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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
353
influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection
University Hospitals Leicester
Leicester, Leicestershire, United Kingdom
Geometric mean antibody titres of antibody to influenza H9 by HI and neutralising antibody assays
Time frame: Pre vaccination, 21 days and 42 days
Local and systemic reactogenicity of influenza H9 vaccine
Time frame: within 7 days of vaccination
seroprotective antibody titres to influenza H9 by HI and neutralising antibody
Time frame: pre vacciantion, 21 and 42 days post-vaccine
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influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection