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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
50
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
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States
Geometric mean titers (GMTs) of serum HAI antibodies
Time frame: Day 1
Geometric mean titers (GMTs) of serum HAI antibodies
Time frame: Day 43
Occurrence of all SAEs
Time frame: Day 1 through Day 202
Occurrence of solicited injection site AEs
Time frame: Day 1 through Day 8
Occurrence of solicited injection site AEs
Time frame: Day 22 through Day 29
Occurrence of solicited systemic AEs
Time frame: Day 1 through Day 8
Occurrence of solicited systemic AEs
Time frame: Day 22 through Day29
Occurrence of study vaccine-related SAEs
Time frame: Day 1 through Day 202
Percentage of subjects achieving a serum HAI antibody titer of 40 or greater against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 43
Percentage of subjects achieving HAI seroconversion against study vaccine (pre-vaccination HAI titer <10 and post-vaccination HAI titer > / = 40 or pre-vaccination HAI titer > / =10 and a min 4-fold rise in post-vaccination HAI antibody titer
Time frame: Day 43
GMT of serum HAI antibody against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 22
GMT of serum Neut antibody against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 1
GMT of serum Neut antibody against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 22
GMT of serum Neut antibody against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 43
Occurrence of all unsolicited non-SAEs
Time frame: Day 1 through Day 43
Occurrence of Medically-Attended Adverse Events (MAAEs), including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Time frame: Day 1 through Day 202
Occurrence of study vaccine-related unsolicited non-serious AEs
Time frame: Day 1 through Day 43
Percentage of subjects achieving a serum HAI antibody titer of 40 or greater against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 22
Percentage of subjects achieving a serum Neut antibody titer of 40 or greater against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 1
Percentage of subjects achieving a serum Neut antibody titer of 40 or greater against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 22
Percentage of subjects achieving a serum Neut antibody titer of 40 or greater against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 43
Percentage of subjects achieving HAI seroconversion against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 22
Percentage of subjects achieving Neut seroconversion (pre-vaccination Neut titer < 10 and post-vaccination Neut titer > / = 40 or pre-vaccination Neut titer > / = 10 and a min 4-fold rise in post-vaccination Neut antibody titer)
Time frame: Day 22
Percentage of subjects achieving Neut seroconversion (pre-vaccination Neut titer < 10 and post-vaccination Neut titer > / = 40 or pre-vaccination Neut titer > / = 10 and a min 4-fold rise in post-vaccination Neut antibody titer)
Time frame: Day 43
Proportion of subjects with GMT of serum Neut antibody against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 29
Proportion of subjects with seroconversion against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 29
Proportion of subjects with titer of 40 or greater of serum HAI antibody against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 29
Proportion of subjects with titer of 40 or greater of serum Neut antibody against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 29
Secondary Proportion of subjects with GMT of serum HAI antibody against the A/H5N1 antigen contained in the study vaccine
Time frame: Day 29
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