MedTrace Logo

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

NCT04672395 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 31454

Last updated 2023-06-29

No results posted yet for this study

Summary

The purpose of this double-blind, randomized, controlled study is to evaluate the efficacy, immunogenicity, reactogenicity and safety of an adjuvanted recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) trimeric spike (S)-protein subunit vaccine (SCB-2019) for the prevention of SARS-CoV-2-mediated COVID-19 in Participants Aged 12 Years and Older.

Conditions

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

Sponsors & Collaborators

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • International Vaccine Institute

    collaborator OTHER

  • Clover Biopharmaceuticals AUS Pty

    lead INDUSTRY

Principal Investigators

  • Igor Smolenov, MD, PhD · Clover Biopharmaceuticals AUS Pty

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2022-09-15
Completion
2023-04-23

Countries

  • Belgium
  • Brazil
  • Colombia
  • Philippines
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672395 on ClinicalTrials.gov