H5N1 (Clade 2) Vaccination of Adults and Elderly
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to study the safety and effectiveness of vaccinating
      individuals who have previously received an avian influenza vaccine derived from one type of
      H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second
      reason for this study is to compare responses in people who have received two different but
      similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the
      H5N1 vaccine used in this study. The information obtained may provide important information
      into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy
      adult volunteers, ages 19 and older, in the United States. Study procedures include: physical
      exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of
      vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side
      effects. Study participation will be approximately 7 months.
    

Detailed description: 
      The goals of this study are to investigate the safety, reactogenicity, and immunogenicity of
      a single dose of monovalent subvirion influenza vaccine produced from a clade 2 A/H5N1
      vaccine administered by intramuscular injection to healthy adults and the elderly who have
      previously received at least 2 doses of clade 1 A/H5N1 vaccine. In addition, this study will
      compare these results to individuals who are receiving 2 doses of the clade 2 A/H5N1 vaccine
      for the first time. The primary objective of the study is to compare the immune response
      following a single low-dose (15 mcg) to a single high-dose (90 mcg) of influenza vaccine
      derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously
      received at least 2 doses of an influenza vaccine derived from the clade 1 virus
      A/H5N1/Vietnam/1203/2004 (A/VN/1203/04). The secondary objectives will: compare the immune
      response following a single low-dose (15 mcg) or single high-dose (90 mcg) of influenza
      vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have
      previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus
      A/H5N1/Vietnam/1203/2004 (A/VN/1203/04) to a group that has not received any previous A/H5N1
      vaccine but who will receive 2 doses of an influenza vaccine derived from the clade 2 virus
      A/H5N1/Indonesia/05/05; evaluate the factors associated with immunologic response to a single
      dose of a vaccine derived from a clade 2 virus among individuals who have previously received
      at least 2 doses of vaccine derived from a clade 1 virus; evaluate the safety of a single
      dose of subvirion inactivated vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05
      in individuals who have previously received at least 2 doses of an influenza vaccine derived
      from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04); explore immunologic responses
      following vaccination with a clade 2 vaccine from A/H5N1/Indonesia/05/05 to influenza strains
      other than A/H5N1/Indonesia/05/05, including A/VN/1203/04; evaluate the immune responses of
      previously unvaccinated individuals after 1 or 2 doses of clade 2 virus
      A/H5N1/Indonesia/05/05 vaccine; and evaluate the duration of antibody responses following 1
      or 2 doses of vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05. This study will
      recruit 600 healthy volunteers aged 19 years or older, in the United States, who have
      previously participated in a linked DMID-sponsored study. This study is linked to DMID
      protocols 04-063, 05-0090, 04-076, 05-0015, 05-0127, 05-0141, 06-0089, 04-062, 06-0052, and
      08-0030. The study will be conducted at up to 7 vaccine centers. Subjects who previously
      received at least 2 doses of the clade 1 vaccine derived from the A/H5N1/Vietnam/1203/2004
      virus will be randomized to receive a single dose of either 15 mcg or 90 mcg of a clade 2
      vaccine derived from the A/H5N1/Indonesia/05/05 virus in a 1:1 ratio. H5 naïve subjects who
      previously received at least 2 doses of a placebo will be randomized to receive 2 doses of
      either the 15 mcg or 90 mcg of a clade 2 vaccine derived from the A/H5N1/Indonesia/05/05
      virus in a 1:1 ratio. Volunteers will be observed in the clinic for 15 minutes after
      inoculation, and will maintain a memory aid to record oral temperature and systemic and local
      adverse events (AEs) for 8 days following each vaccination. Volunteers will be contacted by
      telephone 1 to 3 days after each vaccination to assess for the occurrence of AEs, and they
      will return to the clinic 8-10 days after each vaccination for AE and concomitant medication
      assessment, a targeted physical examination (if indicated), and review of the memory aid. T
    

Intervention name(s): Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005
Intervention type(s): Biological
Intervention description(s): Inactivated monovalent subvirion influenza A/H5N1/Indonesia/05/05 (clade 2) vaccine administered via intramuscular injection. Low Dose Group will receive 15 mcg intramuscularly (IM), High Dose Group will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will receive 1 dose, clade 1 vaccine-naive subjects will receive 2 doses 28 days apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: avian influenza,H5N1,Influenza,parent protocol