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

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.

Timeline

Start

2019-08-29

Primary completion

2020-03-31

Completion

2020-03-31

Drugs

Indications