T and B Cell Response to Avian Flu Vaccine

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00337896
First received: June 15, 2006
Last updated: August 15, 2013
Last verified: April 2011
  Purpose

The purpose of this substudy study is to evaluate the types of cells involved in fighting infection to the A/H5N1 (avian flu virus) vaccine. A maximum of 30 healthy adults ages 18-64 years, enrolled at Stanford University Hospital and participating in another clinical trial (DMID Protocol 04-062) will be enrolled into this substudy to collect additional samples of blood for testing before and approximately one week after each vaccination.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: T and B Cell Immune Responses to Influenza A/H5N1 Vaccine

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples Without DNA

blood


Estimated Enrollment: 30
Study Start Date: March 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
observation
healthy adults ages 18-64 years, enrolled at Stanford University Hospital and participating in another clinical trial (DMID Protocol 04-062)

Detailed Description:

A human vaccination trial involving influenza A/H5N1 vaccine with different adjuvants is being conducted in a healthy adult population aged 18-64 years (DMID 04-062) to test the safety, reactogenicity, and immunogenicity of monovalent inactivated influenza A/H5N1 vaccine when given with either alone (no adjuvant), or given along with either alum or MF59. Two doses of the vaccine/adjuvent will be administered day 0 and day 28. This study is linked to DMID protocol 04-062. This protocol is a substudy to collect additional blood samples to specifically evaluate the cell-mediated immune responses generated from the vaccine. Primary goals of this study are 1) to establish reproducible, functional cell-mediate immune response assays to evaluate the magnitude and functional capacity of B cells, NK cells and T cells responding to monovalent subvirion H5 influenza vaccine 2) to evaluate the percent of subjects demonstrating B cell, NK cell, CD8+ and/or CD4+ response. The secondary goal of this study is to examine and compare the adjuvant effect of Alum or MF59 compared to no adjuvant on cell mediated immune responses.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy adults male and female ages 18-64 years, participating in another clinical trial (DMID Protocol 04-062)

Criteria

Inclusion Criteria:

  1. All subjects who are eligible and enrolled in 04-062 and have agreed to the extra blood draws for this substudy will be considered for enrollment if they will be receiving 15 micorgrams of the H5N1 vaccine without an adjuvant or with 15 micrograms of the H5N1 vaccine with alum or MF59 adjuvant. Subjects will not be recruited outside the main vaccine trial.
  2. Subjects who understand and sign the consent form for this study.
  3. Subjects who meet pre-screening qualifications will be eligible for the initial pre-vaccination blood draw.

Exclusion Criteria:

1. All subjects who are ineligible for the main monovalent subvirion H5 vaccine trials will not be eligible for the CMI sub-study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337896

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00337896     History of Changes
Other Study ID Numbers: 06-0005
Study First Received: June 15, 2006
Last Updated: August 15, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
vaccine, influenza, A/H5N1, CMI, sub-study

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014