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Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern (CoVPN3008)

Primary Purpose

SARS-CoV-2 Infection, HIV Infections, COVID-19

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Moderna mRNA-1273
Vaccine 3 Dose
Vaccine 2 Dose
Sponsored by
COVID-19 Prevention Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring SARS-CoV-2, HIV, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gaborone CRS
  • Moi University Clinical Research Centre
  • Kisumu - Kombewa CRS
  • Kisumu Crs
  • Blantyre CRS
  • Malawi CRS
  • Synergy Biomed Research Institute
  • Nelson Mandela Academic Research Unit CRS
  • PHOENIX Pharma (Pty) Ltd
  • Josha Resarch CRS
  • MeCRU CRS
  • Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS
  • Newtown Clinical Research
  • Soweto - Bara CRS
  • Wits RHI Ward 21 CRS
  • MERC Kempton Park
  • Synexus Stanza Clinical Research Centre (CRS)
  • Tembisa Clinic 4 CoVPN CRS
  • CAPRISA eThekwini CRS
  • Tongaat CRS
  • Vulindlela CRS
  • Isipingo CRS
  • Qhakaza Mbokodo Research Clinic CRS
  • MERC Middelburg
  • Aurum Institute Klerksdorp CRS
  • Rustenburg CRS
  • Emavundleni CRS
  • FAM-CRU (Family Clinical Research Unit)
  • Groote Schuur HIV CRS
  • Masiphumelele Clinical Research Site (MASI) CRS
  • TASK Central
  • Univeristy of Cape Town Lung CRS Institute
  • TASK Eden
  • Synexus Helderberg
  • Ndlovu Research Centre CoVPN CRS
  • Kliptown Soweto CRS
  • PHRU Matlosana CRS
  • MERC Welkom
  • Eswatini Prevention Center CRS
  • UVRI-IAVI HIV Vaccine Program LTD. CRS
  • Baylor-Uganda CRS
  • Joint Clinical Research Centre
  • MU-JHU Research Collaboration CRS
  • Cfhrz Crs
  • Matero Reference Clinic CRS
  • UNC Global Projects / Kamwala District Health Centre
  • Zambia Emory HIV Research Project - Ndola CoVPN CRS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

This 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.

This 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.

This 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.

This 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.

Outcomes

Primary Outcome Measures

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 Severe COVID-19
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 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 Severe COVID-19
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
Number of Adverse events
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

Secondary Outcome Measures

Positive result of acute and severe 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 and severe 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 and severe 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 and severe 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 and severe SARS-CoV-2 infection
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
Number of SARS-CoV-2 infection
Measured by neutralization phenotypes and viral genotypic characteristics of SARS-CoV-2 at diagnosis.
Number of SARS-CoV-2 infection
SARS-CoV-2 infection diagnosed by seroconversion throughout the study
Positive result of acute and severe SARS-CoV-2 infection
SARS-CoV-2 infection diagnosed by seroconversion in the absence of symptoms
Number of SARS-CoV-2 infection
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.
Number of SARS-CoV-2 infection
SARS-CoV-2 viral load (as inferred from RT-PCR cycle threshold values)
Number of SARS-CoV-2 infection
Viral whole genome sequences

