Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy
Condition: Herpes Zoster; HIV Infections
MeSH terms: Herpes Zoster
Intervention: ZOSTAVAX; Placebo
Intervention description: Subcutaneous injection of 0.65 mL of ZOSTAVAX at Day 0 and Week 6; Subcutaneous injection of 0.65 mL of placebo at Day 0 and Week 6
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Herpes Zoster Vaccine; Herpes Zoster Virus; HIV

Summary:

      Herpes zoster, or shingles, is the result of a viral infection that causes a painful skin
      rash, usually in older people or people with suppressed immune systems like those infected
      with HIV. The ZOSTAVAX vaccine has been shown to reduce the number of infections and symptoms
      of herpes zoster infection in people over the age of 60. The purpose of this study is to
      evaluate the safety, tolerability, and immunogenicity of two doses of ZOSTAVAX in
      HIV-1-infected adults with conserved immune function (Cd4+ T cell counts >=200 cells/uL)
      virologically suppressed on potent combination antiretroviral therapy (ART).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected

          -  Use of potent combination ART regimen within 90 days prior to entry and undetectable
             plasma HIV RNA level within 90-210 days prior to study entry

          -  CD4 cell count of at least 200 cells/uL obtained within 30 days prior to study entry

          -  Laboratory values obtained within 90 days prior to study entry

               -  Hemoglobin 7.0 g/dL or greater

               -  Platelet count 50,000/mm3 or greater

               -  Creatinine 3 x ULN or less

               -  AST (SGOT), ALT (SGPT), and alkaline phosphatase 5 x ULN or less

          -  For females of reproductive potential, a negative serum or urine pregnancy test within
             24 hours prior to study entry

          -  Willing to use accepted forms of contraception for the duration of the study

          -  History of varicella or herpes zoster more than 1 year prior to vaccination or VZV
             seropositivity at any time prior to entry

          -  Men and women age >=18 years

          -  Ability and willingness of subject or legal guardian/representative to provide
             informed consent

        Exclusion Criteria:

          -  History of nadir CD4+ count <100 cells/uL

          -  Known or suspected immune dysfunction caused by a medical condition or any cause other
             than HIV infection, such as congenital immunodeficiency, organ or bone marrow
             transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or
             generalized malignancy [NOTE: Subjects with prostate or breast cancer who are not on
             chemotherapeutic drugs (other than hormone blocking drugs), subjects with skin cancer
             or Kaposi's sarcoma limited to skin who are not receiving radiation therapy or
             chemotherapy, and subjects with a history of other malignancies who have been
             disease-free for at least 5 years will be eligible for enrollment.]

          -  Receipt of any varicella or zoster vaccine prior to study entry

          -  History of allergy/sensitivity, or hypersensitivity to any vaccine component,
             including gelatin or neomycin

          -  Receipt of immunoglobulin or any blood products, other than autologous blood
             transfusion, given during the 5 months prior to study entry or expected during the
             24-week study period

          -  Receipt of any live virus vaccine within 28 days prior to study entry or during study
             period

          -  Receipt of any inactivated vaccine within 7 days prior to study entry or during study
             period

          -  Scheduled administration of any live virus vaccine or inactivated vaccine at or
             between study entry and the Week 12 visit

          -  Participation in an investigational drug study within the last 30 days prior to study
             entry

          -  Use of immunosuppressive therapy. More information can be found in the protocol.

          -  Any chronic suppressive antiviral therapy with activity against herpes viruses,
             including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir,
             foscarnet, and cidofovir within 7 days prior to study entry or expected use through
             the 24-week study period except where necessary for acute treatment of intercurrent
             viral infection.

          -  Any episode of VZV reactivation in the 12 months prior to study entry

          -  Active drug or alcohol use, dependence, or any other reason that, in the opinion of
             the site investigator, would interfere with the study

          -  Pregnancy (including subjects who are expecting to conceive within 3 months of the
             second vaccination) or breast feeding

          -  Any acute intercurrent illness that might interfere with the interpretation of the
             study

          -  Significant underlying illness preventing completion of the study