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

NCT03953196 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-02-03

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Imvanex

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

BIOLOGICAL

Shingrix

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

BIOLOGICAL

LPS

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

BIOLOGICAL

Candin

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

OTHER

Skin Biopsy

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

OTHER

Saline Control

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2019-12-26
Completion
2019-12-26
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03953196 on ClinicalTrials.gov