NCT04444674

COVID-19 Vaccine (ChAdOx1 nCoV-19) Trial in South African Adults With and Without HIV-infection

An Adaptive Phase I/II Randomized Placebo-controlled Trial to Determine Safety, Immunogenicity and Efficacy of Non-replicating ChAdOx1 SARS-CoV-2 Vaccine in South African Adults Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2,130 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase I/II, double-blinded, placebo-controlled, individually randomized trial to assess safety, immunogenicity and efficacy of the candidate Coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults aged 18-65 years living with and without HIV in South Africa. The vaccine or placebo will be administered via an intramuscular injection into the deltoid muscle of the non-dominant arm.

Detailed description

A total of 2070 participants will be enrolled into the trial; 1970 HIV-uninfected and 100 people living with HIV. There will be 4 trial groups, group 1 (n=50; intensive safety \& immunogenicity cohort, HIV negative), group 2a (n=250; safety, intense immunogenicity \& efficacy), group 2b (n=1650; safety, immunogenicity \& vaccine efficacy) and group 3 (n=100, intensive safety \& immunogenicity cohort, HIV positive). Participants will be followed up for 12 months after enrollment.

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 nCoV-19	Dose of 5-7.5x10\^10vp of ChAdOx1 nCoV-19
BIOLOGICAL	Normal saline 0.9%	Normal saline 0.9% as placebo

Timeline

• Start date: 2020-06-24
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2020-06-23
• Last updated: 2020-11-27

Locations

7 sites across 1 country: South Africa