Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Influenza, Human; Human Immunodeficiency Virus I Infection

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

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	74 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
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

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
HIV positive; HIV positive, receiving Influenza vaccine as standard of care.

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	George Washington University
ClinicalTrials.gov Identifier:	NCT01381029 History of Changes
Other Study ID Numbers:	IRB080911
First Posted:	June 27, 2011
Last Update Posted:	February 10, 2016
Last Verified:	January 2016
Individual Participant Data (IPD) Sharing Statement:
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