Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03953196 | A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants | EARLY_PHASE1 | COMPLETED | 48 | — | — | Apr 8, 2019 | Dec 26, 2019 | Feb 3, 2025 | 1 | Belgium |
Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers.
Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers.
Change from baseline in immune cell populations will be measured in tissues of healthy volunteers.
Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers.
Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers.
Change from baseline in cell surface antigen phenotype will be measured in tissues of healthy volunteers.
Soluble cytokines and chemokines will be measured by immunoassay.
Soluble cytokines and chemokines will be measured by immunoassay.
Soluble cytokines and chemokines will be measured by immunoassay.
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
|---|---|---|
| Imvanex | BIOLOGICAL | Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection. |
| Shingrix | BIOLOGICAL | Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection. |
| LPS | BIOLOGICAL | LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection. |
| Candin | BIOLOGICAL | Candin 0.1 mL solution for injection will be administered as one intradermal injection. |
| Skin Biopsy | OTHER | 3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1. |
| Saline Control | OTHER | Saline control solution for injection will be administered as one intradermal injection. |
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 electrocardiogra...