H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: H1N1 vaccination
Intervention description: Novartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; H1N1 vaccination; HIV infected individuals

Summary:

      The overall goal of this study is to study influenza vaccine responses in HIV infected
      individuals. Immunocompromised individuals require special protection from influenza, but may
      not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu
      vaccine as part of their standard of care will be asked to donate blood samples for
      immunologic studies. These studies will determine whether participants were able to produce
      the appropriate antibodies to the vaccine and possibly identify predictors of vaccine
      responsiveness.

      Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be
      compromised in HIV infected patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A confirmed diagnosis of HIV-1 infection as documented by any licensed ELISA test kit
             and confirmed by Western blot at any time prior to study entry or any measurable HIV
             RNA viral load in the chart. Serum HIV-1 antigen, plasma HIV-1 RNA, or a second
             antibody test by a method other than ELISA is acceptable as an alternative
             confirmatory test.

          2. > 18 years

          3. Able to understand and comply with planned study procedures.

          4. Provides written informed consent prior to initiation of any study procedures.

          5. Subject should be 1) on stable antiretroviral therapy as outlined in the DHHS
             treatment guidelines for HIV-1 infected individuals OR 2) not on antiretroviral
             therapy and not intending to start treatment within the next 30 days.

        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.