ShinglesNCT02704572
Optimal Timing of Zoster Vaccine After Zoster Illness
A study testing Zostavax in people with Shingles, 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 patients aged over 50 with history of zoster within 5 years. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shingles
- 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
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Aug 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 50 years or older who have had shingles in 5 years
- Adults who did not receive zoster vaccination yet
- 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 had zoster vaccination already
- Adults who take immunosuppressants
- Human Immunodeficiency Virus (HIV) patients whose CD4 T cell counts below 500/mm3
- Adults with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
- Adults who had organ transplantation and receive immunosuppressants
- Adults who are suspected to have active infectious disease
- 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 Immune Response Induced by Zoster Vaccine According to the Timing of Vaccination After Zoster Illness
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 patients aged over 50 with history of zoster within 5 years.
Read the detailed description
Zoster vaccination is recommended by FDA for adults aged 60 years or older, and is approved for people aged 50 through 59 years old. For patients who had shingles, there is no specific length of time they must wait before receiving shingles vaccine. It is generally recommended that patients should wait for 6 to 12 months after recovery.
The investigators plan to make scientific recommendation for optimal timing of zoster vaccine after zoster illness by comparing immune response between two groups (vaccination at 6 months to 2 years after shingles vs. 2 to 5 years after shingles). Primary outcome is ELISPOT response at week 6 after vaccination. Secondary outcome is gpELISA titer at week 6 after vaccination.
All the patients will be asked if they have any contraindications 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).
- Conditions
- Shingles
- Being tested
- Zostavax
- Keywords
- Herpes zoster vaccine, cell-mediated immunity
- 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 |
|---|---|---|
| 6months to 2years after shingles | Experimental | Patients will be vaccinated with Zostavax from 6 months to 2 years after zoster illness. Receives: Biological: Zostavax |
| 2years to 5years after shingles | Active comparator | Patients will be vaccinated with Zostavax from 2 years to 5 years after zoster illness. 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 glycoprotein of varicella-zoster virus
Investigators measure the titer of VZV-specific glycoprotein-based 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 posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ShinglesStudies 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
- 60 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
- Wan Beom Park, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704572
- Sponsor's protocol ID
- H1511046718
- Status last verified
- Oct 2017
- First submitted
- 1 Mar 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gilbert PB, Gabriel EE, Hudgens MG, Miao X, Li X, Su SC, Parrino J, Chan IS. Reply to Dunning. J Infect Dis. 2015 Nov 1;212(9):1521-3. doi: 10.1093/infdis/jiv287. Epub 2015 May 17. No abstract available.
PubMed 25985906Levin 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 18419349Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
PubMed 20416263Kim 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 26546878Kang CI, Choi CM, Park TS, Lee DJ, Oh MD, Choe KW. Incidence of herpes zoster and seroprevalence of varicella-zoster virus in young adults of South Korea. Int J Infect Dis. 2008 May;12(3):245-7. doi: 10.1016/j.ijid.2007.08.002. Epub 2007 Oct 18.
PubMed 17950022Lee E, Chun JY, Song KH, Choe PG, Bang JH, Kim ES, Kim HB, Park SW, Kim NJ, Park WB, Oh MD. Optimal Timing of Zoster Vaccination After Shingles: A Prospective Study of the Immunogenicity and Safety of Live Zoster Vaccine. Infect Chemother. 2018 Dec;50(4):311-318. doi: 10.3947/ic.2018.50.4.311.
PubMed 30600654
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immune Response Induced by Zoster Vaccine According to the Timing of Vaccination After Zoster Illness
- ClinicalTrials.gov ID
- NCT02704572
- Acronym / sponsor ID
- H1511046718
- Conditions
- Shingles
- Keywords
- Herpes zoster vaccine, cell-mediated immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 10 Mar 2016 (estimated)
- 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 patients aged over 50 with history of zoster within 5 years.
Detailed description
Zoster vaccination is recommended by FDA for adults aged 60 years or older, and is approved for people aged 50 through 59 years old. For patients who had shingles, there is no specific length of time they must wait before receiving shingles vaccine. It is generally recommended that patients should wait for 6 to 12 months after recovery.
The investigators plan to make scientific recommendation for optimal timing of zoster vaccine after zoster illness by comparing immune response between two groups (vaccination at 6 months to 2 years after shingles vs. 2 to 5 years after shingles). Primary outcome is ELISPOT response at week 6 after vaccination. Secondary outcome is gpELISA titer at week 6 after vaccination.
All the patients will be asked if they have any contraindications 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6months to 2years after shingles | Experimental | Biological: ZostavaxPatients will be vaccinated with Zostavax from 6 months to 2 years after zoster illness. |
| 2years to 5years after shingles | Active comparator | Biological: ZostavaxPatients will be vaccinated with Zostavax from 2 years to 5 years after zoster illness. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 50 years or older who have had shingles in 5 years
- Adults who did not receive zoster vaccination yet
- Adults who can understand and agreed with the informed consents.
Key exclusion criteria (8 listed)
- Adults who have conditions which is contraindication for zoster vaccine
- Adults who had zoster vaccination already
- Adults who take immunosuppressants
- Human Immunodeficiency Virus (HIV) patients whose CD4 T cell counts below 500/mm3
- Adults with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
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 shingles, 6months to 2years after shingles |
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 glycoprotein of 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 13 Oct 2017.
- Background: PubMed 25985906Gilbert PB, Gabriel EE, Hudgens MG, Miao X, Li X, Su SC, Parrino J, Chan IS. Reply to Dunning. J Infect Dis. 2015 Nov 1;212(9):1521-3. doi: 10.1093/infdis/jiv287. Epub 2015 May 17. No abstract available.
- 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.
- Background: PubMed 20416263Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
- 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 17950022Kang CI, Choi CM, Park TS, Lee DJ, Oh MD, Choe KW. Incidence of herpes zoster and seroprevalence of varicella-zoster virus in young adults of South Korea. Int J Infect Dis. 2008 May;12(3):245-7. doi: 10.1016/j.ijid.2007.08.002. Epub 2007 Oct 18.
- Derived from this study: PubMed 30600654Lee E, Chun JY, Song KH, Choe PG, Bang JH, Kim ES, Kim HB, Park SW, Kim NJ, Park WB, Oh MD. Optimal Timing of Zoster Vaccination After Shingles: A Prospective Study of the Immunogenicity and Safety of Live Zoster Vaccine. Infect Chemother. 2018 Dec;50(4):311-318. doi: 10.3947/ic.2018.50.4.311.
- 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.
Wan Beom Park, 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 Shingles, 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 3 inclusion and 8 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 13 Oct 2017. 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 NCT02704572, which also lists 6 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 13 Oct 2017.