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

Herpes Zoster Clinical Trial

Official title:

T Cell Responses to Varicella Zoster Virus After Vaccination and Viral Escape

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911065
• Other study ID #: SU-19385
• Secondary ID: 1U19AI090019-01
• Status: Completed
• Phase: Phase 4
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster

Intervention

Biological:
• Zostavax™
In the Vaccination arm, healthy individuals will be vaccinated with the licensed zoster vaccine, Zostavax.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Fang F, Yu M, Cavanagh MM, Hutter Saunders J, Qi Q, Ye Z, Le Saux S, Sultan W, Turgano E, Dekker CL, Tian L, Weyand CM, Goronzy JJ. Expression of CD39 on Activated T Cells Impairs their Survival in Older Individuals. Cell Rep. 2016 Feb 9;14(5):1218-1231. doi: 10.1016/j.celrep.2016.01.002. Epub 2016 Jan 28. — View Citation

Qi Q, Cavanagh MM, Le Saux S, NamKoong H, Kim C, Turgano E, Liu Y, Wang C, Mackey S, Swan GE, Dekker CL, Olshen RA, Boyd SD, Weyand CM, Tian L, Goronzy JJ. Diversification of the antigen-specific T cell receptor repertoire after varicella zoster vaccination. Sci Transl Med. 2016 Mar 30;8(332):332ra46. doi: 10.1126/scitranslmed.aaf1725. — View Citation

Qi Q, Cavanagh MM, Le Saux S, Wagar LE, Mackey S, Hu J, Maecker H, Swan GE, Davis MM, Dekker CL, Tian L, Weyand CM, Goronzy JJ. Defective T Memory Cell Differentiation after Varicella Zoster Vaccination in Older Individuals. PLoS Pathog. 2016 Oct 20;12(10):e1005892. doi: 10.1371/journal.ppat.1005892. eCollection 2016 Oct. — View Citation

Wang C, Liu Y, Cavanagh MM, Le Saux S, Qi Q, Roskin KM, Looney TJ, Lee JY, Dixit V, Dekker CL, Swan GE, Goronzy JJ, Boyd SD. B-cell repertoire responses to varicella-zoster vaccination in human identical twins. Proc Natl Acad Sci U S A. 2015 Jan 13;112(2):500-5. doi: 10.1073/pnas.1415875112. Epub 2014 Dec 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identify Predictors That Correlate With a Rapid and Diverse T Cell Response.	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.	0 to 14 Days
Primary	Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV		Day 0 to Day 35
Secondary	Number of Participants With Related Adverse Events		0 to 35 Days

External Links

•   Stanford LPCH Vaccine Program Clinical Trials Website