Higher Dose Intradermal H5 Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle
      versus injection in the skin in healthy adults. The study will look at the safety of the
      injections, how the body reacts, and what the body's immune response does when the vaccine is
      given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages
      18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart,
      physical exams, follow-up clinic visits to check the places on the body where each vaccine
      was given, and blood sample collections. Volunteers will complete a memory aid by writing
      down temperatures and health changes for 7 days after each vaccination. Volunteers will be
      involved in the study for up to 241 days.
    

Detailed description: 
      Influenza A viruses have the potential to cause worldwide epidemics and/or pandemics
      resulting in significant morbidity and mortality. Two-hundred twenty-six healthy male and
      female subjects aged 18 to 49 years, inclusive, in the United States (US) will be enrolled
      into this single-center, randomized, double-blinded, placebo-controlled trial of intradermal
      (ID) and intramuscular (IM) injection with subvirion (SV) inactivated influenza A/H5N1
      vaccine. The study will have two vaccine groups. Vaccine group 1: the subject will receive
      0.1 mL of H5 Hemagglutination (HA) by the ID route in one arm and 0.1 mL of saline placebo by
      the IM route in the other arm. Vaccine group 2: the subject will receive 0.1 mL of H5 HA by
      the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm. All
      eligible subjects will be enrolled and randomized 1:1 (113 subjects per vaccine group) to
      either vaccine group 1 or vaccine group 2. All subjects will receive two doses of
      approximately 30micrograms of H5 HA by their assigned route, either IM or ID, separated by
      approximately 28 days. At each vaccination visit, all subjects will also receive a saline
      placebo in the opposite arm by the different route as their vaccine route (i.e. if vaccine is
      administered by the ID route in one arm, then a saline placebo will be administered by the IM
      route in the opposite arm). The second vaccine dose will be administered by the same route as
      per vaccine group assigned at original randomization. Subjects will be observed in the clinic
      for approximately 15 minutes after each vaccination. Subjects will return on Day 2 for arm
      check and assessment of adverse events. All subjects will maintain a memory aid recording
      oral temperature, and systemic and local adverse events for 7 days after each vaccination.
      They will return to clinic on Day 8 for adverse event (AE) assessment, concomitant medication
      assessment, a targeted physical exam (if indicated), and review of memory aid. AE data will
      be captured Day 0 through Day 56. Serious AE data will be captured from Day 0 through the end
      of each subject's participation in the study (approximately 7 months). The subjects, staff
      assessing subjects, and lab personnel will be blinded. Serum for immunogenicity evaluations
      will be obtained prior to the first vaccination, at Day 0; prior to the second vaccination,
      at Day 28; on Day 56 and approximately Day 208 (7months after dose 1). The primary objectives
      are to compare the immunogenicity of a similar dosage level of a subvirion inactivated
      influenza A/H5N1 vaccine given by ID or IM injection one month after receipt of the second
      dose of vaccine and to compare the safety and reactogenicity of ID and IM immunization at a
      similar dosage level of a subvirion inactivated influenza A/H5N1 vaccine among healthy young
      adults. The secondary objective is to evaluate serum antibody responses approximately 1 and 7
      months after the first vaccination. This study is linked to Division of Microbiology and
      Infectious Diseases protocol 07-0022.
    

Intervention name(s): Inactivated Influenza A Vaccine A/H5N1; Inactivated Influenza A Vaccine A/H5N1; Placebo (IM); Placebo (ID)
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intramuscular (IM) injection. Vaccine will be administered to each subject at Days 0 and 28.; Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intradermal (ID) injection. Vaccine will be administered to each subject at Days 0 and 28.; The placebo will be 0.1 mL of saline administered by the IM route.; The placebo will be 0.1 mL of saline administered by the ID route.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza, vaccine, A/H5N1