NCT05046548

This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19

Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", on adult volunteers aged 18-60" (Clinical trials, phase I/II). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine sorbed on adult volunteers aged 18-60.

Detailed description

The study is divided into 3 stages. At Stages I and II of the study, a maximum of 300 healthy volunteers aged 18 to 60 years should be screened, of which 200 volunteers meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the tolerability and safety of the vaccine. Stage I includes 15 men and women: Group 1 - 10 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Group 2 - 5 volunteers who will receive placebo twice with an interval of 14 days intramuscularly at a dose of 0.5 ml with a post-vaccination observation period of 28 days. Stage II includes 185 volunteers: Group 1 - 140 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Group 2 - 45 volunteers who received placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Stage III of the study, a maximum of 300 volunteers should be screened, of which 200 volunteers, meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the safety and immunogenicity of the vaccine. Group 3 - 150 volunteers who will receive the vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a period of post-vaccination observation for 6 months. Group 4 - 50 volunteers who will receive placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 6 months.

Conditions

• Coronavirus Infections
• Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine for intramuscular injection	Volunteers (10 at the Stage 1; 140 at the Stage 2; 150 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml
OTHER	Placebo comparator (without active ingredient) for intramuscular injection	Volunteers (5 at the Stage 1; 45 at the Stage 2; 50 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml

Timeline

• Start date: 2020-10-03
• Primary completion: 2020-10-15
• Completion: 2021-10-01
• First posted: 2021-09-16
• Last updated: 2021-11-12

Locations

5 sites across 1 country: Russia