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| 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 |
Phase III |
| MedlinePlus related topics: | Chickenpox Shingles |
| ChemIDplus related topics: | Zostavax |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | CSP#403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications |
| Estimated Enrollment: | 37200 |
| Study Start Date: | December 1997 |
| Estimated Study Completion Date: | April 2004 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Adults 60 years of age and older, History of Chickenpox, No history of shingles, no current history of immune suppression (e.g. malignancy or neoplastic disease, corticosteroid therapy)
The subject population will consist of male and female veterans and their spouses at VA sites and non-veterans and their spouses at non-VA sites who are 60 years of age or older, have given written informed consent prior to enrollment, and meet the following criteria:
History of varicella or long-term (greater than or equal to 30 years) residence in the continental USA.
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 |
Show 23 Study Locations |
More Information
Related Info
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| Study ID Numbers: | 403 |
| First Received: | December 29, 2000 |
| Last Updated: | February 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00007501 |
| Health Authority: | United States: Food and Drug Administration |
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