Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Herpes Zoster, HIV Infections

In brief

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).

Key facts

Study ID

NCT00851786

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

395

Starts

2009-04-29

Expected to finish

2012-01-03

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• University of Southern California CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Denver Public Health CRS — Denver, Colorado, United States
• Georgetown University CRS (GU CRS) — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• The Ponce de Leon Center CRS — Atlanta, Georgia, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• IHV Baltimore Treatment CRS — Baltimore, Maryland, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Henry Ford Hosp. CRS — Detroit, Michigan, United States
• Washington U CRS — St Louis, Missouri, United States
• Cooper Univ. Hosp. CRS — Camden, New Jersey, United States
• New Jersey Medical School- Adult Clinical Research Ctr. CRS — Newark, New Jersey, United States
• Cornell CRS — New York, New York, United States

Full record on ClinicalTrials.gov

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