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Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine Betuvax-CoV-2

NCT05270954 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-03-08

No results posted yet for this study

Summary

Randomized, double-blind, multicenter parallel-group clinical study of safety, tolerability and immunogenicity of the Betuvax-CoV-2 vaccine. The aim of this study is to investigate the safety, tolerability and immunogenicity of the Betuvax-CoV-2 Recombinant vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus, suspension for intramuscular administration, 10 μg/ml and 40 μg/ml (Ltd. Institute of New Medical Technologies, Russia) in healthy adult volunteers, aged 18 to 60 (inclusive).

Conditions

Interventions

BIOLOGICAL

Betuvax-CoV-2

Vaccine: Betuvax-CoV-2 intramuscular injection solution (0.5 ml)

DRUG

Placebo

Placebo: a 0.9% NaCl intramuscular injection solution (0.5 ml)

Sponsors & Collaborators

  • Betuvax LLC

    collaborator UNKNOWN

  • CEG BIO LLC

    collaborator UNKNOWN

  • Artgen Biotech

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2022-04-25
Completion
2022-07-24

Countries

  • Russia

Study Locations

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Entities

Drugs
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 NCT05270954 on ClinicalTrials.gov