NCT05228314

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

A Phase 1, Observer-blind, Randomized, Controlled, Dose-finding Study to Evaluate the Safety and Immunogenicity of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults 18 to 75 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Clover Biopharmaceuticals AUS Pty · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-09-23
• Completion: 2023-04-23
• First posted: 2022-02-08
• Last updated: 2023-07-03

Locations

3 sites across 1 country: South Africa