{"id":40618,"date":"2021-06-01T07:25:01","date_gmt":"2021-06-01T07:25:01","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=40618"},"modified":"2021-06-01T08:49:16","modified_gmt":"2021-06-01T08:49:16","slug":"novavax-reports-43-efficacy-against-b-1-351-south-african-variant-but-negative-impact-in-hiv-positive-participants","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/40618","title":{"rendered":"Novavax reports 43% efficacy against B.1.351 South African variant but negative impact in HIV positive participants"},"content":{"rendered":"
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Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n<\/div>\n

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On 5 May 2021, results from a phase 2\/a\/b study of the Novavaz NVX-CoV2373 vaccine reported 43% efficacy against the B.1.351 South African variant. Importantly, it also reported the results by HIV status, showing negative results in participants who were HIV positive.<\/span><\/strong><\/p>\n<\/div>\n

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The analysis included 2684 participants who were seronegative for SARS-CoV-2 at baseline and randomised (1:1) to vaccine or placebo injections. Of these, 94% were HIV negative and 6% were HIV positive, with results reported separately by HIV status. Although more than 4,300 participants were originally enrolled, one-third were later found to be seropositive for SARS-CoV-2 at baseline.<\/span><\/p>\n<\/div>\n

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This was a generally young population at low risk of COVID-19 (median age 32, with only 4% > 65 years) and the primary endpoint was mild\/moderate symptoms (rather than hospitalisation or mortality).<\/span><\/p>\n<\/div>\n

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Overall efficacy, seven days after the second dose, was 49.4% (95% CI: 6.1 to 72.8), based on 15 vs 29 cases in the active vs placebo group, respectively. At the time of the study, national incidence of the B.1.351 variant was approximately 93%.<\/span><\/p>\n<\/div>\n

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Among the HIV negative group, symptomatic COVID-19 was observed in 11 vs 27 participants in the active vs placebo groups respectively: efficacy 60.1% (95% CI: 19.9 to 80.1)<\/span><\/p>\n<\/div>\n

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The corresponding efficacy in HIV positive participants, based on 4 vs 2 cases in active vs placebo groups respectively, was 52.2% (95% CI: \u221224.8 to +81.7). This showed a negative impact of the vaccine, although the numbers in this subgroup were small.<\/span><\/p>\n<\/div>\n

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comment<\/span><\/h3>\n

The study discussion notes that these results are preliminary and that the B.1.351 sequencing analysis was post hoc.<\/span><\/strong><\/p>\n<\/div>\n

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Also that the vaccine effects in the HIV positive group represented a relatively small fraction of the trial population and the study was not powered for efficacy results by HIV status.<\/span><\/strong><\/p>\n<\/div>\n

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Reference<\/span><\/p>\n<\/div>\n

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Shinde V at al.\u00a0Efficacy of NVX-CoV2373 covid-19 vaccine against the B.1.351 variant. NEJM. DOI: 10.1056\/NEJMoa2103055. (5 May 2021).
\n<\/span>https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2103055<\/a><\/p>\n

This report was first posted on 9 May 2021.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Simon Collins, HIV i-Base On 5 May 2021, results from a phase 2\/a\/b study of the Novavaz NVX-CoV2373 vaccine reported 43% efficacy against the B.1.351 South African variant. Importantly, it also reported the results by HIV status, showing negative results …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282,292,278],"tags":[],"class_list":["post-40618","post","type-post","status-publish","format-standard","hentry","category-covid-19-hiv-and-covid-19-coinfection","category-covid-19-vaccine","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40618","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=40618"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40618\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=40618"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=40618"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=40618"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}