Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01381029
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : February 10, 2016
Information provided by (Responsible Party):
George Washington University

June 23, 2011
June 27, 2011
February 10, 2016
September 2009
August 2014   (Final data collection date for primary outcome measure)
Change in antibody levels [ Time Frame: Pre-, 3 weeks post-, 3 months post- vaccine ]
The primary endpoint will be to measure the change from baseline in vaccine-strain specific antibody levels. Titers of > or = 40 U will be considered protective and a > 4-fold rise in antibody titer will be considered an adequate response in previously antibody-negative patients. Data from this study will assist in defining the efficacy of the influenza vaccine in the HIV-infected population and the ability of HIV-infected patients to generate an appropriate immune response, as well as maintain an appropriate response, to the influenza vaccine.
Same as current
Complete list of historical versions of study NCT01381029 on Archive Site
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Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals
A Study to Examine Immunological Response in HIV-Infected Patients Receiving the Seasonal Influenza Vaccine
Investigators in the Division of Infectious Diseases are carrying out a study to determine if human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza vaccination develop an adequate antibody response. The study group will consist of individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the Seasonal Influenza vaccine.

This is a study to establish the immunologic response in HIV-seropositive individuals to the FDA approved seasonal influenza vaccine when it is available. HIV-seropositive individuals seen in the Infectious Diseases Clinic at George Washington University, Medical Faculty Associates and receive this vaccination, on label, as part of standard of care will be invited to participate.

The study will require a 10-ml sample of whole blood to be drawn from each participant prior to the dose of the seasonal influenza vaccine and at 3 weeks after the vaccine dose and at 3 months after the vaccine dose. No additional samples are envisioned. Serum will be separated and will frozen and stored in the Clinical Trials Unit until all patient samples have been obtained. At that time the antibody levels to the vaccine antigens will be measured.

Data that will be collected from the subject's medical record includes the following:

  • Age, gender, race
  • CD4 count
  • HIV viral load
  • History of prior influenza immunization including the 2009-2010 trivalent vaccine
  • HIV antiviral medication history

Data that will be collected from the subject during participation in study

  • Antibody levels prior to vaccination
  • Dose date of the seasonal influenza vaccination
  • Antibody levels 3 weeks after the vaccination
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
HIV positive individuals receiving influenza vaccine as part of standard of care.
  • Influenza, Human
  • Human Immunodeficiency Virus I Infection
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HIV positive
HIV positive, receiving Influenza vaccine as standard of care.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or female patients ages 18 or older
  • Diagnosis of HIV infection
  • No contraindications to being able to receive influenza vaccine by the treating physician
  • No acute active illness
  • Able to provide informed consent

Exclusion Criteria:

  • Previous history of hypersensitivity reaction to influenza vaccine
  • Unable to return for follow-up blood draw
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Plan to Share IPD: No
George Washington University
George Washington University
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Principal Investigator: Marc Siegel, MD George Washington University
George Washington University
January 2016