A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants
NCT ID: NCT03953196
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
48 participants
INTERVENTIONAL
2019-04-08
2019-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
Imvanex
Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.
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.
Shingrix
Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.
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.
LPS
LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.
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.
Candin
Candin 0.1 mL solution for injection will be administered as one intradermal injection.
Saline Control
Saline control solution for injection will be administered as one intradermal injection.
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.
Skin Biopsy
3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.
Interventions
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Imvanex
Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.
Shingrix
Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.
LPS
LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.
Candin
Candin 0.1 mL solution for injection will be administered as one intradermal injection.
Skin Biopsy
3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.
Saline Control
Saline control solution for injection will be administered as one intradermal injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Clinical Pharmacology Unit
Merksem, , Belgium
Countries
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Other Identifiers
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NOPRODNAP0016
Identifier Type: OTHER
Identifier Source: secondary_id
CR108590
Identifier Type: -
Identifier Source: org_study_id
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