Influenza Clinical Trial
Official title:
Randomised Dose Ranging Observer Blind Single Centre Study to Evaluate Safety and Immunogenicity of Adjuvanted and Non-adjuvanted Influenza H9 Influenza Vaccine in Humans
H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in
children. Influenza H9N2 poses a pandemic threat to humans.
This study evaluates the safety and immunogenicity of adjuvanted and non-adjuvanted whole
virus and virosomal H9N2 vaccines by the intramuscular route. We also assess intradermal
route of administration to see if this has any advantages. The aim is to assess antibody
responses before and after vaccination. The hypothesis is that lower doses of adjuvanted
vaccine will induce similar antibody responses to non-adjuvanted vaccine
A double-blind, single centre comparative study in which fourteen groups of 40 male and female adults >18 years of age will be randomly allocated to receive 1.7, 5, 15 or 45 µg quantities of whole virion (WV), Aluminium -adjuvanted WV(Al-WV), and virosomal (V) influenza A/Hong Kong/1073/99 (H9N2) vaccines by intramuscular injection into the deltoid muscle; or 5 or 15microg WV vaccine administered by intradermal injection. A second dose of the same vaccine containing the same quantity of antigen as in the first dose will be administered 21 days later. Subjects will be observed for local and systemic reactions for 30 minutes after each immunisation (day 0 and 21), and will be monitored for any reactions and other adverse events for 7 days after immunisation. Blood for immunogenicity studies will be obtained at day 0 (pre-immunisation), day-21 (+4 days), and at day-42 (i.e., 21 +4 days after the second immunization). Immunogenicity will be evaluated by haemagglutination inhibition, virus neutralization,, single radial haemolysis, neuraminidase inhibition and cellular mediated responses (in a subset of 5-10 subjects from each group). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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