Herpes ZosterNCT03192319
Optimal Timing of Zoster Vaccine After Hematopoietic Stem Cell Transplantation
A study testing Zostavax in people with Herpes Zoster, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the optimal timing of zoster vaccination to induce both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with history of hematopoietic stem cell transplantation(HSCT). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Zostavax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2017to 23 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 50 years or older who is at least 2 years after hematopoietic stem cell transplantation (Experimental group)
- Adults aged 50 years or older who is at least 6 months after being cured by chemotherapy for leukemia (Control group)
- Healthy Adults aged 50 years or older who do not meet exclusion criteria (Control group)
- Adults who can understand and agreed with the informed consents
Who cannot join
- Adults who have conditions which is contraindication for zoster vaccine
- Adults who take immunosuppressant
- Adults with graft versus host disease(GVHD)
- Adults who take antivirals agent
- Adults who experienced VZV infection after hematopoietic stem cell transplantation
- Adults who received VZV vaccination already after hematopoietic stem cell transplantation
- Adults who are not eligible for zoster vaccination by investigator's assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation
The purpose of this study is to determine the optimal timing of zoster vaccination to induce both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with history of hematopoietic stem cell transplantation(HSCT).
Read the detailed description
Due to lack of data on safety of live vaccine in the recipient of hematopoietic stem cell transplantation, CIBMTR(Center for International Blood and Marrow Transplant Research) guidelines recommend varicella vaccination only in patients who is at least two years after transplantation and without graft versus host disease and no immunosuppressive drug.
However, recent studies have demonstrated the safety and efficacy of shingles vaccination in patients receiving hematopoietic stem cell transplantation.
But, there is no basis for timing of live vaccine administration after HSCT.
The investigators plan to make scientific recommendation for optimal timing of zoster vaccine after HSCT by comparing immune response between two groups(vaccination at 2 to 5years after HSCT vs. 5 to 10years after HSCT). Primary outcome is interferon gamma releasing ELISPOT response at week 6 after vaccination. Secondary outcome is ELISA titer for zoster-specific IgG at week 6 after vaccination.
All the patients will be asked if they have any contraindication for zoster vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 6 weeks(visiting the hospital).
In order to confirm the efficacy of the experiment, 30 healthy controls and 30 patients who were treated with chemotherapy alone for leukemia were selected. The control group will also apply the same protocol as above.
- Conditions
- Herpes Zoster
- Being tested
- Zostavax
- Keywords
- Herpes zoster vaccine, Cell-mediated immunity, hematopoietic stem cell transplantation
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZostavaxBiological
Zostavax will be administrated by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 2years to 5years after HCT | Experimental | Patients will be vaccinated with Zostavax from 2years to 5years after hematopoietic stem cell transplantation Receives: Biological: Zostavax |
| 5years to 10years after HCT | Active comparator | Patients will be vaccinated with Zostavax from 5years to 10years after hematopoietic stem cell transplantation Receives: Biological: Zostavax |
| 6 month after chemotherapy for leukemia | Active comparator | Patients will be vaccinated with Zostavax 6 months after the leukemia is cured with chemotherapy Receives: Biological: Zostavax |
| healthy people | Active comparator | Healthy adults over 50 years old will be vaccinated with Zostavax Receives: Biological: Zostavax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Varicella-zoster virus-specific interferon-gamma ELISPOT response
Investigators measure the number of SFC(spot forming cells) using interferon-gamma ELISPOT(enzyme-linked immunospot) assay at both right before vaccination and week 6 after vaccination and see the change between two values.