Full Information

First Posted
December 21, 2021
Last Updated
July 6, 2023
Sponsor
COVID-19 Prevention Network
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT05168813
Brief Title
Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
Acronym
CoVPN3008
Official Title
Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
April 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
COVID-19 Prevention Network
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, HIV Infections, COVID-19
Keywords
SARS-CoV-2, HIV, COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
This 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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
This 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.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
This 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.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
This 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.
Intervention Type
Biological
Intervention Name(s)
Moderna mRNA-1273
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
Vaccine 3 Dose
Intervention Description
COVID-19 mRNA vaccine in 100 mcg dose given as IM injection into the deltoid muscle on Day 1, Day 29, and Day 169.
Intervention Type
Biological
Intervention Name(s)
Vaccine 2 Dose
Intervention Description
COVID-19 mRNA vaccine is to be administered as IM injection into the deltoid muscle on Day 1 and Day 169.
Primary Outcome Measure Information:
Title
Positive result of acute SARS-CoV-2 infection
Description
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
Time Frame
Measured 1 day after Month 0 dose until Month 6 dose
Title
Positive result of Severe COVID-19
Description
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
Time Frame
Measured 1 day after Month 0 dose until Month 6 dose
Title
Positive result of acute SARS-CoV-2 infection
Description
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
Time Frame
Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year
Title
Positive result of Severe COVID-19
Description
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
Time Frame
Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year
Title
Number of Adverse events
Description
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
Time Frame
Measured both pre-Month 6 and post-Month 6 stages
Secondary Outcome Measure Information:
Title
Positive result of acute and severe SARS-CoV-2 infection
Description
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
Time Frame
Measured at least 14 days after the last pre-Month 6 dose until the Month 6 dose
Title
Positive result of acute and severe SARS-CoV-2 infection
Description
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
Time Frame
Measured starting 1 day after dose 1 through 14 days after the last pre-Month 6 dose until the Month 6 dose.
Title
Positive result of acute and severe SARS-CoV-2 infection
Description
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
Time Frame
Measured at least 14 days after Month 6 injection
Title
Positive result of acute and severe SARS-CoV-2 infection
Description
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
Time Frame
Measured at least 14 days after the Month 6 dose, through study completion, an average of 1 year
Title
Positive result of acute and severe SARS-CoV-2 infection
Description
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
Time Frame
Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year
Title
Number of SARS-CoV-2 infection
Description
Measured by neutralization phenotypes and viral genotypic characteristics of SARS-CoV-2 at diagnosis.
Time Frame
Measured at 1 day after dose 1, 14 days after the last pre-Month6 dose , or 14 days after Month 6 dose, through study completion, an average of 1 year
Title
Number of SARS-CoV-2 infection
Description
SARS-CoV-2 infection diagnosed by seroconversion throughout the study
Time Frame
Measured at starting 1 day after dose 1, 14 days after the last pre-Month 6 dose , or 14 days after Month 6 dose, through study completion, an average of 1 year
Title
Positive result of acute and severe SARS-CoV-2 infection
Description
SARS-CoV-2 infection diagnosed by seroconversion in the absence of symptoms
Time Frame
Measured 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
Title
Number of SARS-CoV-2 infection
Description
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.
Time Frame
Measured at starting 1 day after dose 1 or 14 days after the last dose before Month 6 dose through study completion, an average of 1 year
Title
Number of SARS-CoV-2 infection
Description
SARS-CoV-2 viral load (as inferred from RT-PCR cycle threshold values)
Time Frame
Through study completion after Dose 1 vaccination, an average of 1 year
Title
Number of SARS-CoV-2 infection
Description
Viral whole genome sequences
Time Frame
Through study completion after Dose 1 vaccination, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: General and Demographic Criteria 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 Willingness to be followed and remain in the catchment area for the planned duration of the study. Ability and willingness to provide informed consent. 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. 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. 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 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. History of angioedema or anaphylaxis. Vaccines and other injections Prior receipt of a SARS-CoV-2 vaccine. 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). 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). 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). Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Garrett
Organizational Affiliation
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Philip Kotze
Organizational Affiliation
Qhakaza Mbokodo Research Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sufia Dadabhai
Organizational Affiliation
Blantyre CRS / Johns Hopkins Research Project
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nyaradzo Mgodi
Organizational Affiliation
University of Zimbabwe Clinical Trials Research Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Gaborone CRS
City
Gaborone
Country
Botswana
Facility Name
Moi University Clinical Research Centre
City
Eldoret
Country
Kenya
Facility Name
Kisumu - Kombewa CRS
City
Kisumu
ZIP/Postal Code
40100
Country
Kenya
Facility Name
Kisumu Crs
City
Kisumu
Country
Kenya
Facility Name
Blantyre CRS
City
Blantyre
Country
Malawi
Facility Name
Malawi CRS
City
Lilongwe
Country
Malawi
Facility Name
Synergy Biomed Research Institute
City
East London
State/Province
Eastern Cape
Country
South Africa
Facility Name
Nelson Mandela Academic Research Unit CRS
City
Mthatha
State/Province
Eastern Cape
Country
South Africa
Facility Name
PHOENIX Pharma (Pty) Ltd
City
Port Elizabeth
State/Province
Eastern Cape
Country
South Africa
Facility Name
Josha Resarch CRS
City
Bloemfontein
State/Province
Free State
Country
South Africa
Facility Name
MeCRU CRS
City
Ga-Rankuwa
State/Province
Gauteng
Country
South Africa
Facility Name
Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Newtown Clinical Research
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Soweto - Bara CRS
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Wits RHI Ward 21 CRS
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
MERC Kempton Park
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Synexus Stanza Clinical Research Centre (CRS)
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Tembisa Clinic 4 CoVPN CRS
City
Tembisa
State/Province
Gauteng
Country
South Africa
Facility Name
CAPRISA eThekwini CRS
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Tongaat CRS
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Vulindlela CRS
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Isipingo CRS
City
Isipingo
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Qhakaza Mbokodo Research Clinic CRS
City
Ladysmith
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
MERC Middelburg
City
Middelburg
State/Province
Mpumalanga
Country
South Africa
Facility Name
Aurum Institute Klerksdorp CRS
City
Klerksdorp
State/Province
North West
Country
South Africa
Facility Name
Rustenburg CRS
City
Rustenburg
State/Province
North West
Country
South Africa
Facility Name
Emavundleni CRS
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
FAM-CRU (Family Clinical Research Unit)
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Groote Schuur HIV CRS
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Masiphumelele Clinical Research Site (MASI) CRS
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
TASK Central
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Univeristy of Cape Town Lung CRS Institute
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
TASK Eden
City
George
State/Province
Western Cape
Country
South Africa
Facility Name
Synexus Helderberg
City
Stellenbosch
State/Province
Western Cape
Country
South Africa
Facility Name
Ndlovu Research Centre CoVPN CRS
City
Elandsdoorn
Country
South Africa
Facility Name
Kliptown Soweto CRS
City
Johannesburg
Country
South Africa
Facility Name
PHRU Matlosana CRS
City
Klerksdorp
Country
South Africa
Facility Name
MERC Welkom
City
Welkom
Country
South Africa
Facility Name
Eswatini Prevention Center CRS
City
Mbabane
State/Province
Hhohho
Country
Swaziland
Facility Name
UVRI-IAVI HIV Vaccine Program LTD. CRS
City
Entebbe
Country
Uganda
Facility Name
Baylor-Uganda CRS
City
Kampala
Country
Uganda
Facility Name
Joint Clinical Research Centre
City
Kampala
Country
Uganda
Facility Name
MU-JHU Research Collaboration CRS
City
Kampala
Country
Uganda
Facility Name
Cfhrz Crs
City
Lusaka
Country
Zambia
Facility Name
Matero Reference Clinic CRS
City
Lusaka
Country
Zambia
Facility Name
UNC Global Projects / Kamwala District Health Centre
City
Lusaka
Country
Zambia
Facility Name
Zambia Emory HIV Research Project - Ndola CoVPN CRS
City
Ndola
Country
Zambia

12. IPD Sharing Statement

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

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