T and B Cell Response to Avian Flu Vaccine

NCT ID: NCT00337896

Last Updated: 2013-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-05-31

Brief Summary

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.

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.

Conditions

Influenza

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

observation

healthy adults ages 18-64 years, enrolled at Stanford University Hospital and participating in another clinical trial (DMID Protocol 04-062)

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

06-0005

Identifier Type: -

Identifier Source: org_study_id