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

A Phase 0 Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Volunteers

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Imvanex; Biological: Shingrix; Biological: LPS; Biological: Candin; Other: Saline Control; Other: Skin Biopsy

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Merksem, Belgium, 2170
    • Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Vaccine Challenge Imvanex; Participants will receive single dose of Imvanex subcutaneously on Day 1. Participants will also be included in the DREEM EEG substudy.	Biological: Imvanex; Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.; Other Names: Imvamune
Experimental: Cohort 2: Vaccine Challenge Shingrix; Participants will receive single dose of Shingrix intramuscularly on Day 1. Participants will also be included in the DREEM EEG substudy.	Biological: Shingrix; Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.
Experimental: Cohort 3: Antigen Challenge Lipopolysaccharides (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.	Biological: LPS; LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.; Other Names: Endotoxin
Experimental: Cohort 4: Antigen Challenge 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.	Biological: Candin; Candin 0.1 mL solution for injection will be administered as one intradermal injection.; Other Names: Candida albicans; Other: Saline Control; Saline control solution for injection will be administered as one intradermal injection.
Experimental: Cohort 5: Skin Wounding Challenge; 3 punch biopsies will be performed per standard dermatologic practice guidelines. Lower abdomen tissue biopsy specimens will be collected on Day 1.	Other: Skin Biopsy; 3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): December 26, 2019
• Study Completion (Actual): December 26, 2019

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CR108590; NOPRODNAP0016 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes