Protocol Number: 99-I-0106

Title:

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

Number:

99-I-0106

Summary:

This study will evaluate the effectiveness of an experimental vaccine to prevent shingles (herpes zoster) and its complications, or to reduce the severity of disease if it occurs. Shingles is caused by the varicella-zoster virus, the same virus that causes chicken pox. The virus remains dormant in the body after recovery from chicken pox and may become active again years later, causing shingles instead of another episode of chicken pox. Shingles is a rash on an area of skin on one side of the body, perhaps on the head or face, shoulder, chest or back. The rash is often painful and accompanied by fluid-filled blisters. Shingles usually affects older people, who generally have lower levels of immunity to varicella-zoster virus. The vaccine is intended to boost immunity in this population.

Volunteers 60 years of age and older who are in reasonably good health and who have had chicken pox or have lived in the United States for at least 30 years may be eligible for this study.

Participants will be randomly assigned to receive either the varicella-zoster vaccine or a placebo. Both preparations will be given as an injection under the skin of the arm. Participants will be instructed about symptoms of shingles and possible reactions to the vaccine and will be required to report any unusual reactions to the research staff. In addition, they will be required to call a toll-free number once a month for up to 5 years to answer questions related to shingles. About 1 in 6 participants will also be asked to keep a daily written diary of complaints, rashes or unusual experiences for the first 6 weeks after the injection and to record their temperature for 21 days after the injection.

Participants who think they are developing shingles will report this to the study coordinator and be examined as soon as possible. A blood sample will be drawn to measure the immune response to the varicella-zoster virus. Rashes, if any, will be scraped and tested for the varicella-zoster virus or other viruses that cause rashes. Standard treatment with famciclovir will be offered. Patients will be questioned about their pain and discomfort and will be examined each day for 3 days after their rash appears, and then periodically at various intervals for 6 months. The area and appearance of the rash will be recorded, and photographs of the rash may be requested. Blood samples will be collected at 3 and 6 weeks after the appearance of the rash and again at brief visits 1, 2 and 3 years after the rash appears to measure immunity to the varicella-zoster virus.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects 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.

Disease Category:

PROTICD

Keywords:

Controlled Trial

Geriatric Population

Post-Herpetic Neuralgia

Shingles

Recruitment Keywords:

Herpes Zoster

Conditions:

Investigational Drug(s):

Varicella Vaccine

Investigational Device(s):

None

Contacts:

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.

Citations:

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.
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