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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.
Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.
LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.
Clinical Pharmacology Unit
Merksem, Belgium
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 10 days
Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
Soluble cytokines and chemokines will be measured by immunoassay.
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Candin 0.1 mL solution for injection will be administered as one intradermal injection.
3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.
Saline control solution for injection will be administered as one intradermal injection.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 10 days
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.
Time frame: 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 of Immune Cell Populations Between Participants
Change in standard deviation from baseline of immune cell populations between participants will be measured.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days