Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

George Washington University

ClinicalTrials.gov Identifier:

NCT01381029

First received: June 23, 2011

Last updated: August 28, 2012

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2011

Last Updated Date

August 28, 2012

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01381029 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

Official Title ^ICMJE

A Study to Examine Immunological Response in HIV-Infected Patients Receiving the Seasonal Influenza Vaccine

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Influenza, Human
Human Immunodeficiency Virus I Infection

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

HIV positive

HIV positive, receiving Influenza vaccine as standard of care.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

July 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01381029

Other Study ID Numbers ^ICMJE

IRB080911

Has Data Monitoring Committee

Responsible Party

George Washington University

Study Sponsor ^ICMJE

George Washington University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marc Siegel, MD

George Washington University

Information Provided By

George Washington University

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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