A Phase 1, Open-Label, Safety, Reactogenicity, and Immunogenicity Trial of RVX-sCPD9, a Live-Attenuated SARS-CoV-2, as a Booster Vaccine, Via the Intranasal Route in Previously Vaccinated Adults
National Institute of Allergy and Infectious Diseases (NIAID)
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.
Description
This Phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9 administered as an intranasal (IN) booster in previously vaccinated healthy adults. The study is designed as a non-randomized, open-label, dose-escalation trial assessing four dose levels of RVX-sCPD9 (10\^2, 10\^3, 10\^4, and 5 × 10\^4 FFU) delivered intranasally. A total of 80 participants will be enrolled, with 20 participants in each cohort. Eligibility will be determined at screening and confirmed again on Day 1 prior to study product administration. Participants will be healthy adults a…