NCT05148091

The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults

A Randomized, Double-blind, Placebo-controlled Phase Ⅰ/Ⅱ Clinical Study to Evaluate the Safety, Tolerability and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Unvaccinated Against COVID-19

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

SCTV01C-02-1 is a randomized, double-blind, placebo controlled Phase Ⅰ/Ⅱ clinical trial of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant bivalent trimeric S protein vaccine manufactured by Sinocelltech, Ltd. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental vaccine in healthy adults aged ≥ 18 Years previously unvaccinated.

Detailed description

This study is a randomized, double-blind, multi-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged ≥ 18 years previously unvaccinated. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental SARS-CoV-2 protein vaccine (SCTV01C). The experimental vaccine and adjuvant (one placebo) were both manufactured by Sinocelltech, Ltd., while the saline (the other placebo) was commercially purchased. A total of 752 participants will be enrolled, with 112 at phase Ⅰ, and 640 at phase Ⅱ. There will be two dosage levels (20μg and 40μg), and two age groups (18\~59 years old and ≥ 60 years old ) at both Phase Ⅰ and Phase Ⅱ. All of participants will be assigned to receive two doses of experimental vaccine(20μg or 40μg) or placebo (Adjuvant or Saline) on the schedule of Day 0 and Day 28.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SCTV01C	A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
OTHER	Adjuvant	SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
OTHER	Saline	Saline is used as the other control in the trial

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-08-04
• Completion: 2023-08-04
• First posted: 2021-12-08
• Last updated: 2024-02-08

Locations

5 sites across 1 country: China