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

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ClinicalTrials.gov Identifier: NCT03953196
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to characterize the immune response in vivo using approved vaccines and antigen challenges to stimulate the immune system.

Condition or disease Intervention/treatment Phase
Healthy Biological: Imvanex Biological: Shingrix Biological: LPS Biological: Candin Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 0 Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Volunteers
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : September 3, 2019
Estimated Study Completion Date : September 3, 2019

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 Name: 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 Name: Endotoxin

Experimental: Cohort 4: Antigen Challenge Candin
Participants will receive one injection of Candin 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 Name: Candida albicans




Primary Outcome Measures :
  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 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Secondary Outcome Measures :
  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953196


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Belgium
Clinical Pharmacology Unit Recruiting
Merksem, Belgium, 2170
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03953196     History of Changes
Other Study ID Numbers: CR108590
NOPRODNAP0016 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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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

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs