Immune Responses to Varicella-Zoster Virus Vaccination and Infection
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| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Chickenpox - Herpes Zoster |
| Purpose: |
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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.
...
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| Study Summary: |
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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.
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| Criteria: |
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- 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.
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| NCT ID: |
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NCT00921999 |
| Primary Contact: |
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Principal Investigator
Jeffrey I Cohen, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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