Influenza Clinical Trial
Official title:
A Randomised Double-blind, Placebo-controlled, Phase 1b Trial to Evaluate the Safety, Tolerability and Protective Efficacy of the Influenza Vaccine Candidate, FLU-v, in an Influenza Challenge Model
The purpose of this research is to study the safety, tolerability and effectiveness of the investigational influenza vaccine in healthy volunteers infected with an attenuated influenza A virus.
The investigational influenza vaccine (FLU-v) contains multiple highly conserved T cell
epitopes that are present on most influenza viruses, which have been identified as reactive
in different human leukocyte antigen (HLA) populations; thus making it unlikely that anybody
in the vaccinated population would be unable to mount an immune response to at least one of
the epitopes contained in the vaccine.
In this study up to 44 will be vaccinated with the FLU-v experimental vaccine or a placebo
in a 1:1 ratio. Volunteers will attend a screening visit, a vaccination visit, a 10-11 day
overnight stay in a quarantine facility, and a follow-up visit to the P1 clinic.
Three weeks after being vaccinated with FLU-v or placebo, 30 volunteers will be taken to a
Quarantine Unit to be exposed to the attenuated H3N2 study virus and then monitored by study
physicians and nurses for a 10-11 day period. The other 14 volunteers will be held in
reserve as back-ups. If fewer than 30 of the volunteers who travel to the Quarantine Unit
are eligible to be exposed to the study virus, then volunteers who have been kept in reserve
will be used.
Following discharge from the Quarantine Unit, volunteers will attend one study follow-up
visit, 28 days after exposure to the study virus. Assessments will take place and samples
will be taken from volunteers.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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