Immune Response to Influenza Vaccine in HIV-Infected Individuals

This study will evaluate how HIV infection, including CD4 cell count and viral load, affects the patient's ability to produce antibodies in response to vaccination with the influenza (flu) vaccine. Earlier studies have shown that people with HIV infection do not respond as well as healthy subjects to flu vaccine; that is, they don't make as many antibodies in response to the vaccine. Before the use of current anti-HIV medications, antibodies made to flu vaccination in HIV-positive individuals was related to their CD4 cell count. This trial will examine how CD4 counts and the amount of virus in the blood affect how much and what kind of antibodies the body makes to the flu vaccine.

HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Healthy subjects will serve as controls to make sure the flu vaccine works (i.e., stimulates production of enough antibody to protect against the flu), and to compare the amount of antibodies made by HIV-positive and HIV-negative people. Candidates will be screened with a medical history and blood tests (see below). Women who are able to have children will have a pregnancy test. Pregnant women are excluded from the study.

Participants will undergo the following procedures:

1. Blood drawing for the following tests:

* Routine tests (complete blood count, kidney and liver functions, electrolyte levels). * CD4 cell count. * HLA typing (a genetic marker of the immune system) if it has not already been done at the NIH. This test may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions. Determining HLA type is necessary to be able to perform certain research studies. Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems. * Viral load (HIV-infected patients only). * Influenza antibody levels. * B cell levels. 2. Flu vaccination 3. Follow-up visits on days, 7, 28, and 54 after vaccination for the following:

* Review of any illnesses or fever. * Review of medications, if any changes were made. * Repeat blood tests.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Influenza, Human Lentivirus Infections Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

About this study

The purpose of this protocol is to evaluate the effect of HIV viral load and CD4 counts on the generation of influenza-specific antibodies and influenza-specific B cell responses in HIV-infected adults. HIV-infected subjects will be enrolled to receive the influenza vaccine appropriate to the on-going USA influenza season (Oct-March). Laboratory studies (including influenza titers, influenza-specific B cell frequencies, CD4 counts, and HIV viral loads) will be obtained at baseline (day of vaccination), day 7, 28, and 54 post-vaccination. HIV-negative healthy volunteers will serve as controls. Although there are some risks to influenza vaccine, the CDC Advisory Committee on Immunizations recommends influenza vaccination for HIV-infected patients. The primary study risks are those of phlebotomy and the inconvenience of multiple visits. Subjects will be compensated for participation in the study. Total enrollment of the study is a maximum of 165 subjects (132 HIV-infected individuals and 33 HIV-negative controls).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HIV Positive:

Age greater than or equal 18 but less than or equal to 60 years old and willing and able to give informed consent
Enrollment during the USA influenza season (October-March)
Self-reported history of HIV infection at enrollment (If NIH HIV testing does not confirm that the subject is HIV-positive, the subject will be discontinued from the study and not included in the analysis.)

HIV Negative:

Age greater than or equal to 18 but less than or equal to 60 years old and willing and able to give informed consent
Enrollment during USA influenza season (October-March)
Self-reported healthy HIV-negative (If NIH HIV testing does not confirm that the subject is HIV-negative, the subject will be discontinued from the study and not included in the analysis.)

Exclusion criteria

HIV Positive:

Self-reported history of vaccination with the trivalent influenza preparation used for the current influenza season
Self-reported vaccination with any vaccine within the one month period prior to study enrollment
Acute febrile illness (may defer vaccine until resolved)
History of hypersensitivity to any influenza vaccine components including thimerosal or egg
History of Guillain-Barre syndrome
Intention to receive any other vaccine during the study period
Pregnancy
Self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins, corticosteroids, or G(M)-CSF in the 4 weeks prior to enrollment
Self-reported history of IL-2 administration within the past 5 years
Use of theophylline preparations or warfarin because of the theoretical possibilities, of enhanced drug effects and toxicities post influenza vaccination
Active infection or other serious illness other than HIV that might affect the immune response to a vaccine
Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with patient compliance and ability to make study visits

HIV Negative:

Self-reported history of vaccination with the trivalent influenza preparation used for the current influenza season
Self-reported vaccination with any vaccine within the one month period prior to study enrollment
Acute febrile illness (may defer vaccine until resolved)
History of hypersensitivity to any influenza vaccine components including thimerosal or egg
History of Guillain-Barre syndrome
Intention to receive any other vaccine during the study period
Pregnancy
Self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins, corticosteroids, or G(M)-CSF in the 4 weeks prior to enrollment
Use of theophylline preparations or warfarin because of the theoretical possibilities, of enhanced drug effects and toxicities post influenza vaccination
Any medical conditions, or medication use might affect the immune response to a vaccine
Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with patient compliance and ability to make study visit

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

Immune Response to Influenza Vaccination in HIV-Infected Individuals

Important dates

Study start: 2003
Study completion: 2005
First posted: Oct 3, 2003
Registry last updated: Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed