Clinical trial NCT04444674: COVID-19 Vaccine (ChAdOx1 nCoV-19) Trial in South African Adults With and Without HIV-infection
Official title: 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
Conditions: Coronavirus
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.
Interventions:
description: Dose of 5-7.5x10^10vp of ChAdOx1 nCoV-19
name: ChAdOx1 nCoV-19
type: Biological
description: Normal saline 0.9% as placebo
name: Normal saline 0.9%
type: Biological
Study arms:
design_group_description: Participants (HIV-negative) will receive two doses of 5-7.5x10^10 vp ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart. Participants, investigators and outcome assessors will be blinded to intervention. Participants will have 11 routine visits over a 12 month period.
design_group_title: Group 1- IP
design_group_type: Experimental
design_group_description: Participants (HIV-negative) will receive two doses of Normal saline (0.9%) in deltoid of non-dominant arm, 28 days apart. Participants, investigators and outcome assessors will be blinded to intervention. Participants will have 11 routine visits over a 12 month period.
design_group_title: Group 1- placebo
design_group_type: Placebo Comparator
design_group_description: Participants (HIV-negative) will receive two doses of 5-7.5x10^10 vp ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart. Participants, investigators and outcome assessors will be blinded to intervention. Participants will have 7 (1-dose) or 9 (2 doses) routine visits over a 12 month period.
design_group_title: Group 2a- IP
design_group_type: Experimental
design_group_description: Participants (HIV-negative) will receive two doses of placebo in deltoid of non-dominant arm, 28 days apart. Participants, investigators and outcome assessors will be blinded to intervention. Participants will have 7 (1-dose) or 9 (2 doses) routine visits over a 12 month period.
design_group_title: Group 2a- placebo
design_group_type: Placebo Comparator
design_group_description: Participants will receive two doses of 5-7.5x10^10 vp ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart. Participants, investigators and outcome assessors will be blinded to intervention. Participants will have 5 (1-dose) or 6 (2 doses) routine visits over a 12 month period.
design_group_title: Group 2b- IP
design_group_type: Experimental
design_group_description: Participants will receive two doses of placebo in deltoid of non-dominant arm, 28 days apart. Participants, investigators and outcome assessors will be blinded to intervention. Participants will have 5 (1-dose) or 6 (2 doses) routine visits over a 12 month period.
design_group_title: Group 2b- placebo
design_group_type: Placebo Comparator
design_group_description: Participants (HIV-positive) will receive two doses of 5-7.5x10^10 vp ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart. Participants, investigators and outcome assessors will be blinded to intervention. Participants will have 11 routine visits over a 12 month period.
design_group_title: Group 3- IP
design_group_type: Experimental
design_group_description: Participants (HIV-positive) will receive two doses of placebo in deltoid of non-dominant arm, 28 days apart. Participants, investigators and outcome assessors will be blinded to intervention. Participants will have 11 routine visits over a 12 month period.
design_group_title: Group 3- placebo
design_group_type: Placebo Comparator
Sponsor: University of Oxford
Collaborators: Gates Foundation (United States)
The Medical Research Council
Wits Health Consortium
University of the Witwatersrand
Drug name mappings:
name: COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)
lang: EN
name: コロナウイルス（SARS-CoV-2）ワクチン（遺伝子組換えサルアデノウイルスベクター）(AstraZeneca Plc)
lang: JP