| Autor: |
Gustavo H, Dayan, Nadine, Rouphael, Stephen R, Walsh, Aiying, Chen, Nicole, Grunenberg, Mary, Allen, Johannes, Antony, Kwaku Poku, Asante, Amit Suresh, Bhate, Tatiana, Beresnev, Matthew I, Bonaparte, Maria, Angeles Ceregido, Dmytro, Dobrianskyi, Bo, Fu, Marie-Helene, Grillet, Maryam, Keshtkar-Jahromi, Michal, Juraska, Jia Jin, Kee, Hannah, Kibuuka, Marguerite, Koutsoukos, Roger, Masotti, Nelson L, Michael, Humberto, Reynales, Merlin L, Robb, Sandra M, Villagómez Martínez, Fredrick, Sawe, Lode, Schuerman, Tina, Tong, John, Treanor, T Anh, Wartel, Carlos A, Diazgranados, Roman M, Chicz, Sanjay, Gurunathan, Stephen, Savarino, Saranya, Sridhar |
| Rok vydání: |
2022 |
| Zdroj: |
medRxiv : the preprint server for health sciences. |
| Popis: |
BackgroundCOVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern.MethodsWe conducted a global Phase 3, multi-stage efficacy study (NCT04904549) among adults aged ≥18 years. Participants were randomized 1:1 to receive two intramuscular injections 21 days apart of a bivalent SARS-CoV-2 recombinant protein vaccine with AS03-adjuvant (5 μg of ancestral (D614) and 5 μg of B.1.351 [beta] variant spike protein) or placebo. Symptomatic COVID-19 was defined as laboratory-confirmed COVID-19 with COVID-19-like illness (CLI) symptoms. The primary efficacy endpoint was the prevention of symptomatic COVID-19 ≥14 days after the second injection (post-dose 2 [PD2]).ResultsBetween 19 Oct 2021 and 15 Feb 2022, 12,924 participants received ≥1 study injection. 75% of participants were SARS-CoV-2 non-naïve. 11,416 participants received both study injections (efficacy-evaluable population [vaccine, n=5,736; placebo, n=5,680]). Up to 15 March 2022, 121 symptomatic COVID-19 cases were reported (32 in the vaccine group and 89 in the placebo group) ≥14 days PD2 with a vaccine efficacy (VE) of 64.7% (95% confidence interval [CI] 46.6; 77.2%). VE was 75.1% (95% CI 56.3; 86.6%) in non-naïve and 30.9% (95% CI -39.3; 66.7%) in naïve participants. Viral genome sequencing identified the infecting strain in 68 cases (Omicron [BA.1 and BA.2 subvariants]: 63; Delta: 4; Omicron and Delta: 1). The vaccine was well-tolerated and had an acceptable safety profile.ConclusionsA bivalent vaccine conferred heterologous protection against symptomatic infection with newly emergent Omicron (BA.1 and BA.2) in non-naïve adults 18–59 years of age.ClinicalTrials.govNCT04904549 |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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