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Herpes ZosterPhase 4NCT01911065

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

A Phase 4 study testing Zostavax™ in people with Herpes Zoster, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Herpes Zoster
What is being tested?
Zostavax™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Sep 2010to Dec 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Herpes Zoster
Being tested
Zostavax™
Keywords
Herpes zoster, immune response, Zostavax, twins, non-twins
Medical subject headings
Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zostavax™Biological

    Also called Zoster Vaccine Live

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

Study groups in NCT01911065
Study groupRoleWhat they receive
Zostavax™ vaccine groupExperimentalParticipants > 50 years will receive a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
Receives: Biological: Zostavax™
Natural-acquired VZV immunityNo interventionParticipants 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV

    Measured: Day 0 to Day 35

Secondary outcomes (1)

  1. Number of Participants With Related Adverse Events

    Measured: 0 to 35 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2013 (estimated)
  2. Study startSep 2010
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01911065
Sponsor's protocol ID
SU-19385
Other IDs
1U19AI090019-01
Status last verified
Nov 2023
First submitted
17 Jul 2013
Last updated
18 Dec 2023
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25535378

  • 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.

    PubMed 26832412

  • 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.

    PubMed 27030598

  • 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.

    PubMed 27764254

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zostavax™ in people with Herpes Zoster, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV (time frame: Day 0 to Day 35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01911065, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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