Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern (CoVPN3008)
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| ClinicalTrials.gov Identifier: NCT05168813 |
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Recruitment Status :
Active, not recruiting
First Posted : December 23, 2021
Last Update Posted : June 7, 2023
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Sponsor:
COVID-19 Prevention Network
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Medical Research Council, South Africa
Information provided by (Responsible Party):
COVID-19 Prevention Network
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| SARS-CoV-2 Infection HIV Infections COVID-19 | Biological: Moderna mRNA-1273 Biological: Vaccine 3 Dose Biological: Vaccine 2 Dose | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14232 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern |
| Actual Study Start Date : | December 1, 2021 |
| Estimated Primary Completion Date : | October 15, 2023 |
| Estimated Study Completion Date : | April 24, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1
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.
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Biological: Moderna mRNA-1273
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). Biological: Vaccine 3 Dose COVID-19 mRNA vaccine in 100 mcg dose given as IM injection into the deltoid muscle on Day 1, Day 29, and Day 169. |
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Experimental: Group 2
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.
|
Biological: Moderna mRNA-1273
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). Biological: Vaccine 2 Dose COVID-19 mRNA vaccine is to be administered as IM injection into the deltoid muscle on Day 1 and Day 169. |
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Experimental: Group 3
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.
|
Biological: Moderna mRNA-1273
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). Biological: Vaccine 3 Dose COVID-19 mRNA vaccine in 100 mcg dose given as IM injection into the deltoid muscle on Day 1, Day 29, and Day 169. |
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Experimental: Group 4
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.
|
Biological: Moderna mRNA-1273
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). Biological: Vaccine 2 Dose COVID-19 mRNA vaccine is to be administered as IM injection into the deltoid muscle on Day 1 and Day 169. |
Primary Outcome Measures :
- 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 vs. in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose regimen [ Time Frame: Measured 1 day after Month 0 dose until Month 6 dose ]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
- to assess the relative risk of severe COVID-19 in Group 1 (PLWH who are SARS- CoV-2 negative at baseline) who receive a 2-dose mRNA- 1273 vaccine regimen vs. in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose [ Time Frame: Measured 1 day after Month 0 dose until Month 6 dose ]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
- To assess the relative risk of symptomatic COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints least 14 days after the Month 6 dose until end of follow up. [ Time Frame: Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year ]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
- To assess the relative risk of severe COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints least 14 days after the Month 6 dose until end of follow up. [ Time Frame: Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year ]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
- To assess the safety and tolerability of mRNA-1273 and mRNA-1273.222 in adults who are at risk of severe COVID 6 and post-Month 6 stages. [ Time Frame: Measured 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
Secondary Outcome Measures :
- To assess the relative risk of symptomatic COVID-19 and of severe COVID-19 in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) vs. in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) [ Time Frame: Measured at least 14 days after the last pre-Month 6 dose until the Month 6 dose ]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
- To assess the relative risk of symptomatic COVID-19 and of severe COVID-19 in Groups 1 and 3 together vs. in Groups 2 and 4 together [ Time Frame: Measured at least 14 days after the last pre-Month 6 dose until the Month 6 dose. ]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
- To assess the relative risk of symptomatic COVID-19 and of severe COVID-19 in Group 1 and Group 2 separately and combined [ Time Frame: Measured at least 14 days after Month 6 injection ]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
- To assess the relative risk of symptomatic COVID-19 and of severe COVID-19 after the Month 6 dose in Group 1 and Group 2, separately and combined [ Time Frame: Measured at least 14 days after the Month 6 dose, through study completion, an average of 1 year ]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
- To assess the relative risk of virologically confirmed symptomatic COVID-19 and of severe COVID-19 after the Month 6 dose in Groups 1 and 3 together and in Groups 2 and 4 together [ Time Frame: Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year ]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
- To assess the relative risk of symptomatic COVID-19 and of severe COVID-19 after the Month 6 dose by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses in Groups 1 and 3 together and in Groups 2 and 4 together [ 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 ]Measured by neutralization phenotypes and viral genotypic characteristics of SARS-CoV-2 at diagnosis.
- To assess the relative risk of SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology after the Month 6 dose in Group 1 and in Group 3 [ 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 ]SARS-CoV-2 infection diagnosed by seroconversion throughout the study
- To assess the relative risk of asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion after the Month 6 dose in Group 1 and in Group 3 combined [ 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 ]SARS-CoV-2 infection diagnosed by seroconversion in the absence of symptoms
- To assess the relative risk of symptomatic COVID-19, and severe COVID-19 after the Month 6 dose in Groups 1 and 3 together and in Groups 2 and 4 together [ 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 ]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.
- To assess SARS-CoV-2 viral persistence among participants virologically diagnosed of SARS-CoV-2 infection in all study groups together. [ Time Frame: Through study completion after Dose 1 vaccination, an average of 1 year ]SARS-CoV-2 viral load (as inferred from RT-PCR cycle threshold values)
- To assess SARS-CoV-2 viral evolution among participants virologically [ Time Frame: Through study completion after Dose 1 vaccination, an average of 1 year ]Viral whole genome sequences
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
General and Demographic Criteria
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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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05168813
Locations
Show 47 study locations
Sponsors and Collaborators
COVID-19 Prevention Network
National Institute of Allergy and Infectious Diseases (NIAID)
Medical Research Council, South Africa
Investigators
| Study Chair: | Nigel Garrett | Centre for the AIDS Programme of Research in South Africa (CAPRISA) | |
| Study Chair: | Philip Kotze | Qhakaza Mbokodo Research Clinic | |
| Study Chair: | Sufia Dadabhai | Blantyre CRS / Johns Hopkins Research Project | |
| Study Chair: | Nyaradzo Mgodi | University of Zimbabwe Clinical Trials Research Centre |
| Responsible Party: | COVID-19 Prevention Network |
| ClinicalTrials.gov Identifier: | NCT05168813 |
| Other Study ID Numbers: |
CoVPN 3008 UM1AI068614 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 23, 2021 Key Record Dates |
| Last Update Posted: | June 7, 2023 |
| Last Verified: | June 2023 |
| 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 |
Keywords provided by COVID-19 Prevention Network:
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SARS-CoV-2 HIV COVID-19 |
Additional relevant MeSH terms:
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Infections Communicable Diseases COVID-19 Disease Attributes Pathologic Processes Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |