{"id":40674,"date":"2021-06-01T07:23:03","date_gmt":"2021-06-01T07:23:03","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=40674"},"modified":"2021-06-01T08:50:07","modified_gmt":"2021-06-01T08:50:07","slug":"covid-19-vaccine-candidate-from-gsk-and-sanofi-to-move-to-phase-3-placebo-controlled-study","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/40674","title":{"rendered":"COVID-19 vaccine candidate from GSK and Sanofi to move to phase 3 placebo controlled study"},"content":{"rendered":"
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Simon Collins, HIV i-Base<\/strong><\/span><\/p>\n<\/div>\n

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On 17 May 2021, GSK reported selected top-line results from a phase 2 study of a candidate COVID-19 vaccine being developed with Sanofi. This also included plans for a large international phase 3 study. [1]<\/span><\/strong><\/p>\n<\/div>\n

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The press release reported that the two-dose adjuvanted recombinant vaccine generated “95% -100% seroconversion rates” after the second dose. Also that \u201cneutralising antibodies that were \u201ccomparable to those generated after natural infection”.<\/span><\/p>\n<\/div>\n

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The phase 2 study included over 700 participants in the US and Honduras, with half aged 18 to 59 and half aged over 60.<\/span><\/p>\n<\/div>\n

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As context, this 95% to 100% is not an efficacy percentage and some currently authorised vaccines generate antibody responses that are much higher than from natural infection.<\/span><\/p>\n<\/div>\n

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The upcoming phase 3 study plans to enroll 35,000 volunteers, in a randomised placebo controlled study. This is controversial because all participants in research studies should be offered the current standard of care. Rather than comparing the new vaccine to a placebo, it is more ethical to compare it to one or more vaccines that are already authorised.\u00a0<\/span><\/p>\n<\/div>\n

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It might also be a challenge that many countries will also have already vaccinated people at highest risk, based on age or other comorbidities. This might make enrolment using the current design difficult.<\/span><\/p>\n<\/div>\n

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Other studies include whether a lower dose can be used as a booster.<\/span><\/p>\n<\/div>\n

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In this partnership, Sanofi provides the recombinant antigen and GSK provides the pandemic adjuvant.\u00a0<\/span><\/p>\n<\/div>\n

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GSK is also working with CureVac on an mRNA COVID vaccine. [2]<\/span><\/p>\n<\/div>\n

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

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  1. GSK press statement. Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial. (17 May 2021).
    \n<\/span>https:\/\/www.gsk.com\/en-gb\/media\/press-releases\/sanofi-and-gsk-covid-19-vaccine-candidate-demonstrates-strong-immune-responses-across-all-adult-age-groups-in-phase-2-trial<\/a><\/li>\n
  2. Joint press statement.\u00a0GSK and CureVac to develop next generation mRNA COVID-19 vaccines. (3 February 2021).
    \n    https:\/\/www.curevac.com\/en\/2021\/02\/03\/gsk-and-curevac-to-develop-next-generation-mrna-covid-19-vaccines<\/a><\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 17 May 2021, GSK reported selected top-line results from a phase 2 study of a candidate COVID-19 vaccine being developed with Sanofi. This also included plans for a large international phase 3 study. [1] The …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[292,278],"tags":[],"class_list":["post-40674","post","type-post","status-publish","format-standard","hentry","category-covid-19-vaccine","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40674","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=40674"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40674\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=40674"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=40674"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=40674"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}