Immunogenicity and safety of beta variant COVID-19 vaccine AZD2816 and AZD1222 (ChAdOx1 nCoV-19) as primary-series vaccination for previously unvaccinated adults in Brazil, South Africa, Poland, and the UK: a randomised, partly double-blinded, phase 2/3 non-inferiority immunobridging study

AZD2816 is a variant-adapted COVID-19 vaccine that expresses the full-length SARS-CoV-2 beta variant spike protein but is otherwise similar to AZD1222 (ChAdOx1 nCoV-19). This study aimed to evaluate the safety and immunogenicity of AZD1222 or AZD2816 (or both) primary-series vaccination in a cohort...

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Veröffentlicht in:The Lancet. Microbe 2024-08, Vol.5 (8), p.100863, Article 100863
Hauptverfasser: Costa Clemens, Sue Ann, Jepson, Brett, Bhorat, Qasim E, Ahmad, Abdullahi, Akhund, Tauseefullah, Aley, Parvinder K, Bansal, Himanshu, Bibi, Sagida, Kelly, Elizabeth J, Khan, Mark, Lambe, Teresa, Lombaard, Johan J, Matthews, Sam, Pipolo Milan, Eveline, Olsson, Urban, Ramasamy, Maheshi N, Moura de Oliveira Paiva, Maria Sanali, Seegobin, Seth, Shoemaker, Kathryn, Szylak, Ameena, Villafana, Tonya, Pollard, Andrew J, Green, Justin A, de Oliveira Paiva, Hugo Diógenes, Smith, Catherin C, Brites, Carlos, Sprinz, Eduardo, Vasconcellos, Eduardo, Badal-Faesen, Sharlaa, Koen, Anthonet, Burgess, Lesley, Engelbrecht, Johannes, Vekemans, Johan, Kobielusz-Gembala, Iwona, Jones, Colin, Hirsch, Ian, Aksyuk, Anastasia, Wilkins, Deidre, Stanely, Ann Marie, Petropoulos, Christos J, Wrin, Terri, Rugieri, Sidelcina, Bennet, Jaclyn A, Greffrath, Johann, Sorio, Guilherme L, Mantyka, Jolanta
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Zusammenfassung:AZD2816 is a variant-adapted COVID-19 vaccine that expresses the full-length SARS-CoV-2 beta variant spike protein but is otherwise similar to AZD1222 (ChAdOx1 nCoV-19). This study aimed to evaluate the safety and immunogenicity of AZD1222 or AZD2816 (or both) primary-series vaccination in a cohort of adult participants who were previously unvaccinated. In this phase 2/3, randomised, multinational, active-controlled, non-inferiority, immunobridging study, adult participants previously unvaccinated for COVID-19 were enrolled at 16 study sites in Brazil, South Africa, Poland, and the UK. Participants were stratified by age, sex, and comorbidity and randomly assigned 5:5:5:2 to receive a primary series of AZD1222 (AZD1222 group), AZD2816 (AZD2816 [4-week] group), or AZD1222-AZD2816 (AZD1222-AZD2816 group) at 4-week dosing intervals, or AZD2816 at a 12-week interval (AZD2816 [12-week] group) and evaluated for safety and immunogenicity through 180 days after dose 2. Primary outcomes were safety (rates of solicited adverse events occurring during 7 days and unsolicited adverse events occurring during 28 days after each dose) and immunogenicity (non-inferiority of pseudovirus neutralising antibody geometric mean titre [GMT], GMT ratio margin of 0·67, and seroresponse rate, rate difference margin of –10%, recorded 28 days after dose 2 with AZD2816 [4-week interval] against beta vs AZD1222 against ancestral SARS-CoV-2) in participants who were seronegative at baseline. This trial is registered with ClinicalTrials.gov, NCT04973449, and is completed. Between July 7 and Nov 12, 2021, 1449 participants were assigned to the AZD1222 group (n=413), the AZD2816 (4-week) group (n=415), the AZD1222-AZD2816 group (n=412), and the AZD2816 (12-week) group (n=209). Ten (2·6%) of 378 participants who were seronegative at baseline in the AZD1222 group, nine (2·4%) of 379 in the AZD2816 (4-week) group, eight (2·1%) of 380 in the AZD1222-AZD2816 group, and 11 (5·8%) of 191 in the AZD2816 (12-week) group had vaccine-related unsolicited adverse events. Serious adverse events were recorded in one (0·3%) participant in the AZD1222 group, one (0·3%) in the AZD2816 (4-week) group, two (0·5%) in the AZD1222-AZD2816 group, and none in the AZD2816 (12-week) group. Co-primary immunogenicity endpoints were met: neutralising antibody GMT (ratio 1·19 [95% CI 1·08–1·32]; lower bound greater than 0·67) and seroresponse rate (difference 1·7% [–3·1 to 6·5]; lower bound greater than –10%) at 28 days
ISSN:2666-5247
2666-5247
DOI:10.1016/S2666-5247(24)00078-8