Study to Assess Safety, Tolerability and Reactogenicity of Vaccine "UniFluVec" After Two Intranasal Administrations in Healthy Volunteers
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety,
      tolerability, reactogenicity and immunogenic activity of the universal influenza vector
      vaccine "UniFluVec" at two dose levels after two intranasal administrations in healthy
      adults. The volunteers randomized to the study group received intranasally 0.5 ml of the
      vaccine (0.25 ml in each nostril) as nasal aerosol stray twice with an interval of 3 weeks.
      The vaccine of the first dose level contained 6.7 log EID50/0.5 ml (50% egg infective dose)
      of attenuated recombinant influenza A/H1N1pdm09 virus; vaccine of the second dose level
      contained 7.7 log EID50/0.5 ml of attenuated recombinant influenza A/H1N1pdm09 virus.

      The primary objective of the study was to evaluate the safety, tolerability and
      reactogenicity profile of vaccine "UniFluVec" based on the frequency and severity of adverse
      events. The secondary objective of the study was to assess the immunogenicity.
    

Detailed description: 
      One center located in Russia (Saint-Petersburg) was approved for participation in this study.
      The study consisted of 3 periods: screening, double vaccination with an interval of 3 weeks
      and follow-up.

      All eligible subjects were randomized into the study in appropriate cohort groups
      sequentially. Randomization was performed within each cohort in ratio 2:1 to the vaccine and
      placebo groups, respectively:

        -  Cohort 1 (total 30 volunteers) - 20 volunteers received the vaccine twice, 6.7 log
           EID50/dose; 10 volunteers received Placebo twice.

        -  Cohort 2 (total 30 volunteers) - 20 volunteers received the vaccine twice, 7.7 log
           EID50/dose; 10 volunteers received Placebo twice.

      The decision to administer the second dose of vaccine or increased vaccine dose (cohort 2)
      was approved by the Data Safety Monitoring Committee on the basis of preliminary safety
      results assessment.

      The follow-up period lasted 3 months after the second vaccination.
    

Intervention name(s): UniFluVec; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks; Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The dose cohorts were included into the study based on evaluation of the safety results performed by the Data Safety Monitoring Committee. 2 doses of vaccine/placebo were used in the study. The volunteers randomized to the study group received intranasally 0.5 ml of the vaccine/placebo (0.25 ml in each nostril) as nasal aerosol stray twice with an interval of 3 weeks.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy volunteers; Vector vaccine; UniFluVec