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| ID | Type | Description | Link |
|---|---|---|---|
| 53354 | Other Grant/Funding Number | Merck |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine Live | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Due to Zostavax | To measure the occurrence of adverse events after Zostavax. | 6 months |
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Inclusion Criteria:
Exclusion Criteria
Additional exclusions for optional skin biopsy:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Virology Research Clinic | Seattle | Washington | 98104 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) | We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Person 70 and over receiving Zostavax
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| ID | Title | Description |
|---|---|---|
| BG000 | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) | We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 10 persons 70 and older who received Zostavax | Posted | Median | Inter-Quartile Range | percentage of CD4 T cells | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) | We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Johnston, Associate Professor | University of Washington | 206 520 4340 | cjohnsto@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2015 | Nov 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| no history of shingles or shingles vaccination | Count of Participants | Participants |
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| Participants |
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | Percentage of CD4 T cells | 4 weeks |
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| Secondary | Number of Participants With Adverse Events Due to Zostavax | To measure the occurrence of adverse events after Zostavax. | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |