A Double-blind Randomized Placebo-controlled Study Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac

NCT04034290 | Completed Phase 2

• 1 other identifier: 03 - GamFluVac-2019
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination

Conditions

Healthy Volunteers

Keywords

influenza; vaccine; Immunologic Factors; Respiratory Tract Infections; vector vaccines

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  Determination of Number of Participants With Adverse Events

  through the whole study, an average of 180 days

• Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)

  Determination of antibody levels measured by an ELISA vs. baseline values and vs placebo

  through the whole study, an average of 90 days

Secondary Outcomes (1)

• Assessment of antigen-specific cell-mediated immune response

  at days 0 and 7

Study Arms (4)

Stage 1 (GamFluVac intranasal drip)

EXPERIMENTAL

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

Biological: GamFluVac

Stage 1 (GamFluVac with the help of a spray dispenser)

EXPERIMENTAL

The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated intranasally with the help of a spray dispenser

Biological: GamFluVac

Stage 2 Vaccine

EXPERIMENTAL

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

Biological: GamFluVac

Stage 2 (Controll Group)

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

GamFluVac BIOLOGICAL

The drug is a vaccine that induces high-level immunity against influenza A viruses

Stage 1 (GamFluVac intranasal drip); Stage 1 (GamFluVac with the help of a spray dispenser); Stage 2 Vaccine

Placebo OTHER

Placebo

Stage 2 (Controll Group)

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
• Main military clinical hospital named after academician N. N. Burdenko: collaborator

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, Russia

Location

MeSH Terms

Conditions

Influenza, Human; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This clinical trial on the second stage is designed as a double blind randomized placebo-controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: October 18, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2020
• Last Updated: August 25, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)