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

NCT03953196 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: CR108590NOPRODNAP0016
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (12)

• 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 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 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 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 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

Study Arms (5)

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.

Biological: Imvanex

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.

Biological: Shingrix

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.

Biological: LPS

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.

Biological: Candin; Other: Saline Control

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.

Other: Skin Biopsy

Interventions

Imvanex BIOLOGICAL

Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.

Also known as: Imvamune

Cohort 1: Vaccine Challenge Imvanex

Shingrix BIOLOGICAL

Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.

Cohort 2: Vaccine Challenge Shingrix

LPS BIOLOGICAL

LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.

Also known as: Endotoxin

Cohort 3: Antigen Challenge Lipopolysaccharides (LPS)

Candin BIOLOGICAL

Candin 0.1 mL solution for injection will be administered as one intradermal injection.

Also known as: Candida albicans

Cohort 4: Antigen Challenge Candin

Skin Biopsy OTHER

3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.

Cohort 5: Skin Wounding Challenge

Saline Control OTHER

Saline control solution for injection will be administered as one intradermal injection.

Cohort 4: Antigen Challenge Candin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic; Endotoxins; Yeast, Dried

Intervention Hierarchy (Ancestors)

Bacterial Toxins; Toxins, Biological; Biological Factors; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: May 16, 2019
• Study Start: April 8, 2019
• Primary Completion: December 26, 2019
• Study Completion: December 26, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)