Influenza Vaccine in HIV Infection: Immune Response and Effect on Viral Load
HIV Infection
About this trial
This is an observational trial for HIV Infection focused on measuring Immunization, Titers, Immune Activation, Antibody, CD4 Cell Count, HIV
Eligibility Criteria
INCLUSION CRITERIA (HIV-Positive) 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 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 Self-reported pre-vaccine CD4 count greater than or equal to 400 cells/microliter. If day 0 CD4 cell count testing reveals a CD4 count less than 400, subject will be put off study and only receive compensation for initial visit. Self-reported use of HAART for a minimum of three months prior to enrollment. For this study, HAART is defined as at least 2 nucleoside reverse transcriptase inhibitor plus either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor 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 resovled) 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 (interluekins, corticosteroids, or G(M)-CSF) in the 4 weeks prior to enrollment. Epoetin use is permitted. Self-reported hidtory of IL-2 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, in the opinion of the investigator, 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 INCLUSION CRITERIA (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 of 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 -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 resovled) 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 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, that in the opinion of the investigator, 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
Sites / Locations
- National Institute of Allergy and Infectious Diseases (NIAID)