NCT03953196

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

A Phase 0 Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-04-08
• Primary completion: 2019-12-26
• Completion: 2019-12-26
• First posted: 2019-05-16
• Last updated: 2025-02-03

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study