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Sponsors and Collaborators: |
University Hospitals, Leicester Crucell Holland BV National Institute of Biological Standards and Control Health Protection Agency |
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Information provided by: | University Hospitals, Leicester |
ClinicalTrials.gov Identifier: | NCT00814229 |
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
Condition | Intervention | Phase |
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Influenza |
Biological: H9N2 whole virus vaccine, IM, 1.5microg Biological: H9N2 whole virus vaccine, IM, 5microg Biological: H9N2 whole virus vaccine vaccine, IM, 15microg Biological: H9N2 whole virus vaccine, IM, 45microg Biological: H9N2 whole virus vaccine, alum, IM, 1.5microg Biological: H9N2 whole virus, alum, IM, 5microg Biological: H9N2 vaccine, whole virus, alum, IM, 15 microg Biological: H9N2 vaccine, whole virus, alum, IM, 45microg Biological: H9N2 virosome vaccine, IM, 1.5microg Biological: H9N2 virosomal vaccine, IM, 5microg Biological: H9N2 virosomal vaccine, IM, 15microg Biological: H9N2 virosomal vaccine, IM, 45microg Biological: H9N2 whole virus vaccine, ID, 5microg Biological: H9N2 whole virus vaccine, ID, 15microg |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 360 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Vaccine 1: Active Comparator
influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection
|
Biological: H9N2 whole virus vaccine, IM, 1.5microg
influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection
|
vaccine 2: Active Comparator
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection
|
Biological: H9N2 whole virus vaccine, IM, 5microg
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection
|
Vaccine 3: Active Comparator
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection
|
Biological: H9N2 whole virus vaccine vaccine, IM, 15microg
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection
|
Vaccine 4: Active Comparator
influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection
|
Biological: H9N2 whole virus vaccine, IM, 45microg
influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection
|
Vaccine 5: Active Comparator
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg 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
|
Vaccine 6: Active Comparator
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 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
|
Vaccine 7: Active Comparator
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg 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
|
Vaccine 8: Active Comparator
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg 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
|
Vaccine 9: Active Comparator
influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection
|
Biological: H9N2 virosome vaccine, IM, 1.5microg
influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection
|
Vaccine 10: Active Comparator
influenza H9N2 vaccine virosomal containing 5microg haemagglutinin by intramuscular injection
|
Biological: H9N2 virosomal vaccine, IM, 5microg
influenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection
|
Vaccine 11: Active Comparator
influenza H9N2 vaccine virosomal containing 15microg haemagglutinin by intramuscular injection
|
Biological: H9N2 virosomal vaccine, IM, 15microg
influenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection
|
Vaccine 12: Active Comparator
influenza H9N2 vaccine virosomal containing 45microg haemagglutinin by intramuscular injection
|
Biological: H9N2 virosomal vaccine, IM, 45microg
influenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection
|
Vaccine 13: Active Comparator
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection
|
Biological: H9N2 whole virus vaccine, ID, 5microg
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection
|
Vaccine 14: Active Comparator
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection
|
Biological: H9N2 whole virus vaccine, ID, 15microg
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection
|
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Leicestershire | |
University Hospitals Leicester | |
Leicester, Leicestershire, United Kingdom, LE1 5WW |
Principal Investigator: | Karl G Nicholson, FRCP, MD | University of Leicester |
Responsible Party: | University of Leicester ( Profressor Karl Nicholson ) |
Study ID Numbers: | UHL 08162, REC 6794 |
Study First Received: | December 23, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00814229 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
influenza H9N2 vaccine |
Virus Diseases Aluminum sulfate Respiratory Tract Diseases Respiratory Tract Infections |
N-(2-aminoethyl)-5-isoquinolinesulfonamide Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
Adjuvants, Immunologic Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |