H5N1 Vaccine Intramuscular Versus Intradermal in Healthy Adults

Influenza Clinical Trial

Official title: A Randomized, Open-Label, Phase I Clinical Trial Comparing the Safety, Reactogenicity, and Immunogenicity of Immunization With Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route Among Healthy Adults

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT00310206
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: July 2005
• Completion date: October 2006