A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Imvanex; Biological: Shingrix; Biological: Candin; Other: Skin Biopsy; Biological: LPS; Other: Saline Control

• Registration Number: NCT03953196
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-01
• Study Start: 2019-04-08
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Primary Completion: 2019-12-26
• Study Completion: 2019-12-26
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Vaccine Challenge Imvanex	Imvanex	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	Shingrix	Participants will receive single dose of Shingrix intramuscularly on Day 1. Participants will also be included in the DREEM EEG substudy.
Cohort 4: Antigen Challenge Candin	Saline Control	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 4: Antigen Challenge Candin	Candin	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	Skin Biopsy	3 punch biopsies will be performed per standard dermatologic practice guidelines. Lower abdomen tissue biopsy specimens will be collected on Day 1.
Cohort 3: Antigen Challenge Lipopolysaccharides (LPS)	LPS	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.

Primary Outcome Measures

Name	Time	Method
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 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.
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 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 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 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 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 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 Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)	Baseline up to 90 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 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.

Secondary Outcome Measures

Name	Time	Method
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.
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 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 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.
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.
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.
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.
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 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 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.
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.

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇧🇪 Merksem, Belgium