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Safety, Reactogenicity, and Immunogenicity Study of a Lyophilized COVID-19 mRNA Vaccine

Covid19 Clinical Trial

Official title:
A Randomized, Observer-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of One Dose Booster by A Lyophilized COVID-19 mRNA Vaccine in Adults Aged 18 to 60 Years

Clinical Trial 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 clinical trial, healthy volunteers in two dose cohorts will be vaccinated on a booster dose with RH109 Vaccine or placebo vaccine. The aim of the study is to assess the safety valuate the safety, reactogenicity, and immunogenicity of RH109 Vaccine.

Clinical Trial Description

Participants will be enrolled into 2 ascending dose (RH109 low-dose 25 μg, high-dose 50 μg) cohorts randomly. Approximately 24 eligible participants, 12 for each cohort, will be randomized with a 3:1 ratio (RH109 :109: Placebo). The study will progress in a sequential manner, with the low-dose cohort being enrolled and dosed first. Dose escalation from low-dose to high-dose cohort is contingent on a review of safety data of the low-dose cohort through to 7 days following the vaccination by a Safety Monitoring Committee (SMC). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05351450
Study type Interventional
Source Jiangsu Rec-Biotechnology Co., Ltd.
Contact Jianhui Zhang, CMO
Phone +8613699297751
Email zhangjh@recbio.cn
Status Not yet recruiting
Phase Phase 1
Start date July 2022
Completion date May 2023
View Details
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