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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODNAP0016 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to characterize the immune response in vivo using approved vaccines and antigen challenges, as well as a skin wounding challenge to stimulate the immune system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Vaccine Challenge Imvanex | Experimental | Participants will receive single dose of Imvanex subcutaneously on Day 1. Participants will also be included in the DREEM EEG substudy. |
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| Cohort 2: Vaccine Challenge Shingrix | Experimental | Participants will receive single dose of Shingrix intramuscularly on Day 1. Participants will also be included in the DREEM EEG substudy. |
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| Cohort 3: Antigen Challenge Lipopolysaccharides (LPS) | Experimental | Participants will receive a single dose of LPS intravenously (IV) on Day 1. Participants will also be included in the DREEM EEG substudy and vital patch physIQ platform substudy. |
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| Cohort 4: Antigen Challenge Candin | Experimental | Participants will receive one single injection of Candin and one single injection of saline control intradermally on Day 1. Participants will also be included in the DREEM EEG substudy. |
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| Cohort 5: Skin Wounding Challenge | Experimental | 3 punch biopsies will be performed per standard dermatologic practice guidelines. Lower abdomen tissue biopsy specimens will be collected on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imvanex | Biological | Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 and Cohort 2: Change from Baseline of Immune Cell Populations | Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers. | Baseline up to 90 days |
| Cohort 3 and Cohort 4: Change from Baseline of Immune Cell Populations | Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers. | Baseline up to 14 days |
| Cohort 5: Change from Baseline of Immune Cell Populations | Change from baseline in immune cell populations will be measured in tissues of healthy volunteers. | Baseline up to 10 days |
| Cohort 1 and Cohort 2: Change from Baseline in Cell Surface Antigen Phenotype | Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers. | Baseline up to 90 days |
| Cohort 3 and Cohort 4: Change from Baseline in Cell Surface Antigen Phenotype | Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers. | Baseline up to 14 days |
| Cohort 5: Change from Baseline in Cell Surface Antigen Phenotype | Change from baseline in cell surface antigen phenotype will be measured in tissues of healthy volunteers. | Baseline up to 10 days |
| Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Standard Deviation from Baseline of Immune Cell Populations Within a Participant | Change in standard deviation from baseline of immune cell populations within a participant will be measured. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| C527606 | smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic |
| D004731 | Endotoxins |
| D015002 | Yeast, Dried |
| ID | Term |
|---|---|
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D019587 | Dietary Supplements |
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| Shingrix | Biological | Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection. |
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| LPS | Biological | LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection. |
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| Candin | Biological | Candin 0.1 mL solution for injection will be administered as one intradermal injection. |
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| Skin Biopsy | Other | 3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1. |
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| Saline Control | Other | Saline control solution for injection will be administered as one intradermal injection. |
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Soluble cytokines and chemokines will be measured by immunoassay. |
| Baseline up to 90 days |
| Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines) | Soluble cytokines and chemokines will be measured by immunoassay. | Baseline up to 14 days |
| Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines) | Soluble cytokines and chemokines will be measured by immunoassay. | Baseline up to 10 days |
| Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins) | Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry. | Baseline up to 90 days |
| Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins) | Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry. | Baseline up to 14 days |
| Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins) | Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry. | Baseline up to 10 days |
| Cohort 1 and Cohort 2: Change from Baseline in Expression of Inflammatory Mediators | Transcriptional changes in gene expression will be measured by established methods such as ribonucleic acid (RNA) microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell. | Baseline up to 90 days |
| Cohort 3 and Cohort 4: Change from Baseline in Expression of Inflammatory Mediators | Transcriptional changes in gene expression will be measured by established methods such as ribonucleic acid (RNA) microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell. | Baseline up to 14 days |
| Cohort 5: Change from Baseline in Expression of Inflammatory Mediators | Transcriptional changes in gene expression will be measured by established methods such as RNA microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell. | Baseline up to 10 days |
| Change in Standard Deviation from Baseline of Immune Cell Populations Between Participants |
Change in standard deviation from baseline of immune cell populations between participants will be measured. |
| Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days |
| Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Within a Participant | Change in standard deviation from baseline in cell surface antigen phenotype within a participant will be measured. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days |
| Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Between Participants | Change in standard deviation from baseline in cell surface antigen phenotype between participants will be measured. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days |
| Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Within a Participant | Change in standard deviation from baseline in activation status of inflammatory mediators within a participant will be measured. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days |
| Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Between Participants | Change in standard deviation from baseline in activation status of inflammatory mediators between participants will be measured. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days |
| Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Within a Participant | Change in standard deviation from baseline in expression of inflammatory mediators within a participant will be measured. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days |
| Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Between Participants | Change in standard deviation from baseline in expression of inflammatory mediators between participants will be measured. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days |
| Correlation of Baseline Immune Cell Populations with Vaccine/Antigen Immune Response Phenotype | Correlation of baseline immune cell populations with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days |
| Correlation of Genomics with Vaccine/Antigen Immune Response Phenotype | Correlation of genomics with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days |
| Correlation of Serology with Vaccine/Antigen Immune Response Phenotype | Correlation of serology with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days |
| Correlation of Soluble Proteins with Vaccine/Antigen Immune Response Phenotype | Correlation of soluble proteins with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays. | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days |
| D005502 |
| Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |