drugset / Trial / NCT07703475

A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine

NCT07703475 ↗

Phase 1 Not yet recruiting 80 enrolled National Institute of Allergy and Infectious Diseases (NIAID)
Non-randomizedSequentialOpen-labelPrevention

Summary

This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9, given Intranasally (IN), as a booster dose to previously vaccinated healthy adults. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating four dose levels of RVX-sCPD9 administered IN (10\^2, 10\^3, 10\^4, 5 x 10\^4 FFU). A sample size of 80 participants (20 participants in each cohort). The primary objective is to evaluate the safety and reactogenicity of a single IN administration of 4 ascending dosages of RVX-sCPD9 in previously vaccinated healthy adults.

Timeline

Start
2026-08-15
Primary completion
2027-11-15
Completion
2027-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject RVX-sCPD9 Vaccine 100 unknown Intranasal
Subject RVX-sCPD9 Vaccine 1000 unknown Intranasal
Subject RVX-sCPD9 Vaccine 10000 unknown Intranasal
Subject RVX-sCPD9 Vaccine 50000 unknown Intranasal

Indications