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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19AI090019-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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In this study the investigators are trying to identify immune signatures that are associated with effective or poor vaccine responses to naturally-acquired herpes zoster virus and the zoster (shingles) vaccine, Zostavax.
This study will examine the frequency, phenotype and repertoire of VZV-specific T cells. The frequency and T-Cell Receptor (TCR) diversity of VZV-specific T cells on days 7 and 14 after vaccination will be examined. The titer of anti-VZV antibodies and T cell frequencies will be examined on day 28 post vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zostavax™ vaccine group | Experimental | Participants > 50 years will receive a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection. |
|
| Natural-acquired VZV immunity | No Intervention | Participants 40-49 years of age will not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zostavax™ | Biological | In the Vaccination arm, healthy individuals will be vaccinated with the licensed zoster vaccine, Zostavax. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV | Day 0 to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Adverse Events | 0 to 35 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Identify Predictors That Correlate With a Rapid and Diverse T Cell Response. | The investigators will use the frequency and TCR diversity of VZV-specific T cells on days 7 and 14 after vaccination as outcome variable and identify predictors that positively or negatively correlate with a rapid and diverse T cell response in the different age groups. | 0 to 14 Days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia L Dekker, MD | Stanford University | Principal Investigator |
| Jorg J Goronzy, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25535378 | Background | Wang C, Liu Y, Cavanagh MM, Le Saux S, Qi Q, Roskin KM, Looney TJ, Lee JY, Dixit V, Dekker CL, Swan GE, Goronzy JJ, Boyd SD. B-cell repertoire responses to varicella-zoster vaccination in human identical twins. Proc Natl Acad Sci U S A. 2015 Jan 13;112(2):500-5. doi: 10.1073/pnas.1415875112. Epub 2014 Dec 22. | |
| 26832412 | Background | Fang F, Yu M, Cavanagh MM, Hutter Saunders J, Qi Q, Ye Z, Le Saux S, Sultan W, Turgano E, Dekker CL, Tian L, Weyand CM, Goronzy JJ. Expression of CD39 on Activated T Cells Impairs their Survival in Older Individuals. Cell Rep. 2016 Feb 9;14(5):1218-1231. doi: 10.1016/j.celrep.2016.01.002. Epub 2016 Jan 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zostavax™ Vaccine Group | Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection. |
| FG001 | Naturally-acquired VZV Immunity | Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zostavax™ Vaccine Group | Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection. |
| BG001 | Naturally-acquired VZV Immunity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV | Posted | Count of Participants | Participants | Day 0 to Day 35 |
|
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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 | Zostavax™ Vaccine Group | Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Resolved without sequelae |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cornelia Dekker | Stanford University School of Medicine, Dept. of Pediatrics | 650-724-4437 | cdekker@stanford.edu |
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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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| 27030598 | Background | Qi Q, Cavanagh MM, Le Saux S, NamKoong H, Kim C, Turgano E, Liu Y, Wang C, Mackey S, Swan GE, Dekker CL, Olshen RA, Boyd SD, Weyand CM, Tian L, Goronzy JJ. Diversification of the antigen-specific T cell receptor repertoire after varicella zoster vaccination. Sci Transl Med. 2016 Mar 30;8(332):332ra46. doi: 10.1126/scitranslmed.aaf1725. |
| 27764254 | Background | Qi Q, Cavanagh MM, Le Saux S, Wagar LE, Mackey S, Hu J, Maecker H, Swan GE, Davis MM, Dekker CL, Tian L, Weyand CM, Goronzy JJ. Defective T Memory Cell Differentiation after Varicella Zoster Vaccination in Older Individuals. PLoS Pathog. 2016 Oct 20;12(10):e1005892. doi: 10.1371/journal.ppat.1005892. eCollection 2016 Oct. |
Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Number of Participants With Related Adverse Events | Posted | Count of Participants | Participants | 0 to 35 Days |
|
|
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| Other Pre-specified | Identify Predictors That Correlate With a Rapid and Diverse T Cell Response. | The investigators will use the frequency and TCR diversity of VZV-specific T cells on days 7 and 14 after vaccination as outcome variable and identify predictors that positively or negatively correlate with a rapid and diverse T cell response in the different age groups. | Not Posted | 0 to 14 Days | Participants |
| 0 |
| 45 |
| 3 |
| 45 |
| EG001 | Naturally-acquired VZV Immunity | Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox). | 0 | 9 | 0 | 9 |
|
| Herpes zoster | Skin and subcutaneous tissue disorders | Systematic Assessment | Herpes zoster developed 1 day following immunization; lesion isolate sent to CDC and was wild-type (not vaccine strain), resolved after prolonged PHN despite prompt antiviral treatment. VAERS report filed. |
|
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| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |