Clinical trial NCT03953196: A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants
Official title: A Phase 0 Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Cohort 1 and Cohort 2: Change from Baseline of Immune Cell Populations
timeFrame: Baseline up to 90 days
measure: Cohort 3 and Cohort 4: Change from Baseline of Immune Cell Populations
timeFrame: Baseline up to 14 days
measure: Cohort 5: Change from Baseline of Immune Cell Populations
timeFrame: Baseline up to 10 days
measure: Cohort 1 and Cohort 2: Change from Baseline in Cell Surface Antigen Phenotype
timeFrame: Baseline up to 90 days
measure: Cohort 3 and Cohort 4: Change from Baseline in Cell Surface Antigen Phenotype
timeFrame: Baseline up to 14 days
measure: Cohort 5: Change from Baseline in Cell Surface Antigen Phenotype
timeFrame: Baseline up to 10 days
measure: Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
timeFrame: Baseline up to 90 days
measure: Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
timeFrame: Baseline up to 14 days
measure: Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
timeFrame: Baseline up to 10 days
measure: Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
timeFrame: Baseline up to 90 days
measure: Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
timeFrame: Baseline up to 14 days
measure: Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
timeFrame: Baseline up to 10 days
measure: Cohort 1 and Cohort 2: Change from Baseline in Expression of Inflammatory Mediators
timeFrame: Baseline up to 90 days
measure: Cohort 3 and Cohort 4: Change from Baseline in Expression of Inflammatory Mediators
timeFrame: Baseline up to 14 days
measure: Cohort 5: Change from Baseline in Expression of Inflammatory Mediators
timeFrame: Baseline up to 10 days
Secondary outcomes:
measure: Change in Standard Deviation from Baseline of Immune Cell Populations Within a Participant
timeFrame: 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
measure: Change in Standard Deviation from Baseline of Immune Cell Populations Between Participants
timeFrame: 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
measure: Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Within a Participant
timeFrame: 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
measure: Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Between Participants
timeFrame: 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
measure: Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Within a Participant
timeFrame: 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
measure: Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Between Participants
timeFrame: 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
measure: Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Within a Participant
timeFrame: 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
measure: Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Between Participants
timeFrame: 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
measure: Correlation of Baseline Immune Cell Populations with Vaccine/Antigen Immune Response Phenotype
timeFrame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
measure: Correlation of Genomics with Vaccine/Antigen Immune Response Phenotype
timeFrame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
measure: Correlation of Serology with Vaccine/Antigen Immune Response Phenotype
timeFrame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
measure: Correlation of Soluble Proteins with Vaccine/Antigen Immune Response Phenotype
timeFrame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: