Study of Safety and Immunogenicity of BVRS-GamVac-Combi (NCT04128059) | Clinical Trial Compass
UnknownPhase 1/2
Study of Safety and Immunogenicity of BVRS-GamVac-Combi
Russia268 participantsStarted 2019-11-06
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. written informed consent;
✓. absence of a history, as well as according to a screening examination of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, urogenital, immune and endocrine systems, blood, which may affect volunteer safety and evaluation of the results of the study (clinical, instrumental and laboratory studies did not reveal diseases or clinically significant deviations);
✓. males and females within the age range from 18 to 55 years;
✓. Consent to the use of effective methods of contraception during the entire period of participation in the study;
✓. subject body mass index (BMI): 18.5 ≤ BMI ≤ 30;
✓. absence of acute infectious diseases at the time of vaccination and 7 days before vaccination;
✓. absence of severe allergic diseases in the medical history
✓. no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products;
Exclusion criteria
✕. Volunteer participation in any other study over the past 90 days;
✕. Any vaccination in the last 30 days;
✕. Acute infectious and non-infectious diseases, exacerbations of chronic diseases within 4 weeks prior to screening;
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: through the whole study, an average of 180 days
2
Number of Participants With Serious Adverse Events
Timeframe: through the whole study, an average of 180 days
3
Number of Participants with Solicited Local and Systemic Adverse Events
Timeframe: through the whole study, an average of 180 days
4
Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)
Timeframe: 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
Trial details
NCT IDNCT04128059
SponsorGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
. subject has received treatment with steroids for the last 10 days;
✕. subject has received immunoglobulins or other blood products over the last 3 months;
✕. subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study;
✕. Pregnancy or lactation;
✕. subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 100 beats per minute;