A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds

被引：7

作者：

Usdan, Lisa ^{[1
]}

Patel, Sohil ^{[2
]}

Rodriguez, Hector ^{[3
]}

Xu, Xia ^{[4
]}

Lee, Dung-Yang

Finn, Daniel ^{[5
]}

Wyper, Hayley ^{[2
]}

Lowry, Francine S. ^{[4
]}

Mensa, Federico J. ^{[6
]}

Lu, Claire ^{[7
]}

Cooper, David ^{[7
]}

Koury, Kenneth ^{[7
]}

Anderson, Annaliesa S. ^{[7
]}

Tureci, Ozlem

Sahin, Ugur ^{[6
]}

Swanson, Kena A. ^{[7
]}

Gruber, William C. ^{[7
]}

Kitchin, Nicholas ^{[2
]}

机构：

[1] CNS Healthcare, Memphis, TN USA

[2] Pfizer, Vaccine Res & Dev, Honey Lane, Hurley SL6 6RJ, England

[3] Acevedo Clin Res Associates, Miami, FL USA

[4] Pfizer, Vaccine Res & Dev, Collegeville, PA USA

[5] Kentucky Pediat Adult Res, Bardstown, KY USA

[6] BioNTech, Mainz, Germany

[7] Pfizer, Vaccine Res & Dev, Pearl River, NY USA

来源：

CLINICAL INFECTIOUS DISEASES | 2024年 / 78卷 / 05期

关键词：

BNT162b2; vaccine; SARS-CoV-2; Omicron variant; booster; immunogenicity; UNITED-STATES; VACCINE;

D O I：

10.1093/cid/ciad718

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background Protection against contemporary severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants requires sequence-adapted vaccines.Methods In this ongoing phase 2/3 trial, 12-17-year-olds (n = 108), 18-55-year-olds (n = 313), and >55-year-olds (n = 306) who previously received 3 original BNT162b2 30-mu g doses, received a fourth dose (second booster) of 30-mu g bivalent original/Omicron-BA.4/BA.5-adapted BNT162b2 (BNT162b2-Omi.BA.4/BA.5). For comparisons with original BNT162b2, participants were selected from another phase 3 trial. Immunologic superiority 1 month after vaccination, with respect to 50% neutralizing titers (lower bound [LB] of 2-sided 95% confidence interval [CI] for geometric mean ratio [GMR], >1), and noninferiority with respect to seroresponse rates (LB of 2-sided 95% CI for rate difference, greater than -5%), for Omicron BA.4/BA.5 were assessed in >55-year-olds versus original BNT162b2 as a second booster. Noninferiority with respect to neutralizing titer level (LB of 2-sided 95% CI for GMR, > 0.67) and seroresponse rate (LB of 2-sided 95% CI for rate difference, greater than -10%) of Omicron BA.4/BA.5 immune response for BNT162b2-Omi.BA.4/BA.5 in 18-55 versus >55-year-olds was assessed.Results One month after vaccination in >55-year-olds, the model-adjusted GMR of Omicron BA.4/BA.5 neutralizing titers for the BNT162b2-Omi.BA.4/BA.5 versus BNT162b2 groups (2.91 [95% CI, 2.45-3.44]) demonstrated the superiority of BNT162b2-Omi.BA.4/BA.5. Adjusted difference in the percentages of >55-year-olds with seroresponse (26.77% [95% CI, 19.59-33.95]) showed noninferiority of BNT162b2-Omi.BA.4/BA.5 to BNT162b2. Noninferiority of BNT162b2-Omi.BA.4/BA.5 in 18-55-year-olds compared with >55-year-olds was met for model-adjusted GMR and seroresponse. Geometric mean titers in 12-17-year-olds increased from baseline to 1 month after vaccination. The BNT162b2-Omi.BA.4/BA.5 safety profile was similar to the profiles for booster doses of bivalent Omicron BA.1-modified BNT162b2 and original BNT162b2 reported in previous studies.Conclusions Based on immunogenicity and safety data up to 1 month after vaccination in participants who previously received 3 original BNT162b2 doses, a BNT162b2-Omi.BA.4/BA.5 30-mu g booster has a favorable benefit-risk profile.Clinical Trials Registration NCT05472038

引用

页码：1194 / 1203

页数：10

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