Influenza Clinical Trial
Official title:
A Single Centre, Randomised, Double Blind, Phase 1 Study of the Safety, Tolerability, and Immunogenicity of an Influenza Vaccine Candidate (FLU-v)
The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response.
Prophylactic vaccination against influenza is indicated for "at risk" populations including
patients suffering from chronic respiratory diseases (including asthma), chronic heart
disease, chronic renal failure, diabetes mellitus and immunosuppression due to disease or
treatment. Vaccination of the elderly (>65 years) and the residents of nursing homes is also
recommended. The current influenza vaccines available contain subunits from two influenza A
viruses and an influenza B virus and consist either of inactivated whole virus or subunits
of haemagglutinin and neuraminidase.
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.
This study will be the initial exploration of FLU-v in humans, and aims to assess the
safety, tolerability, and immunogenicity in healthy subjects.
Subjects will be randomised to receive either Low Dose or High Dose FLU-v with or without
adjuvant, or placebo with or without adjuvant. Twenty-four (24) subjects will be randomized
to Low Dose and 24 subjects to High Dose. To mitigate risk, a staggered dosing approach will
be used. One subject will receive Low Dose FLU-v without adjuvant, and one subject will
receive placebo without adjuvant, followed 6 hours later by one subject receiving Low Dose
FLU-v with adjuvant, and one subject receiving placebo with adjuvant. All 4 subjects will be
observed overnight. At least 72 hours later and in the absence of any clinically-significant
safety signals (as determined by a Safety Review Committee) the remaining 20 subjects of the
Low Dose group will be dosed. If deemed appropriate by the Safety Review Committee a second
sentinel cohort of 4 subjects will be observed overnight prior to completing the remaining
subjects of the Low Dose group. Following a satisfactory review of safety data from the
combined Low Dose cohorts, subjects in the High Dose group will be vaccinated using the same
staggered dosing approach as used in Low Dose.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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