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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05168813
Other study ID # CoVPN 3008
Secondary ID UM1AI068614
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date December 1, 2021
Est. completion date April 19, 2024

Study information

Verified date May 2024
Source COVID-19 Prevention Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 14232
Est. completion date April 19, 2024
Est. primary completion date April 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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).
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.
Vaccine 2 Dose
COVID-19 mRNA vaccine is to be administered as IM injection into the deltoid muscle on Day 1 and Day 169.

Locations

Country Name City State
Botswana Gaborone CRS Gaborone
Kenya Moi University Clinical Research Centre Eldoret
Kenya Kisumu - Kombewa CRS Kisumu
Kenya Kisumu Crs Kisumu
Malawi Blantyre CRS Blantyre
Malawi Malawi CRS Lilongwe
South Africa Josha Resarch CRS Bloemfontein Free State
South Africa Emavundleni CRS Cape Town Western Cape
South Africa FAM-CRU (Family Clinical Research Unit) Cape Town Western Cape
South Africa Groote Schuur HIV CRS Cape Town Western Cape
South Africa Masiphumelele Clinical Research Site (MASI) CRS Cape Town Western Cape
South Africa TASK Central Cape Town Western Cape
South Africa Univeristy of Cape Town Lung CRS Institute Cape Town Western Cape
South Africa CAPRISA eThekwini CRS Durban KwaZulu-Natal
South Africa Tongaat CRS Durban KwaZulu-Natal
South Africa Vulindlela CRS Durban KwaZulu-Natal
South Africa Synergy Biomed Research Institute East London Eastern Cape
South Africa Ndlovu Research Centre CoVPN CRS Elandsdoorn
South Africa MeCRU CRS Ga-Rankuwa Gauteng
South Africa TASK Eden George Western Cape
South Africa Isipingo CRS Isipingo KwaZulu-Natal
South Africa Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS Johannesburg Gauteng
South Africa Kliptown Soweto CRS Johannesburg
South Africa Newtown Clinical Research Johannesburg Gauteng
South Africa Soweto - Bara CRS Johannesburg Gauteng
South Africa Wits RHI Ward 21 CRS Johannesburg Gauteng
South Africa Aurum Institute Klerksdorp CRS Klerksdorp North West
South Africa PHRU Matlosana CRS Klerksdorp
South Africa Qhakaza Mbokodo Research Clinic CRS Ladysmith KwaZulu-Natal
South Africa MERC Middelburg Middelburg Mpumalanga
South Africa Nelson Mandela Academic Research Unit CRS Mthatha Eastern Cape
South Africa PHOENIX Pharma (Pty) Ltd Port Elizabeth Eastern Cape
South Africa MERC Kempton Park Pretoria Gauteng
South Africa Synexus Stanza Clinical Research Centre (CRS) Pretoria Gauteng
South Africa Rustenburg CRS Rustenburg North West
South Africa Synexus Helderberg Stellenbosch Western Cape
South Africa Tembisa Clinic 4 CoVPN CRS Tembisa Gauteng
South Africa MERC Welkom Welkom
Swaziland Eswatini Prevention Center CRS Mbabane Hhohho
Uganda UVRI-IAVI HIV Vaccine Program LTD. CRS Entebbe
Uganda Baylor-Uganda CRS Kampala
Uganda Joint Clinical Research Centre Kampala
Uganda MU-JHU Research Collaboration CRS Kampala
Zambia Cfhrz Crs Lusaka
Zambia Matero Reference Clinic CRS Lusaka
Zambia UNC Global Projects / Kamwala District Health Centre Lusaka
Zambia Zambia Emory HIV Research Project - Ndola CoVPN CRS Ndola

Sponsors (3)

Lead Sponsor Collaborator
COVID-19 Prevention Network Medical Research Council, South Africa, National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Measured 1 day after Month 0 dose until Month 6 dose
Primary 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 Measured 1 day after Month 0 dose until Month 6 dose
Primary 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 Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year
Primary 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 Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year
Primary 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 Measured both pre-Month 6 and post-Month 6 stages
Secondary 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 Measured at least 14 days after the last pre-Month 6 dose until the Month 6 dose
Secondary 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 Measured starting 1 day after dose 1 through 14 days after the last pre-Month 6 dose until the Month 6 dose.
Secondary 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 Measured at least 14 days after Month 6 injection
Secondary 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 Measured at least 14 days after the Month 6 dose, through study completion, an average of 1 year
Secondary 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 Measured least 14 days after the Month 6 dose, through study completion, an average of 1 year
Secondary Number of SARS-CoV-2 infection Measured by neutralization phenotypes and viral genotypic characteristics of SARS-CoV-2 at diagnosis. 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
Secondary Number of SARS-CoV-2 infection SARS-CoV-2 infection diagnosed by seroconversion throughout the study 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
Secondary Positive result of acute and severe SARS-CoV-2 infection SARS-CoV-2 infection diagnosed by seroconversion in the absence of symptoms 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
Secondary 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. 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
Secondary Number of SARS-CoV-2 infection SARS-CoV-2 viral load (as inferred from RT-PCR cycle threshold values) Through study completion after Dose 1 vaccination, an average of 1 year
Secondary Number of SARS-CoV-2 infection Viral whole genome sequences Through study completion after Dose 1 vaccination, an average of 1 year
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