A Phase 4 interventional study of Zoster Vaccine Live in Shingles, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-05.
Sponsored by University of Washington · Phase 4, Interventional, and Basic science
The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).
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.
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's enrollment of 10 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Additional exclusions for optional skin biopsy:
10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)
Drug: Zoster Vaccine Live
Also known as: ZOSTAVAX
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
Time frame: 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
Time frame: 4 weeks
Number of Participants With Adverse Events Due to Zostavax
To measure the occurrence of adverse events after Zostavax.
Time frame: 6 months
Recruitment occurred from September 2016 to January 2018. Recruitment was done by placing flyers at retirement homes and by contacting persons over 70 who had previously been enrolled in research studies including giving informed written consent to be re contacted for future studies.
| Milestone | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood
| percentage of CD4 T cells | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood | 0.02 (0 to 0.07) |
To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax
| Percentage of CD4 T cells | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin | 0 (0 to 0.05) |
To measure the occurrence of adverse events after Zostavax.
| Participants | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Number of Participants With Adverse Events Due to Zostavax | 0 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
Person 70 and over receiving Zostavax
| Age, Continuous(years) | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Median | 74.5 (70 to 78) |
| Sex: Female, Male(Participants) | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Female | 7 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| United States | 10 |
| no history of shingles or shingles vaccination(Participants) | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Count of participants | 10 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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