TY - JOUR
T1 - Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 Protein Vaccine
AU - VAT00008 Study Team
AU - Dayan, Gustavo H
AU - Rouphael, Nadine
AU - Walsh, Stephen R
AU - Chen, Aiying
AU - Grunenberg, Nicole
AU - Allen, Mary
AU - Antony, Johannes
AU - Asante, Kwaku Poku
AU - Bhate, Amit Suresh
AU - Beresnev, Tatiana
AU - Bonaparte, Matthew I
AU - Ceregido, Maria Angeles
AU - Dobrianskyi, Dmytro
AU - Fu, Bo
AU - Grillet, Marie-Helene
AU - Keshtkar-Jahromi, Maryam
AU - Juraska, Michal
AU - Kee, Jia Jin
AU - Kibuuka, Hannah
AU - Koutsoukos, Marguerite
AU - Masotti, Roger
AU - Michael, Nelson L
AU - Reynales, Humberto
AU - Robb, Merlin L
AU - Villagómez Martínez, Sandra M
AU - Sawe, Fredrick
AU - Schuerman, Lode
AU - Tong, Tina
AU - Treanor, John
AU - Wartel, T Anh
AU - Diazgranados, Carlos A
AU - Chicz, Roman M
AU - Gurunathan, Sanjay
AU - Savarino, Stephen
AU - Sridhar, Saranya
PY - 2023/1/13
Y1 - 2023/1/13
N2 - BACKGROUND: COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern.METHODS: We 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]).RESULTS: Between 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.CONCLUSIONS: A 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.
AB - BACKGROUND: COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern.METHODS: We 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]).RESULTS: Between 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.CONCLUSIONS: A 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.
U2 - 10.1101/2022.12.05.22282933
DO - 10.1101/2022.12.05.22282933
M3 - Article
C2 - 36523415
JO - medrxiv
JF - medrxiv
ER -