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T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University
ClinicalTrials.gov Identifier:
NCT01911065
First received: July 17, 2013
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
In this study the investigators are trying to identify immune signatures that are associated with effective or poor vaccine responses to naturally-acquired herpes zoster virus and the zoster (shingles) vaccine, Zostavax.

Condition Intervention Phase
Herpes Zoster Biological: Zostavax™ Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: T Cell Responses to Varicella Zoster Virus After Vaccination and Viral Escape

Resource links provided by NLM:


Further study details as provided by Cornelia L. Dekker, Stanford University:

Primary Outcome Measures:
  • Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV [ Time Frame: Day 0 to Day 35 ]

Secondary Outcome Measures:
  • Number of Participants With Related Adverse Events [ Time Frame: 0 to 35 Days ]

Other Outcome Measures:
  • Identify Predictors That Correlate With a Rapid and Diverse T Cell Response. [ Time Frame: 0 to 14 Days ]
    The investigators will use the frequency and TCR diversity of VZV-specific T cells on days 7 and 14 after vaccination as outcome variable and identify predictors that positively or negatively correlate with a rapid and diverse T cell response in the different age groups.


Enrollment: 54
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zostavax™ vaccine group
Participants > 50 years will receive a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
Biological: Zostavax™
In the Vaccination arm, healthy individuals will be vaccinated with the licensed zoster vaccine, Zostavax.
Other Name: Zoster Vaccine Live
No Intervention: Natural-acquired VZV immunity
Participants 40-49 years of age will not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).

Detailed Description:
This study will examine the frequency, phenotype and repertoire of VZV-specific T cells. The frequency and T-Cell Receptor (TCR) diversity of VZV-specific T cells on days 7 and 14 after vaccination will be examined. The titer of anti-VZV antibodies and T cell frequencies will be examined on day 28 post vaccination.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy adult non-twins and twin pairs, 40-49 years of age (Cross-Sectional study) or 50 years of age and older (Vaccination study). If a volunteer cannot participate in the Vaccination study after screening, may be considered for Cross-Sectional study.
  • History of prior chicken pox infection or living within the continental U.S. for past 30 years
  • Willing to complete the informed consent process
  • Availability for follow-up for the planned duration of the study (Cross-Sectional study: 1 visit; Vaccination study: 5 visits within 4-5 weeks)
  • Acceptable medical history and vital signs

Exclusion Criteria:

  • History of shingles within 5 years of enrollment
  • Prior vaccination with Zostavax vaccine for prevention of shingles
  • Vaccination Study only: History of severe allergic reactions to vaccine components, including gelatin and neomycin.
  • Vaccination Study only: Life-threatening reactions to previous vaccinations.
  • Vaccination Study only: Adults weighing less than 110 pounds.
  • Active systemic or serious concurrent illness, including febrile illness on the day of enrollment/vaccination
  • History of immunodeficiency disorder
  • Chronic HIV, Hepatitis B or Hepatitis C infection
  • Known or suspected impairment of immunologic function, including, but not limited to clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  • Recent or current use of immunosuppressive medication, or anticipated use during study period, including systemic corticosteroids (corticosteroid nasal sprays, inhaled steroids and topical steroids are permissible).
  • Blood pressure >150 systolic or > 95 diastolic at Visit 1
  • History of chemotherapy treatment for cancer.
  • Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer with recurrence in the past year and any hematologic cancer such as leukemia or lymphoma) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol. Prostate cancer may be acceptable if no metastases and not undergoing treatment with immunosuppressive medications.
  • Autoimmune disease, including rheumatoid arthritis, treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel, which in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol (thyroid disease may be acceptable).
  • History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  • Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except aspirin up to 325 mg. daily), Plavix or Aggrenox which may, in the opinion of the investigator, jeopardize volunteer safety or compliance with the protocol.
  • Receipt of blood or blood products within 6 months prior to enrollment and during the study period
  • Use of antiviral medications within 24 hrs. prior to enrollment, and for the Vaccination study, for the 14 days following study vaccination.
  • Inactivated vaccine within 14 days prior to enrollment and during study period(avoid non-study related immunization during the study period)
  • Live, attenuated vaccine within 60 days prior to enrollment and during study period (avoid non-study related immunization during the study period)
  • Pregnant or lactating woman, planning to become pregnant (pregnancy should be avoided for 3 months following administration of Zostavax vaccine).
  • Use of investigational agents within 30 days prior to enrollment and during study period
  • Donation of a unit of blood within 6 weeks prior to enrollment and during study period
  • Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
  • Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911065

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Jorg J Goronzy, MD, PhD Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01911065     History of Changes
Other Study ID Numbers: SU-19385
1U19AI090019-01 ( U.S. NIH Grant/Contract )
Study First Received: July 17, 2013
Results First Received: January 11, 2017
Last Updated: April 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cornelia L. Dekker, Stanford University:
Herpes zoster
immune response
Zostavax
twins
non-twins

Additional relevant MeSH terms:
Herpes Zoster
Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2017