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

NCT04444674 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2130

Last updated 2020-11-27

No results posted yet for this study

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.

Conditions

  • Coronavirus

Interventions

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

Sponsors & Collaborators

  • Medical Research Council, South Africa

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Wits Health Consortium (Pty) Ltd

    collaborator OTHER

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Shabir A Madhi, MD, PhD · University of Witwatersrand, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04444674 on ClinicalTrials.gov