A Phase 4 interventional study of ZOSTAVAX in Shingles, sponsored by Louis Stokes VA Medical Center. Terminated. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Louis Stokes VA Medical Center · Phase 4, Interventional, and Basic science
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.
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.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
This study's enrollment of 22 is below the median of 160 across 247 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Louis Stokes VA Medical Center is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Indefinite duration palliative chemotherapy subjects
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection
Drug: ZOSTAVAX
There is no drug given in this arm.
Shingles vaccine
Also known as: Voster vaccine live
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.
Time frame: 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.
Time frame: 3 years
| Milestone | ZOSTAVAX | Control |
|---|---|---|
| Started | 10 | 12 |
| Completed | 10 | 12 |
| Not completed | 0 | 0 |
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.
| Participants | ZOSTAVAX | Control |
|---|---|---|
| Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT) | 0 | 0 |
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.
| Participants | ZOSTAVAX | Control |
|---|---|---|
| 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 | 2 | 0 |
Collected over We collected the data for the one month after giving the vaccine.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZOSTAVAX | 2/10 (20%) | 0/10 (0%) | 2/10 (20%) |
| Control | 4/12 (33.3%) | 0/12 (0%) | 0/12 (0%) |
| Event | ZOSTAVAX | Control |
|---|---|---|
| mild injection sorenessMusculoskeletal and connective tissue disorders | 2/10 | 0/12 |
| Age, Categorical(Participants) | ZOSTAVAX | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 5 | 7 |
| >=65 years | 8 | 7 | 15 |
| Age, Continuous(years) | ZOSTAVAX | Control | Total |
|---|---|---|---|
| Mean | 65.7 ± 6.6 | 64 ± 9.8 | 64.7 ± 8.3 |
| Sex: Female, Male(Participants) | ZOSTAVAX | Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 10 | 12 | 22 |
| Race (NIH/OMB)(Participants) | ZOSTAVAX | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 10 | 11 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | ZOSTAVAX | Control | Total |
|---|---|---|---|
| United States | 10 | 12 | 22 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2015 to primary completion in May 2018, 36 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Louis Stokes VA Medical Center