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OpenTrials
Completed

NCT Number: NCT03953196

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imvanex

Biological

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

Other names: Imvamune

Shingrix

Biological

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

LPS

Biological

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

Other names: Endotoxin

CANDIN

Biological

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

Other names: Candida albicans

Skin biopsy

Other

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

Saline Control

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 16, 2019
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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