Healthy
Conditions
Brief summary
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.
Interventions
BIOLOGICALImvanex
Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.
BIOLOGICALShingrix
Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.
BIOLOGICALLPS
LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.
BIOLOGICALCandin
Candin 0.1 mL solution for injection will be administered as one intradermal injection.
OTHERSkin Biopsy
3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.
OTHERSaline Control
Saline control solution for injection will be administered as one intradermal injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kilogram (kg) * Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (for Cohort 3) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator * Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator * Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * All women must have a negative highly sensitive serum (Beta-human chorionic gonadotropin \[Beta-hCG\]) pregnancy test at screening and a negative urine pregnancy test predose on Day 1
Exclusion criteria
* History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease * History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, bleeding disorders, rheumatologic, psychiatric, or metabolic disturbances, and atopic dermatitis * Known allergies, hypersensitivity, or intolerance to any of the interventions in this study or their excipients * History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food * Contraindications to the use of any of the study interventions per prescribing information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 5: Change from Baseline in Expression of Inflammatory Mediators | Baseline up to 10 days | 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. |
| Cohort 5: Change from Baseline of Immune Cell Populations | Baseline up to 10 days | Change from baseline in immune cell populations will be measured in tissues of healthy volunteers. |
| Cohort 1 and Cohort 2: Change from Baseline in Cell Surface Antigen Phenotype | Baseline up to 90 days | Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers. |
| Cohort 3 and Cohort 4: Change from Baseline in Cell Surface Antigen Phenotype | Baseline up to 14 days | Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers. |
| Cohort 5: Change from Baseline in Cell Surface Antigen Phenotype | Baseline up to 10 days | Change from baseline in cell surface antigen phenotype will be measured in tissues of healthy volunteers. |
| Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines) | Baseline up to 90 days | Soluble cytokines and chemokines will be measured by immunoassay. |
| Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines) | Baseline up to 14 days | Soluble cytokines and chemokines will be measured by immunoassay. |
| Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines) | Baseline up to 10 days | Soluble cytokines and chemokines will be measured by immunoassay. |
| Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins) | Baseline up to 90 days | Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry. |
| Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins) | Baseline up to 14 days | Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry. |
| Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins) | Baseline up to 10 days | Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry. |
| Cohort 1 and Cohort 2: Change from Baseline in Expression of Inflammatory Mediators | Baseline up to 90 days | 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. |
| Cohort 3 and Cohort 4: Change from Baseline in Expression of Inflammatory Mediators | Baseline up to 14 days | 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. |
| Cohort 1 and Cohort 2: Change from Baseline of Immune Cell Populations | Baseline up to 90 days | Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers. |
| Cohort 3 and Cohort 4: Change from Baseline of Immune Cell Populations | Baseline up to 14 days | Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Standard Deviation from Baseline of Immune Cell Populations Between Participants | 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 will be measured. |
| Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Within a Participant | 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 will be measured. |
| Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Between Participants | 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 will be measured. |
| Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Within a Participant | 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 will be measured. |
| Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Between Participants | 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 will be measured. |
| Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Within a Participant | 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 will be measured. |
| Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Between Participants | 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 will be measured. |
| Correlation of Baseline Immune Cell Populations with Vaccine/Antigen Immune Response Phenotype | Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days | Correlation of baseline immune cell populations with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays. |
| Correlation of Genomics with Vaccine/Antigen Immune Response Phenotype | 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 will be measured by phenotypic and functional assays. |
| Correlation of Serology with Vaccine/Antigen Immune Response Phenotype | 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 will be measured by phenotypic and functional assays. |
| Correlation of Soluble Proteins with Vaccine/Antigen Immune Response Phenotype | 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 will be measured by phenotypic and functional assays. |
| Change in Standard Deviation from Baseline of Immune Cell Populations Within a Participant | 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 within a participant will be measured. |
Countries
Belgium
Outcome results
None listed