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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 Biological: Placebo |
Phase III |
| 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.
|
Show Detailed Description
Eligibility
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 22 Study Locations| Study Chair: | Michael N. Oxman | VA San Diego Healthcare System, San Diego |
More Information