NCT04650971

Study to Assess Safety, Tolerability and Reactogenicity of Vaccine "UniFluVec" After Two Intranasal Administrations in Healthy Volunteers

Phase I Randomized Double Blind Placebo-controlled Study of Universal Influenza Vector Vaccine "UniFluVec" of Two Dose Levels After Two Intranasal Administrations in Healthy Volunteers at the Age From 18 to 49 Years Old

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pharmenterprises Biotech LLC · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza A

Interventions

Type	Name	Description
BIOLOGICAL	UniFluVec	Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks
BIOLOGICAL	Placebo	Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks

Timeline

• Start date: 2019-08-29
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

1 site across 1 country: Russia