Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Study

Summary

A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older after the Vaccination of 2 Doses of Inactivated Vaccines

Timeline

Start

2021-11-03

Primary completion

2022-02-18

Completion

2023-04-14

Outcome

Met primary endpoint

paper Over two months of surveillance, vaccine efficacy was 47.8% (95%CI: 22.6-64.7) according to the intention-to-treat principle. PMID 35686572 ↗

release “来自巴基斯坦、马来西亚的随机、双盲Ⅲ期数据显示，V-01序贯加强后的绝对保护力为61.35%，具有显著强优效性，满足WHO标准。” joincare.com ↗

Publications

• Wang XY, Mahmood SF, Jin F, Cheah WK, Ahmad M, Sohail MA, Ahmad W, Suppan VK, Sayeed MA, Luxmi S, Teo AH, Lee LY, Qi YY, Pei RJ, Deng W, Xu ZH, Yang JM, Zhang Y, Guan WX, Yu X. Efficacy of heterologous boosting against SARS-CoV-2 using a recombinant interferon-armed fusion protein vaccine (V-01): a randomized, double-blind and placebo-controlled phase III trial. Emerg Microbes Infect. 2022 Dec;11(1):1910-1919. doi: 10.1080/22221751.2022.2088406.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	V-01	Vaccine	10 ug	Intramuscular

Indications