Overview

This trial is active, not recruiting.

Condition immune response to zoster vaccine
Treatment zostavax™
Phase phase 4
Sponsor Stanford University
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date June 2010
End date December 2014
Trial size 150 participants
Trial identifier NCT01911065, 1U19AI090019-01, SU-19385

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants > 50 years will receive a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
zostavax™ Zoster Vaccine Live
(No Intervention)
Participants 40-49 years of age will not receive any intervention

Primary Outcomes

Measure
To measure change in varicella zoster virus (VZV)-specific T cell frequencies
time frame: Day 0 to Day 28
Measure antibody titers on day 28
time frame: Day 0 to Day 28

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

Official title T Cell Responses to Varicella Zoster Virus After Vaccination and Viral Escape
Principal investigator Cornelia L Dekker, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Stanford University.