Young Adult Influenza Vaccine Immunogenicity Substudy

August 22, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

In Depth Immunologic Studies in Healthy Young Adults Who Receive The Standard Dose Fluzone® (15mcgHA/Virus Strain) Trivalent Inactivated Influenza Virus Vaccine

This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza antigens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goals of this study are to provide in depth humoral and cellular immune responses to the standard-dose trivalent SV influenza virus vaccine containing 15 pg HA of each virus strain in healthy young adults. Serum samples will be submitted for the following analysis: measurement of serum anti-HA (hemagglutinin) IgG and IgA antibodies by ELISA, IgG antibody subclasses, IgG and IgA Avidity, Virus neutralizing functional assay, HAI antibody titer. Peripheral blood mononuclear cells (PBMC) isolated from these subjects will be evaluated for the following: "central" (TCM) and "effector" (TEM) memory T cell responses, including their proliferative responses and cytokine production profiles by flow cytometry, IFN-7 production by ELISPOT, following specific antigenic stimulation. Serum samples will be submitted for the following analysis: measurement ex vivo of the frequency of circulating influenza-specificT cells by using commercially available MHC/tetramers and/or MHC/pentamers and flow cytometry, role of regulatory T cells in the modulation of influenza responses in young adults. Fifteen healthy young adult subjects, age 18-40 years, inclusive, will be recruited from the general population to be enrolled in this study. No randomization or masking procedures will be used. All eligible subjects will be administered one intramuscular (IM) injection of the same FDA approved standard-dose (15 mcg HA per strain) trivalent inactivated influenza vaccine, 2004-2005 season, and key humoral and cell-mediated immunity (CMI) responses will be compared to those of elderly subjects enrolled under DMID 05-0028. On both Day 0 (pre-vaccination) and day 28 (post-vaccination), an 100 ml volume of whole blood will be obtained for a complete blood count (CBC) with differential and to isolate and cryopreserve serum and PBMCs. This study will evaluate key humoral and cell-mediated immunity (CMI) responses in healthy young adults to establish a baseline immune response which will be used to evaluate changes associated with immunosenescence. This study is linked to DMID protocol 05-0028.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
  2. Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period (28 days).
  3. In good health, as determined by medical history and a targeted physical examination, if necessary.
  4. Able to understand and comply with planned study procedures.
  5. Able to provide informed consent and be available for all study visits.

Exclusion Criteria:

  1. Has a known allergy to eggs or other components of the vaccine.
  2. Has a positive urine pregnancy test at screening or prior to vaccination (if female), is lactating, or has the intention to become pregnant within 3 months of enrollment in this study.
  3. Is undergoing immunosuppression as a result of an underlying illness or treatment.
  4. Has an active neoplastic disease or a history of any hematologic malignancy.
  5. Is using oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
  6. Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
  7. Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  8. Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
  9. Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
  10. Has an acute illness, including an oral temperature greater than 100.4 degrees F, within one week of vaccination.
  11. Received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expects to receive an experimental vaccine, medication, or blood product during the 4 week study period.
  12. Has any condition that would place the volunteer at an unacceptable risk of injury or any condition that in the opinion of the investigator may compromise the safety of the volunteer or integrity of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

August 23, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-0055
  • Influenza CVD 12000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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