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H5N1 (Clade 2) Vaccination of Adults and Elderly

2014-11-19 05:37:07 | BioPortfolio

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.

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

Conditions

Influenza

Intervention

Influenza A/H5N1/Indonesia/05/05 (clade 2) inactivated vaccine

Location

Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases
Stanford
California
United States
94305-2200

Status

Completed

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-11-19T05:37:07-0500

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Medical and Biotech [MESH] Definitions

A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 5 and neuraminidase 1. The H5N1 subtype, frequently referred to as the bird flu virus, is endemic in wild birds and very contagious among both domestic (POULTRY) and wild birds. It does not usually infect humans, but some cases have been reported.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.

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