ShinglesPhase 4NCT02624375
Immune Response to Shingles Vaccination
A Phase 4 study testing Zoster Vaccine Live in people with Shingles, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shingles
- What is being tested?
- Zoster Vaccine Live
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Nov 2019
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 70 years of age or older.
- History of chickenpox.
Who cannot join
- Previous vaccination with Zostavax or with the chickenpox vaccine.
- History of ever having had shingles.
- Been in close contact with a person who had chickenpox or shingles in the past 5 years.
- VZV seronegative
- Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations.
- HIV seropositive.
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- Hepatitis C infection or active Hepatitis B infection.
- History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. Neomycin allergy manifested as contact dermatitis is not an exclusion.
- Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
- Has long-term use of oral or parenteral steroids (>7 days), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- Women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination
- Donated blood in the past 8 weeks or planning to donate blood during the study
- Weighs less than 110 lbs
- Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Additional exclusions for optional skin biopsy:
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
- History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
- History of keloid formation or excessive scarring
- History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
- Allergy to lidocaine, silver nitrate, or mupirocin.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Virology Research Clinic
Seattle, Washington, 98104
About this study
The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).
Read the detailed description
Participants 70 years of age or older will receive the FDA-approved shingles vaccine (Zostavax). Blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.
- Conditions
- Shingles
- Being tested
- Zoster Vaccine Live
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoster Vaccine LiveDrug
Also called ZOSTAVAX
| Study group | Role | What they receive |
|---|---|---|
| 10 persons over 70 years of age that received Zostavax | Experimental | 10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm) Receives: Drug: Zoster Vaccine Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood
Measured: 6 months
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax
Measured: 4 weeks
Secondary outcomes (1)
Number of Participants With Adverse Events Due to Zostavax
To measure the occurrence of adverse events after Zostavax.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ShinglesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Christine Johnston, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624375
- Sponsor's protocol ID
- STUDY00001399
- Other IDs
- 53354
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2015
- Last updated
- 5 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Shingles Vaccination
- ClinicalTrials.gov ID
- NCT02624375
- Acronym / sponsor ID
- STUDY00001399
- Conditions
- Shingles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Posted 5 Dec 2019
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 learn more about the immune response to varicella zoster virus (VZV).
Detailed description
Participants 70 years of age or older will receive the FDA-approved shingles vaccine (Zostavax). Blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10 persons over 70 years of age that received Zostavax | Experimental | Drug: Zoster Vaccine Live10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 70 years of age or older.
- History of chickenpox.
Key exclusion criteria (20 listed)
- Previous vaccination with Zostavax or with the chickenpox vaccine.
- History of ever having had shingles.
- Been in close contact with a person who had chickenpox or shingles in the past 5 years.
- VZV seronegative
- Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations.
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 |
|---|---|---|
| Zoster Vaccine LiveAlso: ZOSTAVAX | Drug | 10 persons over 70 years of age that received Zostavax |
Primary outcome
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
Time frame: 6 months
To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
Time frame: 4 weeks
To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax
1 secondary outcome
Number of Participants With Adverse Events Due to Zostavax
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoster Vaccine Live in people with Shingles, run by University of Washington 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 2 inclusion and 20 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 5 Dec 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 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 5 Dec 2019). 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?
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2019.