H5N1 Vaccine Intramuscular Versus Intradermal in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to compare how the body reacts to different strengths
      of an H5N1 flu vaccine when given by different routes of injection (injection into the skin
      or into the muscle). It will also compare how antibodies (proteins produced by the body's
      immune system that recognize and help fight infections and other foreign substances in the
      body) are made after receiving the H5N1 flu vaccine. Participants will include 100 healthy
      adults, ages 18-40 years. Study procedures include blood samples and completing a memory aid
      documenting daily oral temperature and side effects for 7 days following each vaccination.
      Participants may be involved in the study for up to 13 months.
    

Detailed description: 
      This is a single-center, randomized, open-label, dose-ranging, phase I comparative trial of
      intradermal (ID) and intramuscular (IM) injection with subvirion inactivated influenza A/H5N1
      vaccine in healthy adults, 18 to 40 years old, inclusive. This study is designed to
      investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational
      inactivated influenza A/H5N1 virus vaccine given by ID injection compared to IM injection.
      The primary objectives of this study are to: compare dose-related safety and reactogenicity
      profiles of ID and IM injection with subvirion inactivated influenza A/H5N1 vaccine among
      healthy young adults; compare the dose-related immunogenicity of subvirion inactivated
      influenza A/H5N1 vaccine given by ID with vaccine given by IM injection among healthy young
      adults 1 month after receipt of the second dose of vaccine; and provide information for the
      selection of the best dose levels for further studies. The secondary objectives of this study
      are to: evaluate dose-related immunogenicity and the percent of subjects responding
      approximately 1 and 7 months after the first vaccination; and evaluate the dose-related
      safety, reactogenicity and immunogenicity following receipt of a third dose of vaccine
      administered 6-7 months after the second dose of vaccine. The study will have 2 comparison
      arms (IM and ID), and 2 dosage levels will be evaluated in each arm (4 vaccine groups total).
      Subjects will be randomized 1:1:1:1 (25 subjects in each group) to receive 2 doses 1 month
      apart of an inactivated influenza A/H5N1 vaccine containing 15 mcg or 45 mcg of H5 HA by the
      IM route; or one-fifth of the IM dose (3 mcg or 9 mcg) by the ID route. Subjects will
      maintain a memory aid recording oral temperature, and systemic and local adverse events for 7
      days after each inoculation. Serum for immunogenicity evaluations will be obtained prior to
      first vaccination, at Day 0, prior to second vaccination, at Day 28, and on Day 56 and
      approximately Day 215 (7 months) after dose 1. This study is linked to DMID protocol 07-0022.
    

Intervention name(s): Inactivated Influenza A Vaccine A/H5N1; Inactivated Influenza A Vaccine A/H5N1
Intervention type(s): Biological; Biological
Intervention description(s): Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.; Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza, pandemic, H5N1, vaccine