Protocol Number: 99-I-0106

Title:

Trial of Varicella Vaccine for the Prevention of Herpes zoster and Its Complications

Number:

99-I-0106

Summary:

Herpes zoster (HZ) is not a reportable disease, but the number of cases occurring annually in the United States is estimated to be between 200,000 and 500,000, with 35,000 to 100,000 occurring in Veterans. The incidence and severity of HZ, as well as the frequency and severity of its complications, increase markedly with increasing age. More than half of all cases occur in persons over the age of 60. Anecdotal data and the results of a small pilot study carried out during the planning phase of CSP#403, indicate that the quality of life and functional capacity of elderly persons are severely affected by HZ - to a degree that is at least comparable to such debilitating diseases as congestive heart failure, recent acute myocardial infarction, type II diabetes mellitus, and clinical depression. Even without complications, HZ can interfere with elderly patients' 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 post-therapeutic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression.

Because the frequency and severity of HZ and PHN increase markedly with increasing age, their impact on the quality of life of Veterans will grow as the Veteran population ages over the next two decades. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN.

Successful execution of this study will require detection and evaluation, beginning as soon as possible after onset, of essentially all cases of HZ that occur during post-vaccination follow-up. To accomplish this and maintain the interest and involvement of the study subjects, we plan active surveillance through the use of an innovative automated telephone response system (ATRS).

If the vaccine proves effective, it will provide a means to reduce morbidity and improve the quality of life of older individuals, and to reduce health care costs for the VA and the entire Nation. The proposed study will also yield important data, not presently available, on the current incidence and natural history of HZ and its complications, on the effect of HZ on the quality of life of older individuals and, perhaps, on specific defects in immunity to VZV with prognostic and therapeutic significance.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

This is a Department of Veterans Affairs (VA) cooperative study representing a scientific collaboration between the VA, the National Institute of Allergy and Infectious Diseases, and Merck & Co., Inc., the vaccine's producer. More information can be obtained by calling toll-free at 1-877-841-6251.

Keyword(s):

Controlled Trial

Geriatric Population

Post-Herpetic Neuralgia

Shingles

Recruitment Keyword(s):

Herpes zoster

Condition(s):

Herpes zoster

Vaccine

Investigational Drug(s):

Varicella Vaccine

Investigational Device(s):

None

Interventions:

Drug: Varicella Vaccine

Supporting Site:

National Institute of Allergy and Infectious Diseases@@@Merck & Co., Inc.

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Natural history of herpes zoster ophthalmicus: predictors of postherpetic neuralgia and ocular involvement

Population-based study of herpes zoster and its sequelae

Endonuclease analysis of viral DNA from varicella and subsequent zoster infections in the same patient

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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