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

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date pushed from Sep 5, 2026 to Sep 26, 2026
  2. Minor Re-verified, no change to tracked fields
  3. Minor Re-verified, no change to tracked fields
  4. Minor Start date pushed from Aug 15, 2026 to Sep 5, 2026 Eligibility criteria expanded, about 23 words · Study description revised · Site details revised at 1 of 4 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Study description revised
    • Site details revised at 1 of 4 sites
  5. Minor 3 versions Re-verified since Aug 27, 2026, no change to tracked fieldsv8-v10
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Site contacts updated at 4 of 4 sitesv7
  2. Minor 2 versions Re-verified since Aug 6, 2026, no change to tracked fieldsv5-v6
  1. Minor Trial sites expanded: 0 → 4 locationsv4
  2. Minor 2 versions Re-verified since Jul 16, 2026, no change to tracked fieldsv2-v3
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07703475
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions COVID -19
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov