Influenza Clinical Trial
Official title:
Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model
A study to compare multiple dosage regimes of a protesomal intranasal vaccine.
A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered
intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both
systemic and mucosal compartments - and effective at preventing influenza illness.
In two separate studies using the Human Viral Challenge Model, subjects were selected for
susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens:
(A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or
B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days
apart, before subjects were challenged with ~8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2)
virus. Immune responses to the vaccine antigens were measured, namely serum IgG (via the
aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via
ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after
viral challenge and compared.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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