Protocol Number: 09-I-0170

Title:

Immune Responses to Varicella-Zoster Virus Vaccination and Infection

Number:

09-I-0170

Summary:

Background:

- The common varicella-zoster virus causes both chickenpox and shingles. Both diseases cause rashes, but they can also have complications such as bacterial infections of the skin, pneumonia, or eye disease.

- By drawing and studying blood samples from people who have been infected with the varicella-zoster virus or who are receiving or have received the varicella vaccine, researchers hope to learn more about the immune system's response to the virus.

Objectives:

- To determine the immune system's response to the varicella virus, either in its existing form or given as part of a vaccine.

Eligibility:

- Individuals 18 years of age and older who have had or are receiving the varicella vaccine.

- Individuals 5 years of age and older who currently have chickenpox or shingles.

Design:

- Participants will visit the NIH Clinical Center for an initial physical examination, and will provide blood samples for evaluation.

- Researchers will determine the number of samples to be taken and the amount of blood to be drawn as needed based on the participants' medical history and exposure to the varicella-zoster virus.

Investigators in this study will not be giving subjects either the chickenpox or shingles vaccine. They will only be looking at the response to the vaccine in persons who are receiving or have received the vaccine from their health care provider.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Group I Frequent Follow-up Group (N=110)

1. 18 years of age or older

2. Patients about to receive the varicella vaccine, or were vaccinated within the last 5 days (if blood was stored by OMS).

3. Both males and females

4. Subjects must be able to sign the consent form and be willing to comply with study procedures.

5. Subjects must be willing to have their blood samples stored.

Group II Infrequent Follow-up Group (N=30)

1. 18 years of age of older

2. Patient about to receive the varicella vaccine, or were vaccinated within the last 30 days (if blood was stored by OMS).

3. Both males and females

4. Subjects must be able to sign the consent form and be willing to comply with study procedures.

5. Subjects must be willing to have their blood samples stored.

Group III Vaccine Recipients-Vaccinated in the Past (N=60)

1. 18 years of age or older

2. Patients were vaccinated with varicella vaccine at least 6 months previously and must provide written documentation of varicella vaccination

3. Both males and females

4. Subjects must be able to sign the consent form and be willing to comply with study procedures.

5. Subjects must be willing to have their blood samples stored.

Group IV Patients with Varicella or Zoster (N=110)

1. 5 years or older

2. Patients presenting with varicella or zoster.

3. Both males and females

4. Subjects and/or parents/guardians must be able to sign the consent or assent form and be willing to comply with study procedures.

5. Subjects must be willing to have their blood samples stored.

EXCLUSION CRITERIA:

Study subjects will be excluded if they fulfill either of the following criteria:

1. Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety (Groups I, II, IV who will be providing several blood samples)

2. History of chickenpox, zoster, or having received the zoster vaccine for patients in Groups I, II or III.

3. Patients in group I found to have a hemoglobin < 11 gm/dl will be reassigned to group II or terminated from the study.

Special Instructions:

Currently Not Provided

Keywords:

Chickenpox

Shingles

Varicella

Zoster

Vaccine

Recruitment Keyword(s):

Chickenpox

Shingles

Varicella

Vaccine

Condition(s):

Chickenpox

Herpes Zoster

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Saiman L, LaRussa P, Steinberg SP, Zhou J, Baron K, Whittier S, Della-Latta P,Gershon AA. Persistence of immunity to varicella-zoster virus after vaccination of healthcare workers. Infect Control Hosp Epidemiol. 2001 May;22(5):279-83.

Sharrar RG, LaRussa P, Galea SA, Steinberg SP, Sweet AR, Keatley RM, Wells ME,Stephenson WP, Gershon AA. The postmarketing safety profile of varicella vaccine. Vaccine. 2000 Nov 22;19(7-8):916-23.

Wasmuth EH, Miller WJ. Sensitive enzyme-linked immunosorbent assay for antibody to varicella-zoster virus using purified VZV glycoprotein antigen. J Med Virol. 1990 Nov;32(3):189-93.

• 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 of Clinical Research Informatics, CC.

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