Immune Response to Varicella-Zoster Vaccination and Infection

NCT00921999 | Completed

• 2 other identifiers: 09017009-I-0170
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chickenpox; Herpes Zoster

Keywords

Chickenpox; Shingles; Varicella; Zoster; Vaccine

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Group I Frequent Follow-up Group (N=110)
• years of age or older
• Patients about to receive the varicella vaccine, or were vaccinated within the last 5 days (if stored blood is available).
• Both males and females
• Subjects must be able to sign the consent form and be willing to comply with study procedures.
• Subjects must be willing to have their blood samples stored.
• Group II Infrequent Follow-up Group (N=30)
• years of age of older
• Patient about to receive the varicella vaccine, or were vaccinated within the last 30 days (if stored blood is available).
• Both males and females
• Subjects must be able to sign the consent form and be willing to comply with study procedures.
• Subjects must be willing to have their blood samples stored.
• Group III Vaccine Recipients-Vaccinated in the Past (N=60)
• years of age or older
• Patients were vaccinated with varicella vaccine at least 6 months previously and must provide written documentation of varicella vaccination

You may not qualify if:

• Study subjects will be excluded if they fulfill either of the following criteria:
• 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)
• History of chickenpox, zoster, or having received the zoster vaccine for patients in Groups I, II or III.
• Patients in group I found to have a hemoglobin \<11 gm/dl will be reassigned to group II or terminated from the study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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. doi: 10.1086/501900.

  PMID: 11428437 BACKGROUND

• 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. doi: 10.1016/s0264-410x(00)00297-8.

  PMID: 11115716 BACKGROUND

• 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. doi: 10.1002/jmv.1890320310.

  PMID: 2177782 BACKGROUND

• Cohen JI, Ali MA, Bayat A, Steinberg SP, Park H, Gershon AA, Burbelo PD. Detection of antibodies to varicella-zoster virus in recipients of the varicella vaccine by using a luciferase immunoprecipitation system assay. Clin Vaccine Immunol. 2014 Sep;21(9):1288-91. doi: 10.1128/CVI.00250-14. Epub 2014 Jul 2.

  PMID: 24990909 DERIVED

MeSH Terms

Conditions

Chickenpox; Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Jeffrey I Cohen, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: June 15, 2009
• Study Completion: January 8, 2015
• Last Updated: February 14, 2018

Record last verified: 2015-01-08

Locations

US (1)