A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants
Status and phase
Completed
Early Phase 1
Conditions
Healthy
Treatments
Biological: Shingrix
Biological: Candin
Other: Saline Control
Other: Skin Biopsy
Biological: LPS
Biological: Imvanex
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
48 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Basic Science
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
48 participants in 5 patient groups
Cohort 1: Vaccine Challenge Imvanex
Experimental group
Description:
Participants will receive single dose of Imvanex subcutaneously on Day 1. Participants will also be included in the DREEM EEG substudy.
Treatment:
Biological: Imvanex
Cohort 2: Vaccine Challenge Shingrix
Experimental group
Description:
Participants will receive single dose of Shingrix intramuscularly on Day 1. Participants will also be included in the DREEM EEG substudy.
Treatment:
Biological: Shingrix
Cohort 3: Antigen Challenge Lipopolysaccharides (LPS)
Experimental group
Description:
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.
Treatment:
Biological: LPS
Cohort 4: Antigen Challenge Candin
Experimental group
Description:
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.
Treatment:
Other: Saline Control
Biological: Candin
Cohort 5: Skin Wounding Challenge
Experimental group
Description:
3 punch biopsies will be performed per standard dermatologic practice guidelines. Lower abdomen tissue biopsy specimens will be collected on Day 1.
Treatment:
Other: Skin Biopsy
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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