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Immune Response to Varicella-Zoster Vaccination and Infection
This study is currently recruiting participants.
Verified January 2012 by National Institutes of Health Clinical Center (CC)

First Received on June 16, 2009.   Last Updated on May 23, 2012   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00921999
  Purpose

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.

...


Condition
Chickenpox
Herpes Zoster

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Immune Responses to Varicella-Zoster Virus Vaccination and Infection

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Shingles
U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 310
Study Start Date: June 2009
Detailed Description:

Varicella-zoster virus (VZV) causes chickenpox (varicella) and shingles (zoster). Antibody is important for control of varicella as evidenced by the role of varicella immune globulin in limiting the severity of disease in immunocompromised persons. Limited information is available regarding the individual viral proteins to which antibodies are produced during primary infection with VZV or after vaccination. Furthermore, commercially available tests to determine seropositivity to VZV after vaccination have limited sensitivity, and improved assays are needed. We will obtain blood from persons with varicella, zoster, and those vaccinated with the varicella (not zoster) vaccine at the NIH Clinical Center and measure immune responses against specific viral proteins, look for virus in the blood, and in some cases measure immune responses against cellular proteins over time. Elucidation of these responses might help to develop more sensitive assays for VZV seropositivity after vaccination and determine how the varicella vaccine protects against varicella.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 stored blood is available).
  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 stored blood is available).
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921999

Contacts
Contact: Rachael D Fulton (301) 594-3094 mabyour@mail.nih.gov
Contact: Jeffrey I Cohen, M.D. jcohen@niaid.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)     800-411-1222 ext TTY8664111010     prpl@mail.cc.nih.gov    
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Jeffrey I Cohen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
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.

ClinicalTrials.gov Identifier: NCT00921999     History of Changes
Other Study ID Numbers: 090170, 09-I-0170
Study First Received: June 16, 2009
Last Updated: May 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Chickenpox
Shingles
Varicella
Zoster
Vaccine

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 24, 2012



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