The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac

NCT03651544 | Completed Phase 1

• 1 other identifier: 03-GamFluVac-2018
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza A Virus Infection; Influenza A; Influenza Epidemic; Influenza H5N1

Keywords

influenza; vaccine; vector vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Determination of Number of Participants With Adverse Events

  Through the whole study, an average of 28 days

Secondary Outcomes (2)

• 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

Study Arms (3)

Group 1 (GamFluVac dose1)

EXPERIMENTAL

The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) x 1010 VP/dose.

Biological: GamFluVac

Group 2 (GamFluVac dose2)

EXPERIMENTAL

Total amount of recombinant pseudo-adenoviral particles (1.0 ± 0.5) x 1011 VP/dose

Biological: GamFluVac

Group 3 (GamFluVac dose3)

EXPERIMENTAL

The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose

Biological: GamFluVac

Interventions

GamFluVac BIOLOGICAL

1 dose (0,5 ml)

Group 1 (GamFluVac dose1); Group 2 (GamFluVac dose2); Group 3 (GamFluVac dose3)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 30.
• 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);
• negative tests for HIV, hepatitis B and C, syphilis;
• negative urine test for traces of drugs;
• negative test for alcohol content in the exhaled air;
• absence of malignant blood diseases;
• absence of malignant neoplasms;

You may not qualify if:

• participation of a volunteer in any other study in the last 90 days;
• any vaccination in the last 30 days;
• vaccination against influenza within 6 months before the start of the study (including during participation in other clinical trials).
• symptoms of respiratory illness in the last 3 days;
• recent frequent nasal bleeding (\> 5 last year);
• chronic rhinitis, the presence of defects of the nasal septum, polyps of the nose or other significant anomalies;
• surgical operations or a history of nasal trauma for 6 months.
• treatment with steroids in the last 10 days;
• administration of immunoglobulins or other blood products for the last 3 months;
• taking immunosuppressive drugs and / or immunomodulators within 6 months before the start of the study;
• regular past or current use of narcotic drugs;
• pregnancy or breastfeeding;
• systolic blood pressure less than 100 mmHg or higher than 139 mmHg; diastolic blood pressure less than 60 mmHg. or above 90 mmHg; the heart rate is less than 60 beats per minute or more than 90 beats per minute;
• exacerbation of allergic diseases, the presence of anaphylactic reactions or angioedema in medical history;
• hypersensitivity or allergic reactions to the administration of any vaccine in medical history;

Sponsors & Collaborators

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

Study Sites (1)

Federal state budgetary institution " Main military clinical hospital named after academician N. N. Burdenko " of the Ministry of Defence of the Russian Federation

Moscow, 141306, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Irina Gagarina, MD, PhD

  Federal state budgetary institution " Main military clinical hospital named after academician N. N. Burdenko " of the Ministry of Defence of the Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Taking into account the fact that the drug is being studied for the first time with the participation of people, initially 5 volunteers will be hospitalized, who will receive the study drug at a dose of 1. 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), volunteers receiving the drug at a dose 2 and dose 3 will be included in the study.

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 29, 2018
• Study Start: October 15, 2018
• Primary Completion: December 24, 2018
• Study Completion: March 14, 2019
• Last Updated: March 15, 2019

Record last verified: 2018-07

Locations

RU (1)