Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals - Full Text View

Purpose

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.

Condition
Influenza, Human Human Immunodeficiency Virus I Infection


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A Study to Examine Immunological Response in HIV-Infected Patients Receiving the Seasonal Influenza Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Flu Flu Shot HIV/AIDS

U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:

Change in antibody levels [ Time Frame: Pre-, 3 weeks post-, 3 months post- vaccine ] [ Designated as safety issue: No ]
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.


Enrollment:	74
Study Start Date:	September 2009
Study Completion Date:	August 2014
Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
HIV positive HIV positive, receiving Influenza vaccine as standard of care.

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

HIV positive individuals receiving influenza vaccine as part of standard of care.

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381029

Locations


United States, District of Columbia
Medical Faculty Associates
Washington, District of Columbia, United States, 20037

Sponsors and Collaborators

George Washington University

Investigators


Principal Investigator:	Marc Siegel, MD	George Washington University

More Information


Responsible Party:	George Washington University
ClinicalTrials.gov Identifier:	NCT01381029 History of Changes
Other Study ID Numbers:	IRB080911
Study First Received:	June 23, 2011
Last Updated:	February 8, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No

Additional relevant MeSH terms:


Influenza, Human Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases	Immune System Diseases Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016