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Efficacy Study of COVID-19 mR...

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

Last Updated: 2025-11-26

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

14237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-04-19

Brief Summary

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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.

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Detailed Description

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The study is constructed to help inform which vaccine regimen, likely in combination with enhanced HIV care, could serve as a public health model for an effective and cost-efficient approach to preventing SARS-CoV-2 disease, prolonged viral shedding, and the emergence of VOCs within this population. Moreover, we will evaluate whether immune responses postvaccination can be correlated to these clinically important outcomes.

The study will enroll 15,600 adults from many clinics in Eastern and Southern Africa. All participants in the study will get the study vaccine. There are 4 primary groups in this study. The groups differ in the number of doses of the study vaccine administered. The groups are organized by whether or not people are living with HIV and whether or not people have evidence of prior SARS-CoV-2 infection in their blood.

Group 1 includes people living with HIV and Group 3 includes people who are not living with HIV. All people in groups 1 and 3 will have no evidence of prior SARS-CoV-2 infection in their blood. Participants in Group 1 or Group 3 will get three doses of the study vaccine.

Group 2 includes people living with HIV and Group 4 includes people who are not living with HIV. All people in groups 2 and 4 will have evidence of prior SARS-CoV-2 infection in their blood. Participants in Group 2 or Group 4 will get two doses of the study vaccine.

There are 8 scheduled clinic visits over 18 months. Study visits may include physical examinations, medical history, vaccine injections, HIV testing, blood collection, nasal swabs, and questionnaires.

Conditions

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SARS-CoV-2 Infection HIV Infections COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Study Group 1

COVID-19 mRNA vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Months 0, 1, and 6 among adults living with HIV who are SARS-CoV-2 negative at baseline.

Group Type EXPERIMENTAL

Moderna mRNA-1273

Intervention Type BIOLOGICAL

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).

Moderna mRNA-1273.222

Intervention Type BIOLOGICAL

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).

Vaccine 3 Dose

Intervention Type BIOLOGICAL

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

Study Group 2

COVID-19 mRNA vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Months 0 and 6 among adults living with HIV who are SARS-CoV-2 positive at baseline.

Group Type EXPERIMENTAL

Moderna mRNA-1273

Intervention Type BIOLOGICAL

Moderna mRNA-1273.222

Intervention Type BIOLOGICAL

Vaccine 2 Dose

Intervention Type BIOLOGICAL

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

Study Group 3

COVID-19 mRNA vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Months 0, 1, and 6 among HIV negative adults who are SARS-CoV-2 negative at baseline.

Group Type EXPERIMENTAL

Moderna mRNA-1273

Intervention Type BIOLOGICAL

Moderna mRNA-1273.222

Intervention Type BIOLOGICAL

Vaccine 3 Dose

Intervention Type BIOLOGICAL

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

Study Group 4

COVID-19 mRNA vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Months 0 and 6 among HIV negative adults who are SARS-CoV-2 positive at baseline.

Group Type EXPERIMENTAL

Moderna mRNA-1273

Intervention Type BIOLOGICAL

Moderna mRNA-1273.222

Intervention Type BIOLOGICAL

Vaccine 2 Dose

Intervention Type BIOLOGICAL

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

Monovalent

mRNA-1273 vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Month 6.

Group Type EXPERIMENTAL

Moderna mRNA-1273

Intervention Type BIOLOGICAL

Bivalent

mRNA-1273.222 vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Month 6.

Group Type EXPERIMENTAL

Moderna mRNA-1273.222

Intervention Type BIOLOGICAL

Interventions

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Moderna mRNA-1273

Intervention Type BIOLOGICAL

Moderna mRNA-1273.222

Intervention Type 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.

