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.|
|ClinicalTrials.gov Identifier: NCT01381029|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : February 10, 2016
|Condition or disease|
|Influenza, Human Human Immunodeficiency Virus I Infection|
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
|Study Type :||Observational|
|Actual Enrollment :||74 participants|
|Official Title:||A Study to Examine Immunological Response in HIV-Infected Patients Receiving the Seasonal Influenza Vaccine|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
HIV positive, receiving Influenza vaccine as standard of care.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381029
|United States, District of Columbia|
|Medical Faculty Associates|
|Washington, District of Columbia, United States, 20037|
|Principal Investigator:||Marc Siegel, MD||George Washington University|