Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

NCT ID: NCT01381029

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-08-31

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

Conditions

Influenza, Human; Human Immunodeficiency Virus I Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV positive

HIV positive, receiving Influenza vaccine as standard of care.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Siegel, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

Medical Faculty Associates

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

IRB080911

Identifier Type: -

Identifier Source: org_study_id