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BVRS-GamVac-CombiWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug528 NA (no intervention) Wiki 1.00
drug1003 placebo Wiki 0.38

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D013577 Syndrome NIH 0.15
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers

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 heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.

NCT04128059 MERS (Middle East Respiratory Syndrome) MERS Drug: BVRS-GamVac-Combi Other: placebo
MeSH:Coronavirus Infections Syndrome

Primary Outcomes

Description: Determination of Number of Participants With Adverse Events

Measure: Number of Participants With Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of Number of Participants With Serious Adverse Events

Measure: Number of Participants With Serious Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of Number of Participants with Solicited Local and Systemic Adverse Events

Measure: Number of Participants with Solicited Local and Systemic Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)

Measure: Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)

Time: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90

Secondary Outcomes

Description: determination of specific T-cell- mediated response vs. baseline values and placebo

Measure: Assessment of antigen-specific cell-mediated immune response

Time: at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2)

Description: Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo

Measure: Neutralizing antibody levels

Time: at days 0, 14 and 28 from the start of vaccination compared to baseline values


No related HPO nodes (Using clinical trials)