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Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults

NCT05228314 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2023-07-03

No results posted yet for this study

Summary

This is a phase 1 study to assess the safety and immunogenicity of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine (SCB-2020S vaccine), when administered as 2 dose vaccination series 21 days apart to adults ≥18 to ≤75 years of age.

Conditions

Interventions

BIOLOGICAL

Candidate vaccine, SCB-2020S

a recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19

BIOLOGICAL

Candidate vaccine, SCB-2019

a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19

OTHER

Squalene based adjuvant

Squalene based adjuvant

OTHER

CpG/alum adjuvant

CpG/alum adjuvant

Sponsors & Collaborators

  • Clover Biopharmaceuticals AUS Pty

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2022-09-23
Completion
2023-04-23

Countries

  • 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 NCT05228314 on ClinicalTrials.gov