Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy

This is an interventional prevention trial for Herpes Zoster focused on measuring Herpes Zoster Vaccine, Herpes Zoster Virus, HIV Read More

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