A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

Phase 1 Completed 32 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this study is to assess the effect of nipocalimab treatment on the antibody (a protein made in the body to response to a foreign substance) response following tetanus, diphtheria, pertussis (Tdap) vaccination in healthy participants at Week 4.

Timeline

Start: 2023-04-12
Primary completion: 2023-10-04
Completion: 2023-10-04

Outcome

Missed primary endpoint

paper 3 (20%) participants in the active arm and 7 (50%) participants in the control arm achieving a positive anti-TT response at Week 4 (primary endpoint; p=.089). PMID 40232701 ↗

Publications

Cossu M, Bobadilla Mendez C, Jackson A, Myshkin E, Liu G, Lam E, Beier UH, Weisel K, Scott B, Leu JH, Gao S, Dimitrova D. A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants. Hum Vaccin Immunother. 2025 Dec;21(1):2491269. doi: 10.1080/21645515.2025.2491269. Epub 2025 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nipocalimab	Monoclonal antibody	15 mg/kg	Intravenous
Background	PPSV23	Vaccine	—	Intramuscular
Background	Tdap	Unknown	—	Intramuscular

Indications

No indication recorded.