Status:

COMPLETED

T and B Cell Response to Avian Flu Vaccine

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Influenza

Eligibility:

All Genders

18-64 years

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 a...

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...

Eligibility Criteria

Inclusion

  • 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.
  • Subjects who understand and sign the consent form for this study.
  • Subjects who meet pre-screening qualifications will be eligible for the initial pre-vaccination blood draw.

Exclusion

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

Key Trial Info

Start Date :

March 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2006

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00337896

Start Date

March 1 2006

End Date

May 1 2006

Last Update

August 16 2013

Active Locations (1)

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Stanford University

Stanford, California, United States, 94305