Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
2000

Summary

Conditions
Coronavirus
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Four groups will be enrolled to receive either one or two doses of investigational vaccine or placebo. Follow up intensity and blood draws differ between groupsMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blinded, placebo controlled. Pharmacist and vaccine administrators will be unblinded only. DSMB will be unblinded if required to assess safety signalPrimary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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; safet...

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.

Tracking Information

NCT #
NCT04444674
Collaborators
  • Medical Research Council, South Africa
  • Bill and Melinda Gates Foundation
  • Wits Health Consortium (Pty) Ltd
  • University of Witwatersrand, South Africa
Investigators
Principal Investigator: Shabir A Madhi, MD, PhD University of Witwatersrand, South Africa
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