Shingles Prevention Study (SPS)
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|ClinicalTrials.gov Identifier: NCT00007501|
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : July 4, 2013
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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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38456 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Arm 1
Biological: Varicella-zoster vaccine
Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.
Placebo Comparator: Arm 2
- 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|
- 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.
- 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.
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
|Study Chair:||Michael N. Oxman||VA San Diego Healthcare System, San Diego|
Publications of Results:
|Responsible Party:||US Department of Veterans Affairs|
|Obsolete Identifiers:||NCT00001907, NCT00006065, NCT00006069, NCT00023257|
|Other Study ID Numbers:||
|First Posted:||January 1, 2001 Key Record Dates|
|Last Update Posted:||July 4, 2013|
|Last Verified:||July 2013|
DNA Virus Infections
Peripheral Nervous System Diseases
Nervous System Diseases
Varicella Zoster Virus Infection