Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. (Currently on Ubuntu Version 8.0 Amendment 7.0)

Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202105817814362

Enrollment

15600

Registered

2021-05-24

Start date

2021-06-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19

Interventions

mRNA 1273

mRNA 1273 deferred vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 1. Prior receipt of a SARS-CoV-2 vaccine. 2. 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]), CoVPN 3008 (Ubuntu) Version 8.0 / June 28, 2023 CoVPN3008_v8.0_Final_28June23 / Page 61 of 169 tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose). 3. 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). 4. 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). 5. Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination.

Design outcomes

Primary

Measure	Time frame
PRE-MONTH 6 STAGE: to assess the relative risk of symptomatic COVID-19 in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) who receive a 2-dose mRNA-1273 vaccine regimen in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose mRNA-1273 regimen, counting endpoints starting 1 day after Month 0 dose until Month 6 dose PRE-MONTH 6 STAGE: to assess the relative risk of severe COVID-19 in Group 1 (PLWH who are SARSCoV-2 negative at baseline) who receive a 2-dose mRNA1273 vaccine regimen in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose mRNA-1273 regimen, counting endpoints starting 1 day after Month 0 dose until Month 6 dose. POST-MONTH 6 STAGE: to assess the relative risk of symptomatic COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up. POST-MONTH 6 STAGE: to assess the relative risk of severe COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up. To assess the safety and tolerability of mRNA-1273 and mRNA-1273.222 in adults who are at risk of severe COVID-19 in both the pre-Month 6 and post-Month 6 stages.	—

Measure

Time frame

PRE-MONTH 6 STAGE: to assess the relative risk of symptomatic COVID-19 in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) who receive a 2-dose mRNA-1273 vaccine regimen in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose mRNA-1273 regimen, counting endpoints starting 1 day after Month 0 dose until Month 6 dose PRE-MONTH 6 STAGE: to assess the relative risk of severe COVID-19 in Group 1 (PLWH who are SARSCoV-2 negative at baseline) who receive a 2-dose mRNA1273 vaccine regimen in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose mRNA-1273 regimen, counting endpoints starting 1 day after Month 0 dose until Month 6 dose. POST-MONTH 6 STAGE: to assess the relative risk of symptomatic COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up. POST-MONTH 6 STAGE: to assess the relative risk of severe COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up. To assess the safety and tolerability of mRNA-1273 and mRNA-1273.222 in adults who are at risk of severe COVID-19 in both the pre-Month 6 and post-Month 6 stages.

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Secondary

Measure	Time frame
PRE-MONTH 6 & POST-MONTH 6 STAGES: to assess the relative risk of asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion after the Month 6 dose in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) and in Group 3 (people HIV-negative who are SARS-CoV-2 negative at baseline) combined, among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints starting 1 day after dose 1, 14 days after the last dose before Month 6 dose, or 14 days after Month 6 dose until the end of follow up PRE-MONTH 6 & POST-MONTH 6 STAGES: to assess the relative risk of symptomatic COVID-19, and severe COVID-19 after the Month 6 dose in Groups 1 and 3 together (participants who are SARS-CoV-2 negative at baseline regardless of HIV status) and in Groups 2 and 4 together (participants who are SARS-CoV-2 positive at baseline regardless of HIV status), respectively, among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints starting 1 day after dose 1 or 14 days after the last dose before Month 6 dose until the end of follow up. SARS-CoV-2 viral load (as inferred from RT-PCR cycle threshold values) and viral whole genome sequences . To assess post-vaccination immune response markers and immune markers as correlates of risk of COVID-19 and as correlates of protection against COVID-19 in all study groups together.	—

Measure

Time frame

PRE-MONTH 6 & POST-MONTH 6 STAGES: to assess the relative risk of asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion after the Month 6 dose in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) and in Group 3 (people HIV-negative who are SARS-CoV-2 negative at baseline) combined, among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints starting 1 day after dose 1, 14 days after the last dose before Month 6 dose, or 14 days after Month 6 dose until the end of follow up PRE-MONTH 6 & POST-MONTH 6 STAGES: to assess the relative risk of symptomatic COVID-19, and severe COVID-19 after the Month 6 dose in Groups 1 and 3 together (participants who are SARS-CoV-2 negative at baseline regardless of HIV status) and in Groups 2 and 4 together (participants who are SARS-CoV-2 positive at baseline regardless of HIV status), respectively, among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints starting 1 day after dose 1 or 14 days after the last dose before Month 6 dose until the end of follow up. SARS-CoV-2 viral load (as inferred from RT-PCR cycle threshold values) and viral whole genome sequences . To assess post-vaccination immune response markers and immune markers as correlates of risk of COVID-19 and as correlates of protection against COVID-19 in all study groups together.

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Countries

Botswana, Kenya, Malawi, South Africa, Swaziland, Uganda, Zambia

Contacts

Public ContactGlenda Gray

Sponsor representative

glenda.gray@mrc.ac.za+27123398524

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026