Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Fluzone®; Fluzone®
Intervention description: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.; Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Flu vaccination; HIV infected individuals; Fluzone SD; Fluzone HD

Summary:

      The overall goal of this study is to compare the safety and immunogenicity of trivalent
      Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our
      hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used
      vaccine
    

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.

          7. Received a non-licensed agent (vaccine, drug, biologic, device, blood product, or
             medication) within 4 weeks prior to vaccination in this study with the exception of
             new antiretroviral medications as part of a phase 3 trial.

          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. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine,
             systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to
             study entry. NOTE: Subjects receiving stable physiologic glucocorticoid doses, defined
             as prednisone ≤10 mg/day, will not be excluded. Subjects receiving corticosteroids for
             acute therapy for an opportunistic infection such as Pneumocystis jiroveci pneumonia
             (PCP), or receiving a short course (defined as ≤2 weeks) of pharmacologic
             glucocorticoid therapy will not be excluded.

         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.