Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of a Prophylactic COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults (ProVIVA-SA-1)
Overview
- Phase
- Phase 1
- Intervention
- hAd5-S-Fusion+N-ETSD vaccine
- Conditions
- Covid19
- Sponsor
- ImmunityBio, Inc.
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Number of Participants With Medically Attended Adverse Events (MAAE)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •A history of illness compatible with COVID-19 disease since March
- •Serious adverse reaction to any vaccine, any unrelated medication or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past.
- •Pregnant or breastfeeding women.
- •Live in a nursing home or long-term care facility.
- •Chronic lung disease or moderate to severe asthma.
- •Bone marrow or organ transplantation recipients.
- •Chronic kidney disease undergoing dialysis.
- •Liver disease.
- •Any disease associated with acute fever, or any infection.
- •Self-reported history of severe acute respiratory syndrome (SARS).
Arms & Interventions
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose
hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22
Intervention: hAd5-S-Fusion+N-ETSD vaccine
Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose
hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22
Intervention: hAd5-S-Fusion+N-ETSD vaccine
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose
hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1
Intervention: hAd5-S-Fusion+N-ETSD vaccine
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per dose
hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1
Intervention: hAd5-S-Fusion+N-ETSD vaccine
Outcomes
Primary Outcomes
Number of Participants With Medically Attended Adverse Events (MAAE)
Time Frame: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants with MAAEs through 6 months post final vaccine administration
Number of Participants With Solicited Local Reactogenicity AEs
Time Frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration
Number of Participants With Solicited Systemic Reactogenicity AEs
Time Frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Number of Participants With Unsolicited AEs
Time Frame: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants with unsolicited AEs through 6 months post final vaccine administration