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Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

NCT05168813 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 14237

Last updated 2026-04-21

Study results available
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Summary

The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.

Conditions

Interventions

BIOLOGICAL

Moderna mRNA-1273

COVID-19 vaccine (mRNA-1273) developed by Moderna, Inc. is a lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available).

BIOLOGICAL

Moderna mRNA-1273.222

COVID-19 vaccine (mRNA-1273.222) developed by Moderna, Inc. is an updated bivalent version of Moderna's mRNA-1273 vaccine, composed of equal parts of mRNA-1273 and mRNA that encodes the S protein of the Omicron subvariants BA.4/.5 (which have the same S protein).

BIOLOGICAL

Vaccine 3 Dose

COVID-19 mRNA vaccine in 100 mcg dose given as IM injection into the deltoid muscle on Months 0, 1, and 6.

BIOLOGICAL

Vaccine 2 Dose

COVID-19 mRNA vaccine is to be administered as IM injection into the deltoid muscle on Months 0 and 6.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Medical Research Council, South Africa

    collaborator OTHER

  • COVID-19 Prevention Network

    lead NETWORK

Principal Investigators

  • Nigel Garrett · Centre for the AIDS Programme of Research in South Africa (CAPRISA)

  • Philip Kotze · Qhakaza Mbokodo Research Clinic

  • Sufia Dadabhai · Blantyre CRS / Johns Hopkins Research Project

  • Nyaradzo Mgodi · University of Zimbabwe Clinical Trials Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-04-19
Completion
2024-04-19
FDA Drug
Yes

Countries

  • Botswana
  • Eswatini
  • Kenya
  • Malawi
  • South Africa
  • Uganda
  • Zambia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05168813 on ClinicalTrials.gov