Study of Safety and Immunogenicity of BVRS-GamVac

2019-10-23 13:11:48 | BioPortfolio


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.


Two-stage, open-dose, prospective, double-blind, randomized, placebo-controlled study in parallel groups The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 162 (will receive the study drug or placebo) healthy volunteers, of which the first stage, it is planned to vaccinate 40 person with the studied drug (at the same time, the participation of 8 spares *), at the second phase - 122 people, of whom 88 will receive the study drug, and 34 will make up the control group of observation - they will be given a placebo drug.

* Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then its replacement is not performed.

Any volunteer who received a dose of the test drug will be considered as included in the study, the data available on it will be used in assessing the safety and tolerability of the drug.

Study Design


MERS (Middle East Respiratory Syndrome)


BVRS-GamVac, placebo


Research Institute of Influenza
Russian Federation


Not yet recruiting


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

Results (where available)

View Results


Published on BioPortfolio: 2019-10-23T13:11:48-0400

Clinical Trials [2969 Associated Clinical Trials listed on BioPortfolio]

Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S

The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Hea...

A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate (MERS-CoV) Vaccine ChAdOx1 MERS

A phase Ib study to determine the safety and immunogenicity of the candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle Eastern vo...

Safety and Immunogenicity of a Candidate MERS-CoV Vaccine (MERS001)

This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone as a single administration.

Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety and Immunogenicity of MVA-MERS-S_DF-1

The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody re...

A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of BVRS-GamVac-Combi

Two-stage, open-dose, prospective, double-blind, randomized, placebo-controlled study in parallel groups

PubMed Articles [10605 Associated PubMed Articles listed on BioPortfolio]

Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial.

Middle East respiratory syndrome (MERS) coronavirus causes a highly fatal lower-respiratory tract infection. There are as yet no licensed MERS vaccines or therapeutics. This study (WRAIR-2274) assesse...

MERS-CoV as an emerging respiratory illness: A review of prevention methods.

Middle East Respiratory Coronavirus Virus (MERS-CoV) first emerged from Saudi Arabia in 2012 and has since been recognized as a significant human respiratory pathogen on a global level.

Activation of C-type lectin receptor and (RIG)-I-like receptors contributes to proinflammatory response in MERS coronavirus infected macrophages.

Human infection with Middle East respiratory syndrome coronavirus (MERS-CoV) poses an ongoing threat to public health worldwide. The studies of MERS patients with severe disease and experimentally-inf...

Preparation of virus-like particle mimetic nanovesicles displaying the S protein of Middle East respiratory syndrome coronavirus using insect cells.

Middle East respiratory syndrome coronavirus (MERS-CoV) first emerged in 2012, and over 2000 infections and 800 deaths have been confirmed in 27 countries. However, to date, no commercial vaccine is a...

Risk Factors for Fatal Middle East Respiratory Syndrome Coronavirus Infections in Saudi Arabia: Analysis of the WHO Line List, 2013-2018.

To explore complex associations among demographic factors, risk factors, health care, and fatality rates of Middle East respiratory syndrome coronavirus (MERS-CoV) in the Kingdom of Saudi Arabia. We ...

Medical and Biotech [MESH] Definitions

A coronavirus first reported in the summer of 2012 in a pneumonia patient in SAUDI ARABIA. It is related to SARS VIRUS. MERS-CoV has an estimated incubation period of 12 days and symptoms include renal failure and severe acute pneumonia with often fatal outcome.

A syndrome characterized by outbreaks of late term abortions, high numbers of stillbirths and mummified or weak newborn piglets, and respiratory disease in young unweaned and weaned pigs. It is caused by PORCINE RESPIRATORY AND REPRODUCTIVE SYNDROME VIRUS. (Radostits et al., Veterinary Medicine, 8th ed, p1048)

The countries of southwest Asia and northeastern Africa usually considered as extending from Libya on the west to Afghanistan on the east. (From Webster's New Geographical Dictionary, 1988)

Condition characterized by large, rapidly extending, erythematous, tender plaques on the upper body usually accompanied by fever and dermal infiltration of neutrophilic leukocytes. It occurs mostly in middle-aged women, is often preceded by an upper respiratory infection, and clinically resembles ERYTHEMA MULTIFORME. Sweet syndrome is associated with LEUKEMIA.

A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA.

More From BioPortfolio on "Study of Safety and Immunogenicity of BVRS-GamVac"

Quick Search

Relevant Topics

Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...

Searches Linking to this Trial