Intervention Type BIOLOGICAL

Vaccine 2 Dose

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

General and Demographic Criteria

1. Age ≥ 18 years if participant self-reports living with HIV or another comorbidity known to be associated with severe COVID-19, for example (CDC.gov for exhaustive list):

* Hypertension
* Type 2 diabetes mellitus
* Overweight, obese, or severely obese (ie, body mass index \[BMI\] ≥ 25 kg/m2)
* Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
* Chronic kidney disease
* COPD (chronic obstructive pulmonary disease)
* Cancer
* Non-HIV immunocompromised state (weakened immune system) or solid organ transplant
* Pregnancy
* Sickle cell disease
* Smoking
2. Willingness to be followed and remain in the catchment area for the planned duration of the study.
3. Ability and willingness to provide informed consent.
4. Willingness to discuss HIV infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize HIV acquisition/improve HIV care as appropriate based on their infection status.
5. Assessment of Understanding (AoU): Participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly.
6. Agrees not to enroll in another interventional study of an investigational research agent until after the study is completed and all the data has been obtained. Enrollment in studies of investigational research agents for the treatment of COVID-19 is allowed for participants who develop COVID-19 disease.

Exclusion Criteria

General

1. Acutely ill 72 hours prior to or at screening. Participants meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator.
2. History of angioedema or anaphylaxis.

Vaccines and other injections
3. Prior receipt of a SARS-CoV-2 vaccine.
4. History of severe allergic reaction to any ingredient of this vaccine (lipids (SM-102, polyethylene glycol \[PEG\] 2000 dimyristoyl glycerol \[DMG\], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine \[DSPC\]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose).
5. Live attenuated vaccines received within 30 days before first vaccination (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine, live attenuated zoster vaccine).
6. Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, human papilloma virus (HPV), pneumococcal, Hepatitis A or B).
7. Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nigel Garrett

Role: STUDY_CHAIR

Centre for the AIDS Programme of Research in South Africa (CAPRISA)

Philip Kotze

Role: STUDY_CHAIR

Qhakaza Mbokodo Research Clinic

Sufia Dadabhai

Role: STUDY_CHAIR

Blantyre CRS / Johns Hopkins Research Project

Nyaradzo Mgodi

Role: STUDY_CHAIR

University of Zimbabwe Clinical Trials Research Centre

Locations

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Gaborone CRS

Gaborone, , Botswana

Site Status

Eswatini Prevention Center CRS

Mbabane, Hhohho Region, Eswatini

Site Status

Moi University Clinical Research Centre

Eldoret, , Kenya

Site Status

Kisumu - Kombewa CRS

Kisumu, , Kenya

Site Status

Kisumu Crs

Kisumu, , Kenya

Site Status

Blantyre CRS

Blantyre, , Malawi

Site Status

Malawi CRS

Lilongwe, , Malawi

Site Status

Synergy Biomed Research Institute

East London, Eastern Cape, South Africa

Site Status

Nelson Mandela Academic Research Unit CRS

Mthatha, Eastern Cape, South Africa

Site Status

PHOENIX Pharma (Pty) Ltd

Port Elizabeth, Eastern Cape, South Africa

Site Status

Josha Resarch CRS

Bloemfontein, Free State, South Africa

Site Status

MeCRU CRS

Ga-Rankuwa, Gauteng, South Africa

Site Status

Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS

Johannesburg, Gauteng, South Africa

Site Status

Newtown Clinical Research

Johannesburg, Gauteng, South Africa

Site Status

Soweto - Bara CRS

Johannesburg, Gauteng, South Africa

Site Status

Wits RHI Ward 21 CRS

Johannesburg, Gauteng, South Africa

Site Status

MERC Kempton Park

Pretoria, Gauteng, South Africa

Site Status

Synexus Stanza Clinical Research Centre (CRS)

Pretoria, Gauteng, South Africa

Site Status

Tembisa Clinic 4 CoVPN CRS

Tembisa, Gauteng, South Africa

Site Status

CAPRISA eThekwini CRS

Durban, KwaZulu-Natal, South Africa

Site Status

Tongaat CRS

Durban, KwaZulu-Natal, South Africa

Site Status

Vulindlela CRS

Durban, KwaZulu-Natal, South Africa

Site Status

Isipingo CRS

Isipingo, KwaZulu-Natal, South Africa

Site Status

Qhakaza Mbokodo Research Clinic CRS

Ladysmith, KwaZulu-Natal, South Africa

Site Status

MERC Middelburg

Middelburg, Mpumalanga, South Africa

Site Status

Aurum Institute Klerksdorp CRS

Klerksdorp, North West, South Africa

Site Status