H5N1 With or Without Topical Aldara in Healthy Adults
Condition: Avian Influenza; Influenza Immunisation
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I randomized, double-blind, placebo-controlled trial in 50 males and non-pregnant
      females, 18 to 49 years old, who are in good health and meet all eligibility criteria. This
      clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of
      inactivated A/H5N1 influenza vaccine administered intradermally (ID) with topical Aldara or
      control cream as a 2-dose regimen. The vaccine will be administered using the
      MicronJet600(TM) device. Subjects will be assigned to 2 treatment arms (25 subjects per
      treatment arm). Group A will receive two doses of A/H5N1 IIV ID with pre-application of
      topical Aldara on Days 1 and 22. Group B will receive two doses of A/H5N1 IIV ID with
      pre-application of topical control cream on Days 1 and 22. The duration of this study will be
      approximately 20 months with patient participation duration approximately 7 months. The
      primary objectives of this study are: 1) to assess the safety and reactogenicity after 2
      doses of A/H5N1 IIV vaccine containing 9 mcg HA per dose administered ID approximately 21
      days apart with topical Aldara or control cream; 2) to assess the serum HAI antibody
      responses 21 days after receipt of the 2nd dose of A/H5N1 IIV administered ID at 9 mcg HA per
      dose with topical Aldara or control cream.
    

Detailed description: 
      This is a Phase I randomized, double-blind, placebo-controlled trial in 50 males and
      non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all
      eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity,
      and immunogenicity of inactivated A/H5N1 influenza vaccine administered intradermally (ID)
      with topical Aldara or control cream as a 2-dose regimen. The vaccine will be administered
      using the MicronJet600(TM) device. Subjects will be assigned randomly to 1 of 2 treatment
      arms (25 subjects per treatment arm) to receive 2 doses of A/H5N1 IIV administered ID with
      topical Aldara or control cream. Group A will receive two doses of A/H5N1 IIV (9 mcg HA/dose)
      ID with pre-application of topical Aldara on Days 1 and 22. Group B will receive two doses of
      A/H5N1 IIV (9 mcg HA/dose) ID with pre-application of topical control cream on Days 1 and 22.
      The duration of this study will be approximately 20 months with patient participation
      duration approximately 7 months. The primary objectives of this study are: 1) to assess the
      safety and reactogenicity after 2 doses of A/H5N1 IIV vaccine containing 9 mcg HA per dose
      administered ID approximately 21 days apart with topical Aldara or control cream; 2) to
      assess the serum HAI antibody responses 21 days after receipt of the 2nd dose of A/H5N1 IIV
      administered ID at 9 mcg HA per dose with topical Aldara or control cream. The secondary
      objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt
      of 2 doses of A/H5N1 IIV administered ID approximately 21 days apart with topical Aldara or
      control cream; 2) to assess medically-attended adverse events (MAAEs) including new-onset
      chronic medical conditions (NOCMCs), and potentially immune mediated medical conditions
      (PIMMCs) following receipt of two doses of A/H5N1 IIV administered ID approximately 21 days
      apart with topical Aldara or control cream for six months after last vaccination; 3) to
      assess the serum neutralizing (Neut) antibody responses 21 days following receipt of the 1st
      and 2nd dose of A/H5N1 IIV administered ID with topical Aldara or control cream; 4) to assess
      the serum HAI antibody responses 21 days following receipt of the 1st dose of A/H5N1 IIV
      administered ID with topical Aldara or control cream; 5) to assess the serum HAI and Neut
      antibody responses 7 days following receipt of the 2nd dose of A/H5N1 IIV administered ID
      with topical Aldara or control cream.
    

Intervention name(s): Aqueous Cream B.P.; Imiquimod; Influenza Virus Vaccine, Monovalent A/H5N1 A/Vietnam/1203/04
Intervention type(s): Other; Drug; Biological
Intervention description(s): Aqueous Cream B.P. will be used as the control cream. An equivalent of 250mg of the cream will be applied and rubbed into the skin until it vanishes, on the deltoid area 5-15 minutes prior to vaccine administration.; Aldara (imiquimod 5%) cream is an immune response modifier for topical administration. 250 mg of the cream, equivalent to 12.5 mg of imiquimod will be applied and rubbed into the skin until it vanishes, on the deltoid area 5-15 minutes prior to vaccine administration.; Inactivated monovalent subvirion H5N1 vaccine containing hemagglutinin (HA) of A/Vietnam/1203/04
Intervention MeSH terms: Imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy Young Adults; Immunogenicity; Inactivated Influenza A/H5N1 Vaccine; Phase I Clinical Trial; Reactogenicity; Safety; Topical Aldara(R)