H5N1 (Clade 2) Vaccination of Adults and Elderly

Influenza Clinical Trial

Official title: A Randomized, Double-Blinded, Phase I/II Study of the Safety, Reactogenicity, and Immunogenicity of an Inactivated Influenza Vaccine Derived From A/H5N1/Indonesia/05/05 (Clade 2) in Healthy Adults and Elderly Who Participated in a Previous A/H5N1/Vietnam/1203/2004 (Clade 1) Vaccine Study

Status Completed

Clinical Trial Summary

The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.

Clinical Trial Description

The goals of this study are to investigate the safety, reactogenicity, and immunogenicity of a single dose of monovalent subvirion influenza vaccine produced from a clade 2 A/H5N1 vaccine administered by intramuscular injection to healthy adults and the elderly who have previously received at least 2 doses of clade 1 A/H5N1 vaccine. In addition, this study will compare these results to individuals who are receiving 2 doses of the clade 2 A/H5N1 vaccine for the first time. The primary objective of the study is to compare the immune response following a single low-dose (15 mcg) to a single high-dose (90 mcg) of influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04). The secondary objectives will: compare the immune response following a single low-dose (15 mcg) or single high-dose (90 mcg) of influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04) to a group that has not received any previous A/H5N1 vaccine but who will receive 2 doses of an influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05; evaluate the factors associated with immunologic response to a single dose of a vaccine derived from a clade 2 virus among individuals who have previously received at least 2 doses of vaccine derived from a clade 1 virus; evaluate the safety of a single dose of subvirion inactivated vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04); explore immunologic responses following vaccination with a clade 2 vaccine from A/H5N1/Indonesia/05/05 to influenza strains other than A/H5N1/Indonesia/05/05, including A/VN/1203/04; evaluate the immune responses of previously unvaccinated individuals after 1 or 2 doses of clade 2 virus A/H5N1/Indonesia/05/05 vaccine; and evaluate the duration of antibody responses following 1 or 2 doses of vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05. This study will recruit 600 healthy volunteers aged 19 years or older, in the United States, who have previously participated in a linked DMID-sponsored study. This study is linked to DMID protocols 04-063, 05-0090, 04-076, 05-0015, 05-0127, 05-0141, 06-0089, 04-062, 06-0052, and 08-0030. The study will be conducted at up to 7 vaccine centers. Subjects who previously received at least 2 doses of the clade 1 vaccine derived from the A/H5N1/Vietnam/1203/2004 virus will be randomized to receive a single dose of either 15 mcg or 90 mcg of a clade 2 vaccine derived from the A/H5N1/Indonesia/05/05 virus in a 1:1 ratio. H5 naïve subjects who previously received at least 2 doses of a placebo will be randomized to receive 2 doses of either the 15 mcg or 90 mcg of a clade 2 vaccine derived from the A/H5N1/Indonesia/05/05 virus in a 1:1 ratio. Volunteers will be observed in the clinic for 15 minutes after inoculation, and will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 8 days following each vaccination. Volunteers will be contacted by telephone 1 to 3 days after each vaccination to assess for the occurrence of AEs, and they will return to the clinic 8-10 days after each vaccination for AE and concomitant medication assessment, a targeted physical examination (if indicated), and review of the memory aid. T ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT00680069
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2008
• Completion date: November 2009