drugset / Trial / NCT05366296
Safety, Reactogenicity, and Immunogenicity Study of a Lyophilized COVID-19 mRNA Vaccine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |