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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953196
• Other study ID #: CR108590
• Secondary ID: NOPRODNAP0016
• Status: Completed
• Phase: Early Phase 1
• Start date: April 8, 2019
• Est. completion date: December 26, 2019

Study information

• Verified date: January 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 26, 2019
• Est. primary completion date: December 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Imvanex
Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.
• Shingrix
Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.
• LPS
LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.
• Candin
Candin 0.1 mL solution for injection will be administered as one intradermal injection.

Other:
• Skin Biopsy
3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.
• Saline Control
Saline control solution for injection will be administered as one intradermal injection.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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