Shingles Prevention Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Herpes Zoster, Postherpetic Neuralgia

In brief

The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patient's ability to perform essential activities of daily living, resulting in a loss of independence that is emotionally devastating and frequently irreversible. The most common complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN. This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of age and older.

Key facts

Study ID

NCT00007501

Run by

US Department of Veterans Affairs

People needed

38456

Starts

1998-11-01

Expected to finish

2011-02-01

Last updated by the study team

2013-07-04

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults 60 years of age and older.
• History of Chickenpox.
• Have given written informed consent prior to enrollment.
• History of varicella or long-term (greater than or equal to 30 years) residence in the continental USA.

You may not qualify if…

• No history of shingles, no current history of immune suppression (e.g. malignancy or neoplastic disease, corticosteroid therapy).
• No immunosuppression resulting from disease (e.g., malignancy; HIV infection), corticosteroids (except intermittent topical or inhaled corticosteroid [greater than 800 mcg/day beclomethasone dipropionate or equivalent]), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation).
• No active neoplastic disease (except local skin cancer or other malignancies [e.g., prostate cancer] that are stable in the absence of immunosuppressive/cytotoxic therapy).
• No prior Herpes Zoster.
• No prior receipt of varicella vaccine.
• No allergic sensitivity to neomycin.
• No history of anaphylactoid reaction to gelatin.
• No significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 5 years).
• Not ambulatory (must not be bed-ridden or homebound).
• No receipt of immune globulin or any other blood product within 3 months before or planned during the 3-5 year study period.
• No receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products [e.g., dT, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 6 weeks after study vaccination.
• Not currently receiving antiviral therapy.
• No other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study.
• No intercurrent illness (e.g., urinary tract infection, influenza) that might interfere with the interpretation of the study.
• No females who are pre-menopausal.
• No subjects unlikely to adhere to protocol follow-up.
• No subjects involved in a conflicting (vaccine or investigational drug) clinical trial.

Where it is running

• VA Medical Center, Birmingham — Birmingham, Alabama, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• VA San Diego Healthcare System, San Diego — San Diego, California, United States
• University of Colorado — Denver, Colorado, United States
• James A. Haley Veterans Hospital, Tampa — Tampa, Florida, United States
• Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
• VA Medical Center, Lexington — Lexington, Kentucky, United States
• VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States
• NIH-NIAID (Bethesda, MD) — Bethesda, Maryland, United States
• VA Medical Center, Jamaica Plain Campus — Boston, Massachusetts, United States
• VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
• VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
• VA Medical Center, St Louis — St Louis, Missouri, United States
• New Mexico VA Health Care System, Albuquerque — Albuquerque, New Mexico, United States
• New York Harbor HCS — New York, New York, United States
• VA Medical Center, Northport — Northport, New York, United States
• Rochester, NY (NIH) — Rochester, New York, United States
• VA Medical Center, Durham — Durham, North Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Baylor University — Houston, Texas, United States
• University of Texas at San Antonio — San Antonio, Texas, United States
• VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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