An Open Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac Vector Vaccine Against Influenza A in Healthy Volunteers in 3 Groups With a Dose Escalation
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza A Virus Infection
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The present clinical phase I study designed to examine the safety, reactogenicity and immunogenicity of the medicinal product - Vaccine vector against influenza A - in healthy volunteers after a single dose in the three groups with dose escalation.
Detailed Description
According to the results of the screening of volunteers who signed the informed consent Form, a sequential set of three groups of volunteers with different doses of the drug, the total number of volunteers who received the drug will be at least 36 people. Given the fact that the drug is investigated for the first time with the participation of the people, will initially be admitted to hospital on 5 volunteers who will receive the investigational drug in the 1 dose The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) x 10\*10 VP/dose). If the safety of the drug is confirmed by the results of observation on the 7th day of the study, the study will continue with the participation of 7 more volunteers in this dosing group. Further, according to a similar scheme (each time after an interim safety assessment on day 7), the study will include volunteers receiving the drug at a dose of 0.5 ml (Total amount of recombinant pseudo-adenoviral particles (1.0 ± 0.5) x 1011 VP/dose), particles/dose and 0.5 ml, -The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women aged 18 to 55 years old.
- •Written informed consent.
- •consent to the use of effective contraceptive methods throughout the study period \*
- •\* using one of the following methods: abstinence, condoms (male or female with or without spermicide), diaphragm or cervical cap with spermicide, intrauterine device
- •body mass index (BMI) from 18.5 to
- •absence of acute infectious diseases or exacerbation of chronic infections at the time of vaccination and 7 days before vaccination;
- •absence of allergic diseases of a serious degree (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness)
- •absence of strong post-vaccination reactions or post-vaccination complications for previous use of immunobiological drugs;
- •absence of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary and endocrine systems, which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data;
- •negative pregnancy test (for fertile women);
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: Through the whole study, an average of 28 days
Determination of Number of Participants With Adverse Events
Secondary Outcomes
- Assessment of antigen-specific cell-mediated immune response(at days 0 and 7)
- Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)(at days 0 and 28)