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…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Provides written informed consent before initiation of any study procedures. 2. Able to understand and agree to comply with planned study procedures and be available for all study visits. 3. Non-pregnant adults, 18 through 64 years of age at the time of study product administration. 4. Participants of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least one acceptable primary form of contraception\*\*\*. \*These criteria apply to females who are in a heterosexual relationship who are of childbearing potential. Not of child…
Interventions
- BiologicalRVX-sCPD9
RVX-sCPD9 is a live-attenuated SARS-CoV-2 vaccine candidate engineered from the ancestral B.1 strain for intranasal administration to prevent coronavirus disease 2019 (COVID-19) and reduce viral transmission. The vaccine was generated through two complementary attenuation strategies: a codon-pair-deoptimization of the viral genome that reduced viral fitness while preserving protein amino acid sequence, and a deletion of the spike furin cleavage site (FCS), a modification known to prevent horizontal transmission and further attenuate pathogenicity.
Locations (4)
- New York University School of Medicine - Langone Medical Center - Vaccine CenterNew York, New York
- Duke Vaccine and Trials UnitDurham, North Carolina
- Cincinnati Children's Hospital Medical Center Vaccine Research CenterCincinnati, Ohio
- Baylor College of MedicineHouston, Texas