NCT03472976

H5N1 With or Without Topical Aldara in Healthy Adults

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Inactivated Influenza A/H5N1 Vaccine Administered Intradermally With or Without Topical Aldara(R) in Healthy Young Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Avian Influenza
• Influenza Immunisation

Interventions

Type	Name	Description
OTHER	Aqueous Cream B.P.	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.
DRUG	Imiquimod	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.
BIOLOGICAL	Influenza Virus Vaccine, Monovalent A/H5N1 A/Vietnam/1203/04	Inactivated monovalent subvirion H5N1 vaccine containing hemagglutinin (HA) of A/Vietnam/1203/04

Timeline

• Start date: 2018-06-13
• Primary completion: 2019-03-04
• Completion: 2019-03-04
• First posted: 2018-03-21
• Last updated: 2020-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study