Immune Response to Influenza Vaccine in HIV-Infected Individuals
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.
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).
INCLUSION CRITERIA:

 HIV Positive:

 1. Age greater than or equal 18 but less than or equal to 60 years old and willing and
 able to give informed consent

 2. Enrollment during the USA influenza season (October-March)

 3. 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:

 1. Age greater than or equal to 18 but less than or equal to 60 years old and willing and
 able to give informed consent

 2. Enrollment during USA influenza season (October-March)

 3. 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:

 1. Self-reported history of vaccination with the trivalent influenza preparation used for
 the current influenza season

 2. Self-reported vaccination with any vaccine within the one month period prior to study
 enrollment

 3. Acute febrile illness (may defer vaccine until resolved)

 4. History of hypersensitivity to any influenza vaccine components including thimerosal
 or egg

 5. History of Guillain-Barre syndrome

 6. Intention to receive any other vaccine during the study period

 7. Pregnancy

 8. Self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins,
 corticosteroids, or G(M)-CSF in the 4 weeks prior to enrollment

 9. Self-reported history of IL-2 administration within the past 5 years

 10. Use of theophylline preparations or warfarin because of the theoretical possibilities,
 of enhanced drug effects and toxicities post influenza vaccination

 11. Active infection or other serious illness other than HIV that might affect the immune
 response to a vaccine

 12. Current alcohol, substance abuse, or systemic/psychiatric illness that potentially
 could interfere with patient compliance and ability to make study visits

 HIV Negative:

 1. Self-reported history of vaccination with the trivalent influenza preparation used for
 the current influenza season

 2. Self-reported vaccination with any vaccine within the one month period prior to study
 enrollment

 3. Acute febrile illness (may defer vaccine until resolved)

 4. History of hypersensitivity to any influenza vaccine components including thimerosal
 or egg

 5. History of Guillain-Barre syndrome

 6. Intention to receive any other vaccine during the study period

 7. Pregnancy

 8. Self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins,
 corticosteroids, or G(M)-CSF in the 4 weeks prior to enrollment

 9. Use of theophylline preparations or warfarin because of the theoretical possibilities,
 of enhanced drug effects and toxicities post influenza vaccination

 10. Any medical conditions, or medication use might affect the immune response to a
 vaccine

 11. Current alcohol, substance abuse, or systemic/psychiatric illness that potentially
 could interfere with patient compliance and ability to make study visit