Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-30 @ 11:11 AM
Study NCT ID:
NCT04130594
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2019-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Safety and Immunogenicity of BVRS-GamVac
Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Organization:
Study Overview
Official Title:
Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac", a 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
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 adenoviral-based vaccine against MERS - BVRS-GamVac.
The aim of the study is to assess the safety and immunogenicity of adenoviral-based vaccine against MERS - BVRS-GamVac.
Detailed Description:
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.
\* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: