Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine

Completed · Not applicable

Conditions studied: Influenza

In brief

This study may determine whether laboratory studies of people's blood cells, who have received vaccines against H5 influenza, or "bird flu," will help to decide if the vaccines are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled in the studies "A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults" and "in Healthy Elderly Adults" will participate. Participants may be involved in this study for about 14 months. Procedures may include blood draws, physical exams, and medical history reviews.

Key facts

Study ID

NCT00311727

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

339

Starts

2005-10-01

Expected to finish

2006-03-01

Last updated by the study team

2013-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects who are eligible and enrolled in the main monovalent subvirion H5 vaccine trials [Division of Microbiology and Infectious Diseases (DMID) studies 04-063 and 04-076] and have agreed to the extra blood draws for the cell-mediated immunity (CMI) sub-study will be enrolled.
• Subjects will not be recruited outside the main vaccine trials or future DMID sponsored influenza A/H5N1 studies.
• Subjects who understand and sign the consent form for this study.
• Subjects who meet pre-screening qualifications for the DMID study will be eligible for the initial pre-vaccination blood draw.
• Subjects who meet all inclusion criteria for the DMID study and who are vaccinated will be allowed to participate in the remaining portions of this study.

You may not qualify if…

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

Where it is running

• University of Maryland Baltimore — Baltimore, Maryland, United States
• University of Rochester — Rochester, New York, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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