Status:
COMPLETED
Immune Response to Varicella-Zoster Vaccination and Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chickenpox
Herpes Zoster
Eligibility:
All Genders
5+ years
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, pneumon...
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 s...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Group I Frequent Follow-up Group (N=110)
- 18 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)
- 18 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)
- 18 years of age or older
- Patients were vaccinated with varicella vaccine at least 6 months previously and must provide written documentation of varicella vaccination
- 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 IV Patients with Varicella or Zoster (N=110)
- 5 years or older\<TAB\>
- Patients presenting with varicella or zoster.
- Both males and females
- Subjects and/or parents/guardians must be able to sign the consent or assent form and be willing to comply with study procedures.
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
June 15 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 8 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00921999
Start Date
June 15 2009
End Date
January 8 2015
Last Update
February 14 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892