Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in antibody levels	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.	Pre-, 3 weeks post-, 3 months post- vaccine

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Marc Siegel, MD, George Washington University

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Orthomyxoviridae Infections; Slow Virus Diseases; HIV Infections; Influenza, Human; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: IRB080911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO