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

Phase 2
Completed
Conditions
COVID-19
SARS-CoV-2 Infection
HIV Infections
Interventions
Biological: Moderna mRNA-1273
Biological: Vaccine 3 Dose
Biological: Vaccine 2 Dose
Registration Number
NCT05168813
Lead Sponsor
COVID-19 Prevention Network
Brief 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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
14232
Inclusion Criteria

General and Demographic Criteria

  1. Age β‰₯ 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] β‰₯ 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.

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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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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 3Moderna mRNA-1273This arm will assess the relative vaccine efficacy (RVE) of a 3- vs. 2-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed, symptomatic COVID-19 in HIV negative adults who are SARS-CoV-2 negative at baseline.
Group 4Moderna mRNA-1273This arm will assess the relative vaccine efficacy (RVE) of a 2- vs. 1-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed symptomatic COVID-19 in HIV negative adults who are SARSCoV-2 positive at baseline.
Group 1Moderna mRNA-1273This arm will assess the relative vaccine efficacy (RVE) of a 3- vs. 2-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed, symptomatic COVID-19 in adult people living with HIV who are SARS-CoV-2 negative at baseline.
Group 1Vaccine 3 DoseThis arm will assess the relative vaccine efficacy (RVE) of a 3- vs. 2-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed, symptomatic COVID-19 in adult people living with HIV who are SARS-CoV-2 negative at baseline.
Group 2Vaccine 2 DoseThis arm will assess the relative vaccine efficacy (RVE) of a 2- vs. 1-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed symptomatic COVID-19 in adult people living with HIV who are SARS-CoV-2 positive at baseline.
Group 4Vaccine 2 DoseThis arm will assess the relative vaccine efficacy (RVE) of a 2- vs. 1-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed symptomatic COVID-19 in HIV negative adults who are SARSCoV-2 positive at baseline.
Group 3Vaccine 3 DoseThis arm will assess the relative vaccine efficacy (RVE) of a 3- vs. 2-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed, symptomatic COVID-19 in HIV negative adults who are SARS-CoV-2 negative at baseline.
Group 2Moderna mRNA-1273This arm will assess the relative vaccine efficacy (RVE) of a 2- vs. 1-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed symptomatic COVID-19 in adult people living with HIV who are SARS-CoV-2 positive at baseline.
Primary Outcome Measures
NameTimeMethod
Number of Adverse eventsMeasured both pre-Month 6 and post-Month 6 stages

Positive result of acute SARS-CoV-2 infection assessed by nucleic acid amplification testing (NAAT) of a nasal swab, plus clinical signs indicative of severe systemic illness or respiratory failure; or Acute Respiratory Distress Syndrome (ARDS); or significant acute renal, hepatic or neurologic dysfunction; or admission to an intensive care unit or death

Positive result of acute SARS-CoV-2 infectionMeasured least 14 days after the Month 6 dose, through study completion, an average of 1 year

Assessed by nucleic acid amplification testing (NAAT) of a nasal swab, plus clinical signs indicative of severe systemic illness or respiratory failure; or Acute Respiratory Distress Syndrome (ARDS); or significant acute renal, hepatic or neurologic dysfunction; or admission to an intensive care unit or death

Positive result of Severe COVID-19Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year

Assessed by nucleic acid amplification testing (NAAT) of a nasal swab, plus clinical signs indicative of severe systemic illness or respiratory failure; or Acute Respiratory Distress Syndrome (ARDS); or significant acute renal, hepatic or neurologic dysfunction; or admission to an intensive care unit or death

Secondary Outcome Measures
NameTimeMethod
Number of SARS-CoV-2 infectionThrough study completion after Dose 1 vaccination, an average of 1 year

Viral whole genome sequences

Positive result of acute and severe SARS-CoV-2 infectionMeasured at starting 1 day after dose 1, 14 days after the last dose before Month 6 dose, or 14 days after Month 6 dose through study completion, an average of 1 year

SARS-CoV-2 infection diagnosed by seroconversion in the absence of symptoms

Trial Locations

Locations (47)

Gaborone CRS

πŸ‡§πŸ‡Ό

Gaborone, Botswana

Synergy Biomed Research Institute

πŸ‡ΏπŸ‡¦

East London, Eastern Cape, South Africa

Nelson Mandela Academic Research Unit CRS

πŸ‡ΏπŸ‡¦

Mthatha, Eastern Cape, South Africa

Rustenburg CRS

πŸ‡ΏπŸ‡¦

Rustenburg, North West, South Africa

Synexus Helderberg

πŸ‡ΏπŸ‡¦

Stellenbosch, Western Cape, South Africa

Eswatini Prevention Center CRS

πŸ‡ΈπŸ‡Ώ

Mbabane, Hhohho, Swaziland

UNC Global Projects / Kamwala District Health Centre

πŸ‡ΏπŸ‡²

Lusaka, Zambia

Zambia Emory HIV Research Project - Ndola CoVPN CRS

πŸ‡ΏπŸ‡²

Ndola, Zambia

UVRI-IAVI HIV Vaccine Program LTD. CRS

πŸ‡ΊπŸ‡¬

Entebbe, Uganda

Malawi CRS

πŸ‡²πŸ‡Ό

Lilongwe, Malawi

Joint Clinical Research Centre

πŸ‡ΊπŸ‡¬

Kampala, Uganda

Blantyre CRS

πŸ‡²πŸ‡Ό

Blantyre, Malawi

Tongaat CRS

πŸ‡ΏπŸ‡¦

Durban, KwaZulu-Natal, South Africa

Vulindlela CRS

πŸ‡ΏπŸ‡¦

Durban, KwaZulu-Natal, South Africa

Isipingo CRS

πŸ‡ΏπŸ‡¦

Isipingo, KwaZulu-Natal, South Africa

Wits RHI Ward 21 CRS

πŸ‡ΏπŸ‡¦

Johannesburg, Gauteng, South Africa

TASK Eden

πŸ‡ΏπŸ‡¦

George, Western Cape, South Africa

Cfhrz Crs

πŸ‡ΏπŸ‡²

Lusaka, Zambia

Baylor-Uganda CRS

πŸ‡ΊπŸ‡¬

Kampala, Uganda

PHRU Matlosana CRS

πŸ‡ΏπŸ‡¦

Klerksdorp, South Africa

Kisumu - Kombewa CRS

πŸ‡°πŸ‡ͺ

Kisumu, Kenya

Moi University Clinical Research Centre

πŸ‡°πŸ‡ͺ

Eldoret, Kenya

Kisumu Crs

πŸ‡°πŸ‡ͺ

Kisumu, Kenya

PHOENIX Pharma (Pty) Ltd

πŸ‡ΏπŸ‡¦

Port Elizabeth, Eastern Cape, South Africa

Josha Resarch CRS

πŸ‡ΏπŸ‡¦

Bloemfontein, Free State, South Africa

MeCRU CRS

πŸ‡ΏπŸ‡¦

Ga-Rankuwa, Gauteng, South Africa

Newtown Clinical Research

πŸ‡ΏπŸ‡¦

Johannesburg, Gauteng, South Africa

Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS

πŸ‡ΏπŸ‡¦

Johannesburg, Gauteng, South Africa

Soweto - Bara CRS

πŸ‡ΏπŸ‡¦

Johannesburg, Gauteng, South Africa

Synexus Stanza Clinical Research Centre (CRS)

πŸ‡ΏπŸ‡¦

Pretoria, Gauteng, South Africa

MERC Kempton Park

πŸ‡ΏπŸ‡¦

Pretoria, Gauteng, South Africa

CAPRISA eThekwini CRS

πŸ‡ΏπŸ‡¦

Durban, KwaZulu-Natal, South Africa

MERC Middelburg

πŸ‡ΏπŸ‡¦

Middelburg, Mpumalanga, South Africa

Qhakaza Mbokodo Research Clinic CRS

πŸ‡ΏπŸ‡¦

Ladysmith, KwaZulu-Natal, South Africa

Aurum Institute Klerksdorp CRS

πŸ‡ΏπŸ‡¦

Klerksdorp, North West, South Africa

Emavundleni CRS

πŸ‡ΏπŸ‡¦

Cape Town, Western Cape, South Africa

FAM-CRU (Family Clinical Research Unit)

πŸ‡ΏπŸ‡¦

Cape Town, Western Cape, South Africa

Groote Schuur HIV CRS

πŸ‡ΏπŸ‡¦

Cape Town, Western Cape, South Africa

Masiphumelele Clinical Research Site (MASI) CRS

πŸ‡ΏπŸ‡¦

Cape Town, Western Cape, South Africa

TASK Central

πŸ‡ΏπŸ‡¦

Cape Town, Western Cape, South Africa

Univeristy of Cape Town Lung CRS Institute

πŸ‡ΏπŸ‡¦

Cape Town, Western Cape, South Africa

Ndlovu Research Centre CoVPN CRS

πŸ‡ΏπŸ‡¦

Elandsdoorn, South Africa

Kliptown Soweto CRS

πŸ‡ΏπŸ‡¦

Johannesburg, South Africa

MERC Welkom

πŸ‡ΏπŸ‡¦

Welkom, South Africa

MU-JHU Research Collaboration CRS

πŸ‡ΊπŸ‡¬

Kampala, Uganda

Matero Reference Clinic CRS

πŸ‡ΏπŸ‡²

Lusaka, Zambia

Tembisa Clinic 4 CoVPN CRS

πŸ‡ΏπŸ‡¦

Tembisa, Gauteng, South Africa

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