Trial NCT04444674, PACTR202006922165132
Publication Madhi S, Lancet HIV, 2021
Dates: 2020-08-17 to 2020-11-12
Funding: Public/non profit (The Bill & Melinda Gates Foundation, South African Medical Research Council, UK Research and Innovation, UK National Institute for Health Research)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / South Africa
Follow-up duration (months): 2
• ChAdOx1 nCoV-19 (n = 52)
• Placebo (n = 52)
Inclusion criteria
  • 18–65 years
  • People living with HIV-1 (PLWH) in receipt of antiretroviral treatment for ≥3 months and an HIV-1 viral load <1000 copies/mL within 2 weeks of randomization
  • test seronegative for hepatitis B surface antigen
Exclusion criteria
  • Grade ≥2 abnormalities in full blood count, urea and electrolytes tests, or liver function tests, according to the Division of AIDS Grading Criteria
Interventions
Intervention
2 IM doses of 5x10^10 vp, 28 days apart
Control
2 IM doses, 28 days apart
Participants
Randomized
104 participants
Characteristics of participants
Type of participants: People living with HIV
N=104
27 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 103
Mean age:
Age range: NR
Description of participants
Adults living with HIV in 7 centers in South Africa
Primary outcome
In the register
1) Incidence of adverse events (intervention-related and intervention-unrelated) [Time Frame: Up to 12 months post enrollment]; 2) Cellular Immunogenicity [Time Frame: Up to 12 months post enrollment]; 3) Humoral immunogenicity [Time Frame: Up to 12 months post enrollment]
In the report
Local and systemic reactogenicity and adverse events for 7 and 28 days following vaccination; cellular and humoral immunogenicity of ChAdOx1 nCoV-19, as assessed by quantification of serum antibody (IgG) to SARS-CoV-2 full-length spike (FLS) protein, receptor-binding domain (RBD), and virus neutralizing antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus for 7 days after receipt of vaccine
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes, within one year of completion of the study
Data accessibility: The data accumulated from this study will be stored at RMPRU/ Wits (corresponding author: Professor Shabir A. Madhi E-mail: madhis@rmpru.co.za)
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Low
General comment In addition to the published article, the trial registry (dated June 23, 2020), protocol, statistical analysis plan and supplementary appendix were used in data extraction and assessment of risk of bias. The study reports an interim sub-analysis in people living with HIV of the COV005 trial, for which follow-up is ongoing.
This trial was updated on October 11th 2021, after study publication.