T and B Cell Response to Avian Flu Vaccine

Completed

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00337896

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30

Starts

2006-03-01

Expected to finish

2006-05-01

Last updated by the study team

2013-08-16

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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