Influenza A Clinical Trial
Official title:
An Open Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac Vector Vaccine Against Influenza A in Healthy Volunteers in 3 Groups With a Dose Escalation
The present clinical phase I study designed to examine the safety, reactogenicity and immunogenicity of the medicinal product - Vaccine vector against influenza A - in healthy volunteers after a single dose in the three groups with dose escalation.
According to the results of the screening of volunteers who signed the informed consent Form,
a sequential set of three groups of volunteers with different doses of the drug, the total
number of volunteers who received the drug will be at least 36 people.
Given the fact that the drug is investigated for the first time with the participation of the
people, will initially be admitted to hospital on 5 volunteers who will receive the
investigational drug in the 1 dose The total number of recombinant pseudo-adenoviral
particles (2.5 ± 1.25) x 10*10 VP/dose). If the safety of the drug is confirmed by the
results of observation on the 7th day of the study, the study will continue with the
participation of 7 more volunteers in this dosing group.
Further, according to a similar scheme (each time after an interim safety assessment on day
7), the study will include volunteers receiving the drug at a dose of 0.5 ml (Total amount of
recombinant pseudo-adenoviral particles (1.0 ± 0.5) x 1011 VP/dose), particles/dose and 0.5
ml, -The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose
.
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