Clinical trial NCT01381029: Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals
Official title: A Study to Examine Immunological Response in HIV-Infected Patients Receiving the Seasonal Influenza Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Human Immunodeficiency Virus I Infection
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV positive individuals receiving influenza vaccine as part of standard of care.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in antibody levels
timeFrame: Pre-, 3 weeks post-, 3 months post- vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Marc Siegel, MD
role: PRINCIPAL_INVESTIGATOR
References: