Clinical trial · Interventional
ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Why stopped (as posted): unable to obtain samples of key groups to do any analysis.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Shingles | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZOSTAVAX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ZOSTAVAX
- description
- ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection
- interventionNames
- Drug: ZOSTAVAX
- type
- NO_INTERVENTION
- label
- Control
- description
- There is no drug given in this arm.
Primary outcomes (2)
- measure
- Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available