{"id":579,"date":"2009-10-20T22:11:23","date_gmt":"2009-10-21T03:11:23","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=579"},"modified":"2015-06-04T15:29:57","modified_gmt":"2015-06-04T19:29:57","slug":"well-that-was-fast-hiv-vaccine-trial-published","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/well-that-was-fast-hiv-vaccine-trial-published\/2009\/10\/20\/","title":{"rendered":"Well That Was Fast!  HIV Vaccine Trial Published"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-thumbnail wp-image-584\" title=\"canary\" src=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2009\/10\/canary-150x1501.jpg\" alt=\"canary\" width=\"150\" height=\"150\" \/>Remember the HIV vaccine trial <a href=\"https:\/\/www01.hjf.org\/apps\/internet\/hivnewscenter.nsf\/phase3pressrelease\" target=\"_blank\">press release<\/a>?\u00a0 The one announcing the first-ever positive result?<\/p>\n<p>Then the <a href=\"http:\/\/blogs.nejm.org\/index.php\/2009\/10\/12\/aids-vaccine-maybe-not-effective-after-all\/\" target=\"_blank\">backlash<\/a>, with people questioning how the analyses were done, and reported?<\/p>\n<p>Now, less than a month later, we have the scientific presentation <em>and the paper<\/em> appear on the same day.<\/p>\n<p>Read all about it <a href=\"http:\/\/www.hivvaccineenterprise.org\/content\/global-hiv-vaccine-enterprise-hails-significant-results-hiv-vaccine-study-thailand\" target=\"_blank\">here<\/a> and <a href=\"http:\/\/content.nejm.org\/cgi\/content\/full\/NEJMoa0908492\" target=\"_blank\">here<\/a>.<\/p>\n<p>If you want the view from 10,000 feet (why is that the chosen altitude for that cliche?), here it is:<\/p>\n<ul>\n<li>The vaccine strategy combines two vaccine generally thought to be ineffective on their own &#8212; canarypox ALVAC-HIV and glycoprotein 120 AIDSVAX B\/E &#8212; in a &#8220;prime and boost&#8221; approach<\/li>\n<li>Over 16,000 patients are enrolled in Thailand in a placebo-controlled trial<\/li>\n<li>The &#8220;modified intention-to-treat&#8221; analysis, which excludes those who are found to be HIV positive at entry, shows a modest but statistically significant protective effect, reducing the infection rate by about 30%<\/li>\n<li>There is a trend towards a protective effect in the intention-to-treat and per protocol analyses<\/li>\n<li>In those who were vaccinated and became infected, there was no effect on CD4 cell count or HIV RNA<\/li>\n<\/ul>\n<p>Numerous questions remain, many of them summarized in this accompanying <a href=\"http:\/\/content.nejm.org\/cgi\/content\/full\/NEJMe0909972\" target=\"_blank\">editorial<\/a>:\u00a0 Why did it work when the individual strategies didn&#8217;t?\u00a0 How durable is the protection?\u00a0 How do the strains causing infection relate to those in the vaccine?\u00a0 Did the per-protocol analysis fail to show a significant protective effect solely because of a smaller sample size?\u00a0 Would the vaccine work if tested on higher-risk populations?\u00a0 What effect will this study have on the ongoing vaccine development effort, both in the lab and in trials?<\/p>\n<p>Answers to some of these questions may be forthcoming.\u00a0 Regardless, the surprising results of this study serve as a reminder of just how mysterious the immune system remains &#8212; despite some incredibly smart people working on it with lots of resources.<\/p>\n<p>Because if you asked the vaccine cognoscenti to vote a little over a year ago on which strategy in clinical trials would end up with a positive result &#8212; the &#8220;prime and boost&#8221; one published today or the <a href=\"http:\/\/www.hvtn.org\/media\/pr\/step.html\" target=\"_blank\">adenovirus vector<\/a> approach &#8212;\u00a0 the latter would have won in a landslide.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Remember the HIV vaccine trial press release?\u00a0 The one announcing the first-ever positive result? Then the backlash, with people questioning how the analyses were done, and reported? Now, less than a month later, we have the scientific presentation and the paper appear on the same day. Read all about it here and here. If you [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,5,9,10],"tags":[44,52,196,423,424,456,750,965,983],"class_list":["post-579","post","type-post","status-publish","format-standard","hentry","category-health-care","category-hiv","category-infectious-diseases","category-policy","category-research","tag-aids","tag-aids-vaccine-meeting","tag-clinical-trial","tag-hiv","tag-hiv-clinical-trial","tag-hiv-vaccine-trial","tag-prevention","tag-vaccine","tag-vptn"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/579","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/comments?post=579"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/579\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=579"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=579"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=579"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}