Safety, Reactogenicity and Immunogenicity Study of ReCOV

Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate. In this phase I first-in-human clinical trial, healthy volunteers in two different age cohorts and two dose cohorts will be vaccinated twice with the candidate vaccine ReCOV. The aim of the study is to assess the safety and reactogenicity of the candidate vaccine and to characterize its immunogenicity.

Timeline

Start

2021-06-18

Primary completion

2022-05-05

Completion

2022-05-05

Publications

• Wynne C, Balgos A, Li J, Hamilton P, Tirador L, Jaen AM, Mo C, Yue Z, Ma Y, Wang Q, Wen R, Yao Z, Yu J, Yao W, Zhang J, Zheng H, Hong K, Zhu F, Liu Y. Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies. Infect Dis Ther. 2024 Jan;13(1):57-78. doi: 10.1007/s40121-023-00896-w. Epub 2023 Dec 16.

Drugs

Indications