NCT04130594

Study of Safety and Immunogenicity of BVRS-GamVac

Status unknown Phase 1, PHASE2 Last updated 14 January 2021

What this trial tests

Phase 1, PHASE2 trial testing BVRS-GamVac in MERS (Middle East Respiratory Syndrome) in 162 participants. Status unknown.

Timeline

7 November 2019

Primary endpoint
1 July 2021

31 July 2021

Quick facts

Lead sponsor	Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	162
Start date	7 November 2019
Primary completion	1 July 2021
Estimated completion	31 July 2021
Sites	1 location across Russia

Drugs / interventions tested

• BVRS-GamVac — full drug profile →
• placebo

Conditions studied

• MERS (Middle East Respiratory Syndrome) — all drugs for MERS (Middle East Respiratory Syndrome) →
• MERS — all drugs for MERS →

Sponsor

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Who can join

Adults 18 to 55, any sex, with MERS (Middle East Respiratory Syndrome) or MERS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of \~34.5%.

The aim of the study is to assess the safety and immunogenicity of adenoviral-based vaccine against MERS - BVRS-GamVac.

Publications & conference data

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

1. Coronavirus vaccine development: from SARS and MERS to COVID-19.
   Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2
2. COVID-19 Coronavirus Vaccine Design Using Reverse Vaccinology and Machine Learning.
   Ong E, Wong MU, Huffman A, He Y. · · 2020 · cited 241× · PMID 32719684 · DOI 10.3389/fimmu.2020.01581
3. Viral vector-based gene therapies in the clinic.
   Zhao Z, Anselmo AC, Mitragotri S. · · 2022 · cited 171× · PMID 35079633 · DOI 10.1002/btm2.10258
4. Vaccine Candidates against Coronavirus Infections. Where Does COVID-19 Stand?
   Al-Kassmy J, Pedersen J, Kobinger G. · · 2020 · cited 37× · PMID 32784685 · DOI 10.3390/v12080861
5. Developmental Landscape of Potential Vaccine Candidates Based on Viral Vector for Prophylaxis of COVID-19.
   Bezbaruah R, Borah P, Kakoti BB, Al-Shar'I NA, et al · · 2021 · cited 21× · PMID 33937326 · DOI 10.3389/fmolb.2021.635337
6. Coronavirus in human diseases: Mechanisms and advances in clinical treatment.
   Lin P, Wang M, Wei Y, Kim T, et al · · 2020 · cited 21× · PMID 33173860 · DOI 10.1002/mco2.26
7. Middle East Respiratory Syndrome coronavirus vaccine development: updating clinical studies using platform technologies.
   Choi JA, Kim JO. · · 2022 · cited 9× · PMID 35089585 · DOI 10.1007/s12275-022-1547-8
8. Perspectives on development of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
   Zhang C, Zhou C, Shi L, Liu G. · · 2020 · cited 6× · PMID 32961082 · DOI 10.1080/21645515.2020.1787064