NCT00814229

Safety and Immunogenicity of Influenza H9 Vaccine in Humans

Randomised Dose Ranging Observer Blind Single Centre Study to Evaluate Safety and Immunogenicity of Adjuvanted and Non-adjuvanted Influenza H9 Influenza Vaccine in Humans

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: University Hospitals, Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H9N2 whole virus vaccine, IM, 1.5microg	influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 whole virus vaccine, IM, 5microg	influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 whole virus vaccine vaccine, IM, 15microg	influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 whole virus vaccine, IM, 45microg	influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 whole virus vaccine, alum, IM, 1.5microg	influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 whole virus, alum, IM, 5microg	influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 vaccine, whole virus, alum, IM, 15 microg	influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 vaccine, whole virus, alum, IM, 45microg	influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 virosome vaccine, IM, 1.5microg	influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 virosomal vaccine, IM, 5microg	influenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 virosomal vaccine, IM, 15microg	influenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 virosomal vaccine, IM, 45microg	influenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection
BIOLOGICAL	H9N2 whole virus vaccine, ID, 5microg	influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection
BIOLOGICAL	H9N2 whole virus vaccine, ID, 15microg	influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-01-01
• Completion: 2008-09-01
• First posted: 2008-12-24
• Last updated: 2009-07-21

Locations

1 site across 1 country: United Kingdom