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.
Provides written informed consent before initiation of any study procedures.
Able to understand and agree to comply with planned study procedures and be available for all study visits.
Non-pregnant adults, 18 through 64 years of age at the time of study product administration.
Participants of childbearing potential* must agree to use or have practiced true abstinence** or use at least one acceptable primary form of contraception***.
Positive SARS-CoV-2 PCR at screening.
Abnormal vital signs (Grade 1 or higher)*.
Self-reported or medically documented SARS-CoV-2 infection (regardless of whether symptomatic or asymptomatic) within 16 weeks prior to study product administration.
Participant who is pregnant or breastfeeding.