H5N1 With or Without Topical Aldara in Healthy Adults
Status:
Completed
Trial end date:
2019-03-04
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)