| Autor: |
Ai-Min Hui, Jingxin Li, Li Zhu, Rong Tang, Huayue Ye, Mei Lin, Lei Ge, Xiyuan Wang, Fuzhong Peng, Zhenggang Wu, Xiling Guo, Yunfeng Shi, Hongxing Pan, Jiahong Zhu, Zhizhou Song, Jingjun Qiu, Wei Wang, Jianfei Zheng, Orkun Ozhelvaci, Svetlana Shpyro, Meghan Bushway, Evelyna Derhovanessian, Marie-Cristine Kühnle, Ulrich Luxemburger, Alexander Muik, Yoana Shishkova, Zakaria Khondker, Simin Hu, Eleni Lagkadinou, Uğur Şahin, Özlem Türeci, Fengcai Zhu |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
The Lancet Regional Health. Western Pacific, Vol 29, Iss , Pp 100586- (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2666-6065 |
| DOI: |
10.1016/j.lanwpc.2022.100586 |
| Popis: |
Summary: Background: BNT162b2, an mRNA vaccine against COVID-19, is being utilised worldwide, but immunogenicity and safety data in Chinese individuals are limited. Methods: This phase 2, randomised, double-blind, placebo-controlled trial included healthy or medically stable individuals aged 18–85 years enrolled at two clinical sites in China. Participants were stratified by age (≤55 or >55 years) and randomly assigned (3:1) by an independent randomisation professional to receive two doses of intramuscular BNT162b2 30 μg or placebo, administered 21 days apart. Study participants, study personnel, investigators, statisticians, and the sponsor's study management team were blinded to treatment assignment. Primary immunogenicity endpoints were the geometric mean titers (GMTs) of neutralising antibodies to live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seroconversion rates (SCR) 1 month after the second dose. Safety assessments included reactogenicity within 14 days of vaccination, adverse events (AEs), and clinical laboratory parameters. Randomised participants who received at least one dose were included in the efficacy and safety analyses on a complete case basis (incomplete/missing data not imputed). Results up to 6 months after the second dose are reported. Findings: Overall, 959 participants (all of Han ethnicity) who were recruited between December 5th, 2020 and January 9th, 2021 received at least one injection (BNT162b2, n=720; placebo, n=239). At 1 month after the second dose, the 50% neutralising antibody GMT was 294.4 (95% CI; 281.1–308.4) in the BNT162b2 group and 5.0 (95% CI; 5.0–5.0) in the placebo group. SCRs were 99.7% (95% CI; 99.0%–100.0%) and 0% (95% CI; 0.0%–1.5%), respectively (p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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