Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273

Summary

Phase 1, open-label, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of RVM-V001 administered as a single intramuscular injection in healthy adults. Three dose levels will be evaluated, with progression from low- to high-dose level based on the assessment of safety and tolerability. The study will be conducted at one or more sites in Australia.

Timeline

Start

2022-09-12

Primary completion

2023-06-02

Completion

2023-06-02

Outcome

Outcome not reported

Stopped: “The landscape of the study area changed, making it impossible to continue the study.”

Drugs

Indications