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.
Sequential
RVX-sCPD9
Biological/VaccineRVX-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.
Occurrence of abnormal clinical safety laboratory adverse events (AEs)
Occurrence of Adverse Events of Special Interest (AESIs)
Occurrence of Medically-Attended Adverse Events (MAAEs)
Occurrence of solicited local adverse events (AEs)
Nasal mucosal Immunoglobulin A (IgA) anti-S binding antibodies
Nasal mucosal Immunoglobulin G (IgG) anti-S binding antibodies
Serum anti-S binding Immunoglobulin A (IgA) antibodies
Serum anti-S binding Immunoglobulin G (IgG) antibodies
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This trial is not recruiting at the moment. You can still explore other options: