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

January 31, 2025 updated by: Janssen Research & Development, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cohort 1 and Cohort 2: Change from Baseline of Immune Cell Populations
Time Frame: Baseline up to 90 days
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
Time Frame: Baseline up to 14 days
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
Time Frame: Baseline up to 10 days
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
Time Frame: 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.
Baseline up to 90 days
Cohort 3 and Cohort 4: Change from Baseline in Cell Surface Antigen Phenotype
Time Frame: 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.
Baseline up to 14 days
Cohort 5: Change from Baseline in Cell Surface Antigen Phenotype
Time Frame: Baseline up to 10 days
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)
Time Frame: Baseline up to 90 days
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)
Time Frame: Baseline up to 14 days
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)
Time Frame: Baseline up to 10 days
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)
Time Frame: Baseline up to 90 days
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)
Time Frame: Baseline up to 14 days
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)
Time Frame: Baseline up to 10 days
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
Time Frame: 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.
Baseline up to 90 days
Cohort 3 and Cohort 4: Change from Baseline in Expression of Inflammatory Mediators
Time Frame: 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.
Baseline up to 14 days
Cohort 5: Change from Baseline in Expression of Inflammatory Mediators
Time Frame: 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.
Baseline up to 10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Standard Deviation from Baseline of Immune Cell Populations Within a Participant
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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