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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

14,232

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

April 19, 2024

Study Completion Date

April 19, 2024

Conditions
SARS-CoV-2 InfectionHIV InfectionsCOVID-19
Interventions
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.

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.

Trial Locations (47)

40100

Kisumu - Kombewa CRS, Kisumu

Unknown

Gaborone CRS, Gaborone

Eswatini Prevention Center CRS, Mbabane

Moi University Clinical Research Centre, Eldoret

Kisumu Crs, Kisumu

Blantyre CRS, Blantyre

Malawi CRS, Lilongwe

Synergy Biomed Research Institute, East London

Nelson Mandela Academic Research Unit CRS, Mthatha

PHOENIX Pharma (Pty) Ltd, Port Elizabeth

Josha Resarch CRS, Bloemfontein

MeCRU CRS, Ga-Rankuwa

Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS, Johannesburg

Newtown Clinical Research, Johannesburg

Soweto - Bara CRS, Johannesburg

Wits RHI Ward 21 CRS, Johannesburg

MERC Kempton Park, Pretoria

Synexus Stanza Clinical Research Centre (CRS), Pretoria

Tembisa Clinic 4 CoVPN CRS, Tembisa

CAPRISA eThekwini CRS, Durban

Tongaat CRS, Durban

Vulindlela CRS, Durban

Isipingo CRS, Isipingo

Qhakaza Mbokodo Research Clinic CRS, Ladysmith

MERC Middelburg, Middelburg

Aurum Institute Klerksdorp CRS, Klerksdorp

Rustenburg CRS, Rustenburg

Emavundleni CRS, Cape Town

FAM-CRU (Family Clinical Research Unit), Cape Town

Groote Schuur HIV CRS, Cape Town

Masiphumelele Clinical Research Site (MASI) CRS, Cape Town

TASK Central, Cape Town

Univeristy of Cape Town Lung CRS Institute, Cape Town

TASK Eden, George

Synexus Helderberg, Stellenbosch

Ndlovu Research Centre CoVPN CRS, Elandsdoorn

Kliptown Soweto CRS, Johannesburg

PHRU Matlosana CRS, Klerksdorp

MERC Welkom, Welkom

UVRI-IAVI HIV Vaccine Program LTD. CRS, Entebbe

Baylor-Uganda CRS, Kampala

Joint Clinical Research Centre, Kampala

MU-JHU Research Collaboration CRS, Kampala

Cfhrz Crs, Lusaka

Matero Reference Clinic CRS, Lusaka

UNC Global Projects / Kamwala District Health Centre, Lusaka

Zambia Emory HIV Research Project - Ndola CoVPN CRS, Ndola

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Medical Research Council, South Africa

OTHER

lead

COVID-19 Prevention Network

NETWORK

NCT05168813 - Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern | Biotech Hunter | Biotech Hunter