NCT05270954: Betuvax-CoV2

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

Status unknown Phase 1, PHASE2 Last updated 8 March 2022

What this trial tests

Phase 1, PHASE2 trial testing Betuvax-CoV-2 in COVID-19 in 116 participants. Status unknown.

Timeline

14 October 2021

Primary endpoint
25 April 2022

24 July 2022

Quick facts

Lead sponsor	Artgen Biotech
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	116
Start date	14 October 2021
Primary completion	25 April 2022
Estimated completion	24 July 2022
Sites	3 locations across Russia

Drugs / interventions tested

• Betuvax-CoV-2 — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Artgen Biotech — full company profile →

Who can join

Adults 18 to 60, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vaccine adjuvants for infectious disease in the clinic.
   Goetz M, Thotathil N, Zhao Z, Mitragotri S. · · 2024 · cited 29× · PMID 39036089 · DOI 10.1002/btm2.10663
2. Recombinant Protein Vaccines against Human Betacoronaviruses: Strategies, Approaches and Progress.
   Kovalenko A, Ryabchevskaya E, Evtushenko E, Nikitin N, et al · · 2023 · cited 15× · PMID 36675218 · DOI 10.3390/ijms24021701
3. Safety and Immunogenicity of Betuvax-CoV-2, an RBD-Fc-Based SARS-CoV-2 Recombinant Vaccine: Preliminary Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Trial.
   Kudriavtsev AV, Vakhrusheva AV, Kryuchkov NA, Frolova ME, et al · · 2023 · cited 12× · PMID 36851204 · DOI 10.3390/vaccines11020326
4. SARS-CoV-2 Subunit Virus-like Vaccine Demonstrates High Safety Profile and Protective Efficacy: Preclinical Study.
   Vakhrusheva AV, Kudriavtsev AV, Kryuchkov NA, Deev RV, et al · · 2022 · cited 5× · PMID 36016181 · DOI 10.3390/vaccines10081290
5. Comparative Analysis of the Neutralizing Capacity of Monovalent and Bivalent Formulations of Betuvax-CoV-2, a Subunit Recombinant COVID-19 Vaccine, Against Various Strains of SARS-CoV-2.
   Vakhrusheva AV, Romanovskaya-Romanko EA, Stukova MA, Sukhova MM, et al · · 2024 · cited 1× · PMID 39460365 · DOI 10.3390/vaccines12101200
6. SARS-CoV-2 Subunit Virus-Like Vaccine Demonstrates High Safety Profile and Protective Efficacy: Preclinical Study
   Vakhrusheva A, Kudriavtsev A, Kryuchkov N, Deev R, et al · · 2022 · DOI 10.1101/2022.05.18.492452