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

NCT07703475 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

  • COVID -19

Interventions

BIOLOGICAL

RVX-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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2027-11-15
Completion
2027-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703475 on ClinicalTrials.gov