A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults

Part of paid clinical trials in Decatur, Georgia.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07536308
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • OCU500 — BIOLOGICAL
    OCU500 is a monovalent, replication-defective, chimpanzee adenovirus (ChAd36)-vectored COVID-19 vaccine that encodes a codon-optimized, stabilized prefusion form of the spike (S) protein from the Omicron XBB1.5 strain.

Study Details

This phase 1 randomized, open-label, dose-escalation clinical trial evaluates the safety and immunogenicity of OCU500, a ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine, in healthy adults aged 18-64 who previously completed a primary COVID-19 vaccination series and at least one booster. The study evaluates two dose levels (1×10\^10 viral particles (VP) and 5×10\^10 VP) and two routes of administration (intranasal and inhaled). The trial includes 80 participants across four study arms (20 per arm). The primary objective is to evaluate the safety and reactogenicity of a single dose of OCU500 administered in previously vaccinated healthy adults.

Key Dates

Start date
May 4, 2026
Status verified
Apr 2026
Primary completion
Apr 29, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm 1
    A single dose of 1×10\^10 viral particles (VP) in 100 uL of OCU500 administered via inhalation on Day 1 in participants from 18 to 64 years of age. N = 20
  • Experimental: Arm 2
    A single dose of 1×10\^10 viral particles (VP) in 100 uL of OCU500 administered intranasally (0.05 mL/nostril) on Day 1 in participants from 18 to 64 years of age. N = 20
  • Experimental: Arm 3
    A single dose of 5x10\^10 viral particles (VP) in 100 uL of OCU500 administered via inhalation on Day 1 in participants from 18 to 64 years of age. N = 20
  • Experimental: Arm 4
    A single dose of 5x10\^10 viral particles (VP) in 100 uL of OCU500 administered intranasally (0.05 mL/nostril) on Day 1 in participants from 18 to 64 years of age. N = 20

Primary Outcome Measure

Occurrence of abnormal clinical safety laboratory adverse events (AE). [ Time Frame: Through Day 8 ]

Locations (6)

FacilityCityStateZIPSite coordinators
The Hope Clinic of Emory UniversityDecaturGeorgia30030-1705
Site Recruitment Contact
[email protected]
404-712-1371
University of Maryland, School of Medicine, Center for Vaccine Development and Global HealthBaltimoreMaryland21201-1509
Site Recruitment Contact
[email protected]
410-706-8800
Brigham and Women's HospitalBostonMassachusetts02115-6110
Site Recruitment Contact
[email protected]
617-525-7327
Saint Louis University Center for Vaccine DevelopmentSt LouisMissouri63104-1015
Site Recruitment Contact
[email protected]
314-977-6333
Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research UnitSt LouisMissouri63110-
University of Texas Medical BranchGalvestonTexas77555-0435
Site Recruitment Contact
[email protected]
409-772-5278

Find similar trials in Decatur, GA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
The Hope Clinic of Emory University· Decatur, GAUniversity of Maryland, School of Medicine, Center for Vaccine Development and Global Health· Baltimore, MDBrigham and Women's Hospital· Boston, MASaint Louis University Center for Vaccine Development· St Louis, MOWashington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit· St Louis, MOUniversity of Texas Medical Branch· Galveston, TX

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