Measured: before Zostavax vaccination and at week 6 after vaccination
Secondary outcomes (1)
Antibody titer against varicella-zoster virus
Investigators measure the titer of Varicella zoster virus (VZV)-specific Ab by enzyme-linked immunosorbent assay at both right before vaccination and week 6 after vaccination and see the fold change between two values
Measured: before Zostavax vaccination and at week 6 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Jul 2017
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Beom Park, Seoul National University Hospital
- Investigators
- Park Wan Beom, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192319
- Sponsor's protocol ID
- H1705030852
- Status last verified
- Apr 2019
- First submitted
- 16 Jun 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tomblyn M, Chiller T, Einsele H, Gress R, Sepkowitz K, Storek J, Wingard JR, Young JA, Boeckh MJ; Center for International Blood and Marrow Research; National Marrow Donor program; European Blood and MarrowTransplant Group; American Society of Blood and Marrow Transplantation; Canadian Blood and Marrow Transplant Group; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America; Association of Medical Microbiology and Infectious Disease Canada; Centers for Disease Control and Prevention. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow Transplant. 2009 Oct;15(10):1143-238. doi: 10.1016/j.bbmt.2009.06.019. No abstract available.
PubMed 19747629Issa NC, Marty FM, Leblebjian H, Galar A, Shea MM, Antin JH, Soiffer RJ, Baden LR. Live attenuated varicella-zoster vaccine in hematopoietic stem cell transplantation recipients. Biol Blood Marrow Transplant. 2014 Feb;20(2):285-7. doi: 10.1016/j.bbmt.2013.11.013. Epub 2013 Nov 22.
PubMed 24269706Gilbert PB, Gabriel EE, Miao X, Li X, Su SC, Parrino J, Chan IS. Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve. J Infect Dis. 2014 Nov 15;210(10):1573-81. doi: 10.1093/infdis/jiu279. Epub 2014 May 13.
PubMed 24823623Kim JW, Min CK, Mun YC, Park Y, Kim BS, Nam SH, Koh Y, Kwon JH, Choe PG, Park WB, Kim I. Varicella-zoster virus-specific cell-mediated immunity and herpes zoster development in multiple myeloma patients receiving bortezomib- or thalidomide-based chemotherapy. J Clin Virol. 2015 Dec;73:64-69. doi: 10.1016/j.jcv.2015.10.018. Epub 2015 Oct 24.
PubMed 26546878Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR, Caulfield MJ, Irwin MR, Smith JG, Clair J, Chan IS, Williams H, Harbecke R, Marchese R, Straus SE, Gershon A, Weinberg A; Veterans Affairs Cooperative Studies Program Shingles Prevention Study Investigators. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis. 2008 Mar 15;197(6):825-35. doi: 10.1086/528696.
PubMed 18419349
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03192319
- Acronym / sponsor ID
- H1705030852
- Conditions
- Herpes Zoster
- Keywords
- Herpes zoster vaccine, Cell-mediated immunity, hematopoietic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the optimal timing of zoster vaccination to induce both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with history of hematopoietic stem cell transplantation(HSCT).
Detailed description
Due to lack of data on safety of live vaccine in the recipient of hematopoietic stem cell transplantation, CIBMTR(Center for International Blood and Marrow Transplant Research) guidelines recommend varicella vaccination only in patients who is at least two years after transplantation and without graft versus host disease and no immunosuppressive drug.
However, recent studies have demonstrated the safety and efficacy of shingles vaccination in patients receiving hematopoietic stem cell transplantation.
But, there is no basis for timing of live vaccine administration after HSCT.
The investigators plan to make scientific recommendation for optimal timing of zoster vaccine after HSCT by comparing immune response between two groups(vaccination at 2 to 5years after HSCT vs. 5 to 10years after HSCT). Primary outcome is interferon gamma releasing ELISPOT response at week 6 after vaccination. Secondary outcome is ELISA titer for zoster-specific IgG at week 6 after vaccination.
All the patients will be asked if they have any contraindication for zoster vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 6 weeks(visiting the hospital).
