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

Phase 2

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Placebo; Biological: GamFluVac

• Registration Number: NCT04034290
• Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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

Detailed Description

In the first stage estimate of safety of vaccine after its single administration to the nasal cavity by the drip method or by spray - dispenser during the period of observation in 30 days with the participation of 24 volunteers, divided into 2 groups of 12 people for each method of administration

After interim analysis of safety data is subject to the consent of the local ethics Committee of the Research Centre about the possibility of further studies of the drug - will be started the second phase of the study, which, along with continued security research, provides the definition of the parameters of immunogenicity of the study drug. The second phase of the study will included 200 participants, including 100 people will receive the study drug and 100 will be a control group of observation - that is, will get a placebo.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Study Start: 2019-10-18
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-31
• Last Update Submitted: 2020-08-23
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 2 (Controll Group)	Placebo	Placebo
Stage 1 (GamFluVac intranasal drip)	GamFluVac	The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated by intranasal drip
Stage 1 (GamFluVac with the help of a spray dispenser)	GamFluVac	The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated intranasally with the help of a spray dispenser
Stage 2 Vaccine	GamFluVac	The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	through the whole study, an average of 180 days	Determination of Number of Participants With Adverse Events
Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)	through the whole study, an average of 90 days	Determination of antibody levels measured by an ELISA vs. baseline values and vs placebo

Secondary Outcome Measures

Name	Time	Method
Assessment of antigen-specific cell-mediated immune response	at days 0 and 7	determination of specific T-cell- mediated response vs. baseline values ans vs placebo

Trial Locations

Locations (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, Russian Federation