Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Influenza A/H5N1

Detailed Description

This study is linked to DMID protocol 04-063 and 04-076, "A Randomized, Double Blinded, Placebo-ontrolled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults (04-063)" and also "in Healthy Elderly Adults" (04-076). All adult subjects enrolled in the main vaccine trials at Vanderbilt (04-076), Maryland (04-063), and Rochester (04-063) will be eligible for enrollment in the cell-mediated immune response sub-study. A maximum of 232 healthy ambulatory male and female subjects; 180 subjects 18 to 64 years old and 64 subjects aged 65 years and older, in the United States, could be enrolled. The primary objectives are: to establish a reproducible, functional cell-mediated immune response assay to evaluate the magnitude and functional capacity of T cells responding to monovalent subvirion H5 influenza vaccine and to evaluate the percent of subjects demonstrating a CD4+ and/or CD8+ response approximately 14 days after the first vaccination and 14 days and 6 months after the second vaccination (04-063), and 14 days after the first and second vaccination and 14 days and 6 months after the third vaccination (04-076). The secondary objectives are: to evaluate dose-related and age-related humoral immunogenicity compared to the cellular immune responses approximately 14 days after the first vaccination and 14 days and 6 months after the second vaccination (04-063), and 14 days after the first and second vaccination and 14 days and 6 months after the third vaccination (04-076) and to establish CMI assays that can be applied to future avian vaccine immunogenicity evaluation, such as the Chiron H9N2 avian influenza vaccine, future H7 vaccines, or vaccines with other avian HA molecules. The study outcome measure, immunogenicity will be based on H5 strain-specific cell-mediated immunity measured 14 days after the first, second, and third (04-076 only) dose, and month 6 after the last dose of vaccine.

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Baltimore
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2581
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Subjects will not be recruited outside the main vaccine trials or future DMID sponsored influenza A/H5N1 studies.
3. Subjects who understand and sign the consent form for this study.
4. Subjects who meet pre-screening qualifications for the DMID study will be eligible for the initial pre-vaccination blood draw.
5. 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.

Exclusion Criteria:

1. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Influenza A/H5N1; 232 subjects receiving Influenza A/H5N1 vaccine.	Biological: Influenza A/H5N1; 232 subjects receive Influenza A/H5N1 vaccine as part of DMID protocols 04-063 and 04-076.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: April 5, 2006
• First Submitted That Met QC Criteria: April 5, 2006
• First Posted (Estimate): April 6, 2006

Study Record Updates

• Last Update Posted (Estimate): August 16, 2013
• Last Update Submitted That Met QC Criteria: August 15, 2013
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: Cell-Mediated Immune Responses, Influenza, A/H5N1, Vaccine, sub-study
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Influenza in Birds
• Other Study ID Numbers: 05-0006