NCT04950751

Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults

An Observer-blind, Randomized, Controlled, Phase 2 Study to Evaluate the Immunogenicity and Safety of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Clover Biopharmaceuticals AUS Pty · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a phase 2, randomized, controlled, observer-blind study to evaluate the immunogenicity and safety of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from B.1.351 variant) subunit vaccine (SCB-2020S), when administered as 2-dose vaccination series 21 days apart to adults ≥ 18 years of age.

Detailed description

Clover has developed a second candidate vaccine, SCB-2020S, that contains S protein from the dominant B.1.351 variant. The purpose of clinical study CLO-SCB-2020-001 is to assess the immunogenicity and safety of different formulations of the SCB-2020S compared to the prototype SCB-2019 vaccine, and to select a formulation of SCB-2020S for further clinical development. The protocol plans to enroll 150 participants. There will be 5 study arms and participants will receive two intramuscular (i.m.) injections, one at Day 1 and one at Day 22.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	candidate vaccine, SCB-2020S	a recombinant SARS-Co-2 trimeric S-protein (from B.1.351 variant) subunit vaccine for COVID-19

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-07-06
• Last updated: 2021-09-10