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Shingles Prevention Study (SPS)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Department of Veterans Affairs
Merck
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007501
  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 III

MedlinePlus related topics: Chickenpox Shingles
Drug Information available for: Zostavax
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: CSP#403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications

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: December 1997
Estimated Study Completion Date: December 2010
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
varicella-zoster vaccine
Biological: Varicella-zoster vaccine
Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.
2: Placebo Comparator
vaccine placebo
Biological: Placebo
Placebo vaccine.

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

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Sponsors and Collaborators
Merck
Investigators
Study Chair: Michael N. Oxman VA San Diego Healthcare System, San Diego
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Department of Veterans Affairs ( Oxman, Michael - Study Chair )
Study ID Numbers: 403
Study First Received: December 29, 2000
Last Updated: August 7, 2008
ClinicalTrials.gov Identifier: NCT00007501  
Health Authority: United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
varicella-zoster vaccine,Herpes Zoster,Postherpeti

Study placed in the following topic categories:
Herpes Zoster
Neuralgia, Postherpetic
Neuralgia
Chickenpox
Pain
Varicella Zoster
Herpesviridae Infections
Virus Diseases
Signs and Symptoms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Neurologic Manifestations
DNA Virus Infections
Chicken pox

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009