Immune Response to Influenza Vaccine in HIV-Infected Individuals

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