEH</cite></span><h2 class="wpn-post-title"><a href="https://blogs.nature.com/spoonful/2014/06/real-time-tissue-analysis-could-guide-brain-tumor-surgery.html">Real-time tissue analysis could guide brain tumor surgery</a></h2></li> <li><div><q>Great work. 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