Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, any adverse events or side effects, and
      the body's immune response to an experimental flu vaccine [Inactivated Influenza A/H7N7
      Vaccine] being given in increasing doses. Researchers will try to find the smallest dose of
      flu vaccine needed to cause antibody responses against the flu virus in both single and
      repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years
      old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will
      include obtaining a medical history, physical exam, blood sample collections, and use of
      patient memory aids. The volunteers will be in the study for about 7 months.
    

Detailed description: 
      This randomized, double-blinded, placebo-controlled, dose-ranging, Phase I/II, influenza
      study will compare the safety, reactogenicity, and immunogenicity of increasing doses of
      monovalent subvirion influenza A/H7N7 virus vaccine administered by intramuscular (IM)
      injection to healthy adults. A total of 125 healthy adults ranging from 18 to 40 years old
      will be enrolled at one site for this study. The subjects will be randomized to receive
      saline placebo or 7.5, 15, 45, or 90 mcg of the influenza A/H7N7 vaccine by intramuscular
      (IM) injection in an approximate 1:1:1:1:1 ratio (N=25/vaccine dose group and 25 in the
      placebo group). Subjects will receive 2 doses separated by approximately 28 days. Subjects
      will be observed in the clinic for a minimum of 30 minutes after inoculation. All subjects
      will maintain a memory aid to record oral temperature and systemic and local adverse events
      (AEs) for 7 days after each immunization. Subjects will be contacted by telephone 1-3 days
      after vaccination to assess for the occurrence of AEs, and they will return to the clinic
      between Day 8 and 12 for AE and concomitant medication assessment, a targeted physical
      examination (if indicated), and review of the memory aid. Serum for immunogenicity
      evaluations will be obtained for subjects prior to the first vaccination, at Day 28 prior to
      the second vaccination, and on Days 56 and 208. A Safety Monitoring Committee (SMC) will
      review available 7 day safety data at approximately Day 20 following the first subject
      vaccination before administering the second dose of vaccine to any subjects. The primary
      objectives of the study will be: to determine the dose-related safety of subvirion
      inactivated H7N7 vaccine in healthy adults; to determine the dose-related immunogenicity of
      subvirion inactivated H7N7 vaccine in healthy adults approximately 1 month following receipt
      of 2 doses of vaccine; and to provide information for the selection of the best dose levels
      for further studies. The secondary objective will be to evaluate the dose-related
      immunogenicity and the percent of subjects responding approximately 1 and 7 months after the
      first vaccination. The primary endpoints are: adverse event (AE) or serious adverse event
      (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and
      periodic targeted physical assessment); the proportion of subjects in each dose group
      achieving a serum neutralizing antibody titer of greater than or equal to 40 against the
      influenza A/H7N7 virus 28 days after receipt of the second dose of vaccine (approximately Day
      56); geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing
      antibody titers in each group 1 month after receipt of each dose, and 7 months after receipt
      of the first dose of vaccine; and GMT and frequency of 4-fold or greater increases in serum
      hemagglutination inhibition (HAI) antibody titers in each group 1 month after receipt of each
      dose, and 7 months after receipt of the first dose of vaccine. Participants will be involved
      in study related procedures for approximately 7 months. This study is linked to DMID protocol
      07-0060.
    

Intervention name(s): Influenza A/H7N7 Vaccine; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Monovalent subvirion H7N7 vaccine, 4 dose levels of vaccine, each subject will receive 2 doses (7.5, 15, 45, or 90 micrograms); the same dose will be given at Day 0 and Day 28.; Sterile normal saline for injection (0.9%); 0.5 ml volume sodium chloride injection. Subjects will receive 2 doses on Day 0 and Day 28.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza, inactivated influenza A/H7N7 vaccine, parent protocol