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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)

NCT05037188 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-01-30

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2022-04-18
Completion
2022-04-18

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037188 on ClinicalTrials.gov