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Trial record 19 of 457 for:    Shingles

Shingles Prevention Study (SPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00007501
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : July 4, 2013
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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 or disease Intervention/treatment Phase
Herpes Zoster Postherpetic Neuralgia Biological: Varicella-zoster vaccine Biological: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CSP #403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications
Study Start Date : November 1998
Actual Primary Completion Date : April 2004
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007501


  Show 22 Study Locations
Sponsors and Collaborators
VA Office of Research and Development
Merck Sharp & Dohme Corp.
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Michael N. Oxman VA San Diego Healthcare System, San Diego

Additional Information:
Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00007501     History of Changes
Obsolete Identifiers: NCT00001907, NCT00006065, NCT00006069, NCT00023257
Other Study ID Numbers: 403
First Posted: January 1, 2001    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: July 2013

Keywords provided by VA Office of Research and Development:
varicella-zoster vaccine

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs