drugset / Trial / NCT05366296

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

NCT05366296 ↗

RandomizedSequentialQuadruple-blindPrevention

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 dose cohorts will be vaccinated Lyophilized COVID-19 mRNA Vaccine (RH109) The aim of the study is to assess the safety, reactogenicity and Immunogenicity of the candidate vaccine and to characterize its immunogenicity.

Timeline

Start
2022-07
Primary completion
2022-09
Completion
2023-01

Outcome

Outcome not reported

Stopped (Business): “business stragety”

Drugs

EvaluationDrugModalityDoseRoute
Comparator A Lyophilized COVID-19 mRNA Vaccine Messenger RNA (mRNA) 25 ug Intramuscular
Comparator A Lyophilized COVID-19 mRNA Vaccine Messenger RNA (mRNA) 50 ug Intramuscular

Indications