Hostname: page-component-cb9f654ff-qc88w Total loading time: 0 Render date: 2025-09-01T21:04:41.620Z Has data issue: false hasContentIssue false

P.100 A randomized, open-label study on the effect of Nipocalimab on vaccine responses in healthy participants

Published online by Cambridge University Press:  10 July 2025

M Cossu
Affiliation:
(Leiden)
C Bobadilla Mendez
Affiliation:
(Spring House)
A Jackson
Affiliation:
(La Jolla)
E Myshkin
Affiliation:
(Cambridge)
G Liu
Affiliation:
(Raritan)
E Lam
Affiliation:
(Spring House)
U Beier
Affiliation:
(Spring House)
K Weisel
Affiliation:
(Spring House)
B Scott
Affiliation:
(Spring House)
M Ait-Tihyaty
Affiliation:
(Spring House)
B Sattin
Affiliation:
(Toronto)*
J Leu
Affiliation:
(Spring House)
S Gao
Affiliation:
(Spring House)
D Dimitrova
Affiliation:
(Spring House)
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

Background: Nipocalimab is a human IgG1 monoclonal antibody targeting FcRn that selectively reduces IgG levels without impacting antigen presentation, T- and B-cell functions. This study describes the effect of nipocalimab on vaccine response. Methods: Open-label, parallel, interventional study randomized participants 1:1 to receive intravenous 30mg/kg nipocalimab at Week0 and 15mg/kg at Week2 and Week4 (active) or no drug (control). On Day 3, participants received Tdap and PPSV®23 vaccinations and were followed through Wk16. Results: Twenty-nine participants completed the study and are included (active, n=15; control, n=14). Participants with a positive anti-tetanus IgG response was comparable between groups at Wk2 and Wk16, but lower at Wk4 (nipocalimab 3/15 [20%] vs control 7/14 [50%]; P=0.089). All maintained anti-tetanus IgG above the protective threshold (0.16IU/mL) through Wk16. While anti-pneumococcal-capsular-polysaccharide (PCP) IgG levels were lower during nipocalimab treatment, the percent increase from baseline at Wk2 and Wk16 was comparable between groups. Post-vaccination, anti-PCP IgG remained above 50mg/L and showed a 2-fold increase from baseline throughout the study in both groups. Nipocalimab co-administration with vaccines was safe and well-tolerated. Conclusions: These findings suggest that nipocalimab does not impact the development of an adequate IgG response to T-cell–dependent/independent vaccines and that nipocalimab-treated patients can follow recommended vaccination schedules.

Information

Type
Abstracts
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of Canadian Neurological Sciences Federation