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

Conditions

• COVID -19

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Accepted

Interventions

• RVX-sCPD9 — BIOLOGICAL
  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.

Study Details

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.

Key Dates

First listed

Jul 14, 2026

Start date

Sep 5, 2026

Status verified

Jul 2026

Primary completion

Nov 15, 2027

Completion

Nov 15, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Arm 1
  Healthy adults will receive a single dose of 1x10\^2 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20
• Experimental: Arm 2
  Healthy adults will receive a single dose of 1x10\^3 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20
• Experimental: Arm 3
  Healthy adults will receive a single dose of 1x10\^4 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20
• Experimental: Arm 4
  Healthy adults will receive a single dose of 5x10\^4 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20

Primary Outcome Measure

Occurrence of abnormal clinical safety laboratory adverse events (AEs) [ Time Frame: Through Day 15 ]

Locations (4)

Find similar trials in New York, NY

Related Studies

• A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
  PHASE1 · Recruiting · ModeX Therapeutics, An OPKO Health Company · Las Vegas, Nevada
• Preparedness Through Respiratory Virus Epidemiology and Community Engagement
  Recruiting · University of California, San Diego · La Jolla, California
• Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home/Non-Laboratory Settings
  Not Yet Recruiting · Aptitude Medical Systems · Trussville, Alabama