ShinglesPhase 4NCT02444936
ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
A Phase 4 study testing ZOSTAVAX in people with Shingles, run by Louis Stokes VA Medical Center.
Trial summary
This study evaluates if the shingles vaccine works in those persons that receive it before they receive chemotherapy for solid organ tumors. Half of the participants will receive the ZOSTAVAX shingle vaccine and half of the participants will not received anything. Read more about this study
- Who is it for?
- Ages 50 years and older
- 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
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 May 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid organ tumor patients that have at least 14 days between entry into the study with ZOSTAVAX vaccination and initial therapy for their malignancy that will include chemotherapy alone or surgery with subsequent chemotherapy plus or minus radiation therapy
- A plan for chemotherapy that at the onset at least an anticipated stop date within 3-6 months of our sample collection phase of the study
Who cannot join
- Prior history of HZ or shingles vaccine
- Systemic chemotherapy < 3 months prior to enrollment
- Any history of hematologic malignancy, HIV/AIDS, hematopoietic stem cell transplant, or other cellular immunodeficiency state
- Those receiving immunomodulating drugs at the time of vaccination such as prednisone methotrexate, azathioprine, mercaptopurine, or other biologics including TNF-alpha inhibitors
- Widespread metastatic tumor with bone marrow involvement
- Indefinite duration palliative chemotherapy subjects
- Inability to communicate with the study staff or bring unable to consent for themselves
- History of anaphylactic/anaphylactiod reaction to gelatin, neomycin, or other components of the vaccine
About this study
Official title: A Pilot Study Using a Randomized Design to Evaluate the Immunologic Efficacy and Safety of ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
This study evaluates if the shingles vaccine works in those persons that receive it before they receive chemotherapy for solid organ tumors. Half of the participants will receive the ZOSTAVAX shingle vaccine and half of the participants will not received anything.
Read the detailed description
This study is a single blind randomized clinical trial measuring the immunologic efficacy of ZOSTAVAX vs. no vaccine in 60 adults with solid organ tumors before, during and after chemotherapy. The personnel performing the laboratory studies will be blinded to vaccine vs. no vaccine. In a pilot study of an FDA approved vaccine that is being used within the parameters of the package insert and ACIP recommendations, placebo vaccine is not required to access our key primary immunologic endpoint.
- Conditions
- Shingles
- Being tested
- ZOSTAVAX
- Keywords
- solid tumor, chemotherapy, vaccine
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOSTAVAXDrug
Also called Voster vaccine live
Shingles vaccine
| Study group | Role | What they receive |
|---|---|---|
| ZOSTAVAX | Active comparator | ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection Receives: Drug: ZOSTAVAX |
| Control | No intervention | There is no drug given in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)
To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.
Measured: 3 years
Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures
To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study start1 May 2015
- Primary completion1 May 2018
- Study completion1 May 2018
Why it stopped: unable to obtain samples of key groups to do any analysis.
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Duke University
- Responsible party
- Principal investigator, David Canaday, Louis Stokes VA Medical Center
- Investigators
- David H. Canaday, MD, Principal investigator, Cleveland VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444936
- Sponsor's protocol ID
- Canaday Zostavax
- Status last verified
- Sep 2026
- First submitted
- 7 May 2015
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using a Randomized Design to Evaluate the Immunologic Efficacy and Safety of ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
- ClinicalTrials.gov ID
- NCT02444936
- Acronym / sponsor ID
- Canaday Zostavax
- Conditions
- Shingles
- Keywords
- solid tumor, chemotherapy, vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to obtain samples of key groups to do any analysis.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Collaborators
- Duke University
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Posted 6 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if the shingles vaccine works in those persons that receive it before they receive chemotherapy for solid organ tumors. Half of the participants will receive the ZOSTAVAX shingle vaccine and half of the participants will not received anything.
Detailed description
This study is a single blind randomized clinical trial measuring the immunologic efficacy of ZOSTAVAX vs. no vaccine in 60 adults with solid organ tumors before, during and after chemotherapy. The personnel performing the laboratory studies will be blinded to vaccine vs. no vaccine. In a pilot study of an FDA approved vaccine that is being used within the parameters of the package insert and ACIP recommendations, placebo vaccine is not required to access our key primary immunologic endpoint.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZOSTAVAX | Active comparator | Drug: ZOSTAVAXZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection |
| Control | No intervention | –There is no drug given in this arm. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Solid organ tumor patients that have at least 14 days between entry into the study with ZOSTAVAX vaccination and initial therapy for their malignancy that will include chemotherapy alone or surgery with subsequent chemotherapy plus or minus radiation therapy
- A plan for chemotherapy that at the onset at least an anticipated stop date within 3-6 months of our sample collection phase of the study
Key exclusion criteria (8 listed)
- Prior history of HZ or shingles vaccine
- Systemic chemotherapy < 3 months prior to enrollment
- Any history of hematologic malignancy, HIV/AIDS, hematopoietic stem cell transplant, or other cellular immunodeficiency state
- Those receiving immunomodulating drugs at the time of vaccination such as prednisone methotrexate, azathioprine, mercaptopurine, or other biologics including TNF-alpha inhibitors
- Widespread metastatic tumor with bone marrow involvement
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 |
|---|---|---|
| ZOSTAVAXAlso: Voster vaccine liveShingles vaccine | Drug | ZOSTAVAX |
Primary outcome
Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)
Time frame: 3 years
To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.
Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures
Time frame: 3 years
To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David H. Canaday, MD principal investigator
Cleveland VA
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ZOSTAVAX in people with Shingles, run by Louis Stokes VA Medical Center.
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 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: stopped early, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 6 Apr 2018). 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?
Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT) (time frame: 3 years). 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 23 Sep 2026.