T Cell Responses to Varicella Zoster Virus (VZV)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University
ClinicalTrials.gov Identifier:
NCT01911065
First received: July 17, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

With increasing age, immune responses to vaccination begin to decline. A decrease in vaccination success rates is already evident in the 6th and 7th decade of life. With the changing demographics of the US population, this decline in immune function is a major health concern.

The study of the immune responses to the naturally-acquired chicken pox virus and to the shingles vaccine will provide an important opportunity to learn more about the aging immune system and may lead to an improvement in vaccination strategies and identification of ways to improve vaccine responses in older individuals


Condition Intervention Phase
Immune Response to Zoster Vaccine
Biological: Zostavax™
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Stanford University:

Primary Outcome Measures:
  • To measure change in varicella zoster virus (VZV)-specific T cell frequencies [ Time Frame: Day 0 to Day 28 ] [ Designated as safety issue: No ]
    This will be measured by IFN-gamma ELISpot assay (a type of immunological assay)

  • Measure antibody titers on day 28 [ Time Frame: Day 0 to Day 28 ] [ Designated as safety issue: No ]
    The antibody titers will be measured by IgG ELISA assay ( a type of immunological assay)


Estimated Enrollment: 150
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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™
Other Name: Zoster Vaccine Live
No Intervention: Cross-sectional group
Participants 40-49 years of age will not receive any intervention

Detailed Description:

The objective of this protocol is 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.

The study is divided in 2 specific cohorts.

In the first cohort (cross-sectional study), the objective is to examine 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). Volunteers in this cohort will be identical twins and non-twins 40-49 years of age and will not be vaccinated with the licensed zoster vaccine. (Zostavax vaccine is approved only for individuals who are 50 years and above)

In the second cohort (vaccination study), healthy identical twin and non-twins who are 50 and above will be vaccinated with the licensed zoster vaccine, Zostavax. We will compare age-related and inherited vaccine responses focusing on factors that control the initiation of the T-cell immune response and T cell signatures at peak response that correlate with T cell memory development and antibody production. To assess VZV viremia, we will test for VZV by PCR at 5 study time points.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy adult, 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 12. 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
Investigators
Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Jorg J Goronzy, MD, PhD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01911065     History of Changes
Other Study ID Numbers: SU-19385, 1U19AI090019-01
Study First Received: July 17, 2013
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Stanford University:
Herpes zoster
chicken pox
immune response
Zostavax

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

ClinicalTrials.gov processed this record on August 26, 2014