Shingles Prevention Study (SPS)

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007501
First received: December 29, 2000
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Postherpetic Neuralgia
Biological: Varicella-zoster vaccine
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CSP #403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Reduce burden of illness due to herpes zoster (HZ) [ Time Frame: Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash ] [ Designated as safety issue: No ]

Enrollment: 38456
Study Start Date: November 1998
Study Completion Date: February 2011
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
varicella-zoster vaccine
Biological: Varicella-zoster vaccine
Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.
Placebo Comparator: Arm 2
vaccine placebo
Biological: Placebo
Placebo vaccine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007501

  Hide Study Locations
Locations
United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Florida
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Kentucky
VA Medical Center, Lexington
Lexington, Kentucky, United States, 40502
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
NIH-NIAID (Bethesda, MD)
Bethesda, Maryland, United States, 20892
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
United States, New York
New York Harbor HCS
New York, New York, United States, 10010
VA Medical Center, Northport
Northport, New York, United States, 11768
Rochester, NY (NIH)
Rochester, New York, United States, 14642
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212-2637
United States, Texas
Baylor University
Houston, Texas, United States, 77030
University of Texas at San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Michael N. Oxman VA San Diego Healthcare System, San Diego
  More Information

Additional Information:
Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007501     History of Changes
Obsolete Identifiers: NCT00023257, NCT00001907, NCT00006065, NCT00006069
Other Study ID Numbers: 403
Study First Received: December 29, 2000
Last Updated: July 2, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
varicella-zoster vaccine

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia, Postherpetic
DNA Virus Infections
Herpesviridae Infections
Nervous System Diseases
Neuralgia
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014