In order to confirm the efficacy of the experiment, 30 healthy controls and 30 patients who were treated with chemotherapy alone for leukemia were selected. The control group will also apply the same protocol as above.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2years to 5years after HCT | Experimental | Biological: ZostavaxPatients will be vaccinated with Zostavax from 2years to 5years after hematopoietic stem cell transplantation |
| 5years to 10years after HCT | Active comparator | Biological: ZostavaxPatients will be vaccinated with Zostavax from 5years to 10years after hematopoietic stem cell transplantation |
| 6 month after chemotherapy for leukemia | Active comparator | Biological: ZostavaxPatients will be vaccinated with Zostavax 6 months after the leukemia is cured with chemotherapy |
| healthy people | Active comparator | Biological: ZostavaxHealthy adults over 50 years old will be vaccinated with Zostavax |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 50 years or older who is at least 2 years after hematopoietic stem cell transplantation (Experimental group)
- Adults aged 50 years or older who is at least 6 months after being cured by chemotherapy for leukemia (Control group)
- Healthy Adults aged 50 years or older who do not meet exclusion criteria (Control group)
- Adults who can understand and agreed with the informed consents
Key exclusion criteria (7 listed)
- Adults who have conditions which is contraindication for zoster vaccine
- Adults who take immunosuppressant
- Adults with graft versus host disease(GVHD)
- Adults who take antivirals agent
- Adults who experienced VZV infection after hematopoietic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZostavaxZostavax will be administrated by subcutaneous injection | Biological | 2years to 5years after HCT, 5years to 10years after HCT, 6 month after chemotherapy for leukemia, healthy people |
Primary outcome
Varicella-zoster virus-specific interferon-gamma ELISPOT response
Time frame: before Zostavax vaccination and at week 6 after vaccination
Investigators measure the number of SFC(spot forming cells) using interferon-gamma ELISPOT(enzyme-linked immunospot) assay at both right before vaccination and week 6 after vaccination and see the change between two values.
1 secondary outcome
Antibody titer against varicella-zoster virus
Time frame: before Zostavax vaccination and at week 6 after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 19747629Tomblyn M, Chiller T, Einsele H, Gress R, Sepkowitz K, Storek J, Wingard JR, Young JA, Boeckh MJ; Center for International Blood and Marrow Research; National Marrow Donor program; European Blood and MarrowTransplant Group; American Society of Blood and Marrow Transplantation; Canadian Blood and Marrow Transplant Group; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America; Association of Medical Microbiology and Infectious Disease Canada; Centers for Disease Control and Prevention. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow Transplant. 2009 Oct;15(10):1143-238. doi: 10.1016/j.bbmt.2009.06.019. No abstract available.
- Background: PubMed 24269706Issa NC, Marty FM, Leblebjian H, Galar A, Shea MM, Antin JH, Soiffer RJ, Baden LR. Live attenuated varicella-zoster vaccine in hematopoietic stem cell transplantation recipients. Biol Blood Marrow Transplant. 2014 Feb;20(2):285-7. doi: 10.1016/j.bbmt.2013.11.013. Epub 2013 Nov 22.
- Background: PubMed 24823623Gilbert PB, Gabriel EE, Miao X, Li X, Su SC, Parrino J, Chan IS. Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve. J Infect Dis. 2014 Nov 15;210(10):1573-81. doi: 10.1093/infdis/jiu279. Epub 2014 May 13.
- Background: PubMed 26546878Kim JW, Min CK, Mun YC, Park Y, Kim BS, Nam SH, Koh Y, Kwon JH, Choe PG, Park WB, Kim I. Varicella-zoster virus-specific cell-mediated immunity and herpes zoster development in multiple myeloma patients receiving bortezomib- or thalidomide-based chemotherapy. J Clin Virol. 2015 Dec;73:64-69. doi: 10.1016/j.jcv.2015.10.018. Epub 2015 Oct 24.
- Background: PubMed 18419349Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR, Caulfield MJ, Irwin MR, Smith JG, Clair J, Chan IS, Williams H, Harbecke R, Marchese R, Straus SE, Gershon A, Weinberg A; Veterans Affairs Cooperative Studies Program Shingles Prevention Study Investigators. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis. 2008 Mar 15;197(6):825-35. doi: 10.1086/528696.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Park Wan Beom, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zostavax in people with Herpes Zoster, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 7 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 4 Apr 2019. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Varicella-zoster virus-specific interferon-gamma ELISPOT response (time frame: before Zostavax vaccination and at week 6 after vaccination). 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 NCT03192319, which also lists 5 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 4 Apr 2019.