H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients

Exclusion Criteria

• •1. Has a known allergy to eggs or other components in the vaccines (these may include, but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein).
• •2. Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV.
• •3. Participation in a novel H1N1 influenza vaccine study in the past two years.
• •4. Proven history, by RT-PCR, of novel influenza H1N1 infection, or, has a positive influenza diagnostic testing since June 2009 (specificity to H1N1 not required) prior to study entry.
• •5. Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 1 week prior to study entry.
• •6. Scheduled administration of any live virus vaccine or inactivated vaccine at or between entry and the Day 21 visit. NOTE: Live or inactivated vaccines expected to be administered between study entry and the Day 21 visit should be excluded to prevent potential interference with immunogenicity responses and confounding safety results. Regular seasonal flu vaccination will be allowed if is separated more than 7 days from the administration of the H1N1 vaccine.
• •7. Received a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study
• •8. An acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry.
• •9. Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment, or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection).
• •10. Active neoplastic disease (excluding non-melanoma skin cancer, and HPV-related cervical dysplasia, CIN grades 1, 2 or 3).
• •11. Long term use of glucocorticoids, including oral or parenteral prednisone or equivalent (more than 2.0 mg/kg per day or more than 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the past 3 months (nasal and topical steroids are allowed).
• •12. Received immunoglobulin or other blood products
• •13. Current diagnosis of uncontrolled major psychiatric disorder.
• •14. History of Guillain-Barré Syndrome in the subject or subject's family (parents, siblings, half siblings, or children).
• •15. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.