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Major study tests moderna vaccine in High-Risk groups

NCT ID NCT05168813

Vaccine Sponsor: COVID-19 Prevention Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large study tested Moderna's COVID-19 mRNA vaccine in over 14,000 people living with HIV or other conditions that increase the risk of severe COVID-19. The goal was to see how well different vaccine doses prevent COVID-19. Participants received either the original or an updated bivalent vaccine, and researchers tracked infections and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Moderna COVID-19 mRNA vaccine (mRNA-1273 and bivalent mRNA-1273.222)
What this could lead to
If successful, this could show that the Moderna COVID-19 vaccine works well in people with HIV or other conditions that raise their risk of severe COVID-19.
What could go wrong
This trial is already completed, so results are available. However, the vaccine may be less effective against new variants, and side effects like fever or fatigue can occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

14,237 people

The number who actually took part.

Started

Dec 2021

Finished

Apr 2024

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 HIV infections SARS CoV 2 infection

Contacts and locations

Locations

  • Aurum Institute Klerksdorp CRS

    Klerksdorp, North West, South Africa

  • Baylor-Uganda CRS

    Kampala, Uganda

  • Blantyre CRS

    Blantyre, Malawi

  • CAPRISA eThekwini CRS

    Durban, KwaZulu-Natal, South Africa

  • Cfhrz Crs

    Lusaka, Zambia

  • Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS

    Johannesburg, Gauteng, South Africa

  • Emavundleni CRS

    Cape Town, Western Cape, South Africa

  • Eswatini Prevention Center CRS

    Mbabane, Hhohho Region, Eswatini

  • FAM-CRU (Family Clinical Research Unit)

    Cape Town, Western Cape, South Africa

  • Gaborone CRS

    Gaborone, Botswana

  • Groote Schuur HIV CRS

    Cape Town, Western Cape, South Africa

  • Isipingo CRS

    Isipingo, KwaZulu-Natal, South Africa

  • Joint Clinical Research Centre

    Kampala, Uganda

  • Josha Resarch CRS

    Bloemfontein, Free State, South Africa

  • Kisumu - Kombewa CRS

    Kisumu, 40100, Kenya

  • Kisumu Crs

    Kisumu, Kenya

  • Kliptown Soweto CRS

    Johannesburg, South Africa

  • MERC Kempton Park

    Pretoria, Gauteng, South Africa

  • MERC Middelburg

    Middelburg, Mpumalanga, South Africa

  • MERC Welkom

    Welkom, South Africa

  • MU-JHU Research Collaboration CRS

    Kampala, Uganda

  • Malawi CRS

    Lilongwe, Malawi

  • Masiphumelele Clinical Research Site (MASI) CRS

    Cape Town, Western Cape, South Africa

  • Matero Reference Clinic CRS

    Lusaka, Zambia

  • MeCRU CRS

    Ga-Rankuwa, Gauteng, South Africa

  • Moi University Clinical Research Centre

    Eldoret, Kenya

  • Ndlovu Research Centre CoVPN CRS

    Elandsdoorn, South Africa

  • Nelson Mandela Academic Research Unit CRS

    Mthatha, Eastern Cape, South Africa

  • Newtown Clinical Research

    Johannesburg, Gauteng, South Africa

  • PHOENIX Pharma (Pty) Ltd

    Port Elizabeth, Eastern Cape, South Africa

  • PHRU Matlosana CRS

    Klerksdorp, South Africa

  • Qhakaza Mbokodo Research Clinic CRS

    Ladysmith, KwaZulu-Natal, South Africa

  • Rustenburg CRS

    Rustenburg, North West, South Africa

  • Soweto - Bara CRS

    Johannesburg, Gauteng, South Africa

  • Synergy Biomed Research Institute

    East London, Eastern Cape, South Africa

  • Synexus Helderberg

    Stellenbosch, Western Cape, South Africa

  • Synexus Stanza Clinical Research Centre (CRS)

    Pretoria, Gauteng, South Africa

  • TASK Central

    Cape Town, Western Cape, South Africa

  • TASK Eden

    George, Western Cape, South Africa

  • Tembisa Clinic 4 CoVPN CRS

    Tembisa, Gauteng, South Africa

  • Tongaat CRS

    Durban, KwaZulu-Natal, South Africa

  • UNC Global Projects / Kamwala District Health Centre

    Lusaka, Zambia

  • UVRI-IAVI HIV Vaccine Program LTD. CRS

    Entebbe, Uganda

  • Univeristy of Cape Town Lung CRS Institute

    Cape Town, Western Cape, South Africa

  • Vulindlela CRS

    Durban, KwaZulu-Natal, South Africa

  • Wits RHI Ward 21 CRS

    Johannesburg, Gauteng, South Africa

  • Zambia Emory HIV Research Project - Ndola CoVPN CRS

    Ndola, Zambia

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