NCT05037188

Clinical Study of the Safety and Immunogenicity of a Recombinant Viral Vector AAV5 (Adeno-Associated Virus Type 5 )-RBD (Receptor Binding Domain)-S Vaccine for the Prevention of Coronavirus Infection (COVID-19)

A Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless Phase I / II Clinical Study of the Safety and Immunogenicity of a Recombinant Viral Vector AAV5-RBD-S Vaccine for the Prevention of Coronavirus Infection (COVID-19)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled, adaptive, seamless phase I / II clinical study of the safety and immunogenicity of a recombinant viral vector AAV5-RBD-S vaccine for the prevention of coronavirus infection (COVID-19)

Detailed description

The study will be carried out in 2 stages. Stage 1 aims to assess the safety and immunogenicity of different doses of BCD-250 in subjects without a history of COVID-19 infection to choose the optimal dose for further investigation. Stage 2 aims to assess the immunogenicity and safety of the chosen on stage 1 optimal BCD-250 dose compared to placebo in subjects with and without the history of COVID-19 infection.

Conditions

• Coronavirus Infection
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Low dose BCD-250 injection	A recombinant viral vector AAV5-RBD-S vaccine
BIOLOGICAL	High dose BCD-250 injection	A recombinant viral vector AAV5-RBD-S vaccine
BIOLOGICAL	Low dose or high dose BCD-250 injection	A recombinant viral vector AAV5-RBD-S vaccine
OTHER	Placebo injection	Placebo injection

Timeline

• Start date: 2021-08-10
• Primary completion: 2022-04-18
• Completion: 2022-04-18
• First posted: 2021-09-08
• Last updated: 2023-01-30

Locations

2 sites across 1 country: Russia