Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the body's reactions and immune responses after
      receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant
      given into the arm muscle. Study participants will include up to 96 healthy adults, ages
      18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the
      following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be
      vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for
      7 days following each vaccination. Participants will return to the clinic on days 2 and 7
      after vaccination. Blood samples will be collected 7 days following each vaccination. Serum
      and nasal wash specimens will be collected before each vaccination and 4 weeks after
      injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for
      up to 8 months.
    

Detailed description: 
      The primary goal of this study is to assess the safety of 4 different dosages of purified
      monovalent surface antigen (SA) influenza A/H9N2 virus vaccine with or without MF59 adjuvant
      and administered intramuscularly to ambulatory adults. The hypothesis is that all dosage
      levels of adjuvanted and nonadjuvanted vaccine will be well tolerated. The primary objective
      of this project is to evaluate the safety of 4 dosage levels of monovalent surface antigen
      (SA) influenza A/H9N2 virus vaccine given with or without MF59 adjuvant. The primary endpoint
      is the frequency and severity of solicited local and systemic adverse events in each vaccine
      dosage level group. The secondary objective of this project is to determine the
      immunogenicity of 4 dosage levels of monovalent surface antigen (SA) influenza A/H9N2 virus
      vaccine given with or without MF59 adjuvant. The secondary endpoints include the following:
      the proportions of subjects in each vaccine dosage group that achieve a serum HAI titer of at
      least 1:32 one month after the second vaccination; the geometric mean titer (GMT) of serum
      HAI antibody against the influenza A/H9N2 virus one month after the second vaccination; the
      rates of significant increases in titer between pre- and post-immunization serum samples
      (defined as seroconversion-i.e., increase in titer from <1:4 pre-immunization to at least 1:8
      after vaccination, or 4-fold or greater increase in titer between pre- and post-immunization
      samples) 28 days after each vaccination (days 28 and 56); and the proportion of subjects with
      a 4-fold or greater increase in percent HA-specific antibody in nasal wash specimens for each
      vaccine group. The study will be a double-blind evaluation of 4 dosage levels of study
      vaccine. The 4 dosage levels to be tested are 3.75-, 7.5-, 15-, and 30-mcg of HA of the
      vaccine strain with and without MF59 adjuvant. Because all dosage levels are lower than the
      total hemagglutinin content of the FLUAD® vaccine used in Europe, subjects will be enrolled
      into all dosage and adjuvant groups concurrently using a randomized, double-blind study
      design. Ninety-six persons 18-34 years of age will be enrolled. A single lot of monovalent
      inactivated SA influenza A/H9N2 vaccine will be used throughout the trial. All injections
      will be administered in a 0.5-mL volume into the deltoid muscle. Screening and safety
      laboratory examinations will be assessed before the first dose and 7 days after each
      vaccination. Assessments for reactogenicity will be done for at least 20 minutes after each
      vaccination, in the clinic 2 and 7 days after each inoculation, via diary card for seven days
      after each vaccination, and via phone or other contact at 7 months after the first
      vaccination for any serious adverse events during the entire study period. Serum and nasal
      wash samples collected on days 0, 28, and 56 will be used to measure immunogenicity of the
      vaccine preparation. Participants will be involved in study related procedures for up to 8
      months.
    

Intervention name(s): Influenza A/H9N2 vaccine; MF59 adjuvant
Intervention type(s): Biological; Drug
Intervention description(s): A single lot of monovalent inactivated SA influenza A/H9N2 vaccine. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Dosage levels are: 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant.; MF59 adjuvant is an oil-in-water emulsion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza, vaccine, A/H9N2, MF59, adjuvant