Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine

NCT00311727 | Completed

• 1 other identifier: 05-0006
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Influenza

Keywords

Cell-Mediated Immune Responses, Influenza, A/H5N1, Vaccine, sub-study

Study Arms (1)

Influenza A/H5N1

EXPERIMENTAL

232 subjects receiving Influenza A/H5N1 vaccine.

Biological: Influenza A/H5N1

Interventions

Influenza A/H5N1 BIOLOGICAL

232 subjects receive Influenza A/H5N1 vaccine as part of DMID protocols 04-063 and 04-076.

Influenza A/H5N1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-2581, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Study Start: October 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: August 16, 2013

Record last verified: 2007-05

Locations

US (3)