Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

NCT01381029 | Completed

• 1 other identifier: IRB080911
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human; Human Immunodeficiency Virus I Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HIV positive

HIV positive, receiving Influenza vaccine as standard of care.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Previous history of hypersensitivity reaction to influenza vaccine
• Unable to return for follow-up blood draw

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Marc Siegel, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: September 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)