NCT04672395 - A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 | Biotech Hunter

Enrollment

31,454

Participants

Timeline

Start Date

March 24, 2021

Primary Completion Date

September 15, 2022

Study Completion Date

April 23, 2023

Conditions

COVID-19

Interventions

BIOLOGICAL

CpG 1018/Alum-adjuvanted SCB-2019 vaccine

Group 1: Participants will receive 1 intramuscular (IM) injection of 30 microgram (ug) SCB-2019 with CpG1018/Alum adjuvant on Day 1 and on Day 22

BIOLOGICAL

Placebo; 0.9% saline

Group 2: Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 1 and on Day 22

BIOLOGICAL

SCB-2019 vaccine

Participants will receive 1 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant

BIOLOGICAL

SCB-2019 vaccine for Placebo

Participants will receive 2 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant, 21 days apart

Trial Locations (31)

1000

Manila Doctors Hospital, Manila

1070

Hôspital Erasme, Brussels

1100

UERM Memorial Medical Center, Quezon City

University of the East Ramon Magsaysay Memorial Medical Center, Quezon City

1118

FEU-NRMF Medical Center, Quezon City

1230

Tropical Disease Foundation, Makati

1301

University of the Philippines Manila - Philippine General Hospital, Pasay

1634

St. Luke's Medical Center, City of Taguig

1739

DJW Research, Krugersdorp

1742

Las Pinas Doctors Hospital, Las Piñas

1781

Asian Hospital and Medical Center, City of Muntinlupa

1818

Soweto Clinical Trials Centre, Soweto

2013

Wits Clinical Research, Johannesburg

3570

Anima, Alken

4114

De La Salle Medical and Health Sciences Institute, Dasmariñas

5101

Private Practice RESPISOM Namur, Namur

7130

Dr JM Engelbrecht Trial Site, Somerset West

850001

Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Yopal, Yopal

22281-100

Instituto D'OR de Pesquisa e Ensino, Rio de Janeiro

59020-500

Instituto Atena de Pesquisa Clinica, Natal

59025-050

CPCLIN - Centro de Pesquisas Clínicas de Natal, Natal

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

97105-900

Hospital da Universidade Federal de Santa Maria CEP/UFSM, Santa Maria

Unknown

Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Acacias, Acacías

Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede Aguazul, Aguazul

Fundación Hospital Universitario del Norte, Barranquilla

Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Bogotá D.C., Bogotá

Policlinico Social del Norte, Bogotá

IPS Médicos Internistas de Caldas SAS, Manizales

Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S., Santiago de Cali

080020

Clínica de la Costa Ltda, Barranquilla