A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants

Abstract

Nipocalimab, a human immunoglobulin G (IgG) 1 monoclonal antibody, selectively binds the IgG-binding site on the neonatal Fc receptor (FcRn) and blocks IgG recycling, reducing IgG levels without impacting antigen presentation or T-/B-cell functions. In this phase 1, open-label study, we assessed the effect of nipocalimab on IgG response in healthy adults receiving T-cell-dependent/-independent vaccines (ie, tetanus toxoid [TT], diphtheria, and acellular pertussis vaccine [Tdap] and 23-polysaccharide pneumococcal vaccine [PPSV®23], respectively). Participants received either no drug (control) or intravenous nipocalimab (30 mg/kg at Week 0; 15 mg/kg at Weeks 2 and 4). All participants received Tdap and PPSV®23 vaccinations on Day 3 and were followed through Week 16. Twenty-nine participants completed the study (active, n=15; control, n=14). All participants mounted a response to Tdap vaccination, with 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). Nipocalimab treatment was associated with numerically lower anti-TT and anti-pneumococcal (PCP)-specific IgG responses at Week 4 but comparable responses at Weeks 2 and 16. Overall, anti-TT IgG levels remained above the protective threshold (0.16 IU/mL) for all participants, and anti-PCP IgG levels remained above the 50 mg/L threshold and showed a 2-fold increase from baseline in both arms. Nipocalimab coadministration with Tdap and PPSV®23 was safe and well tolerated. Results suggest that nipocalimab does not impact the development of IgG responses to T-cell-dependent/-independent vaccines and participants treated with nipocalimab can follow recommended vaccination schedules.Trial registration number: NCT05827874.

Keywords: T cell–dependent; T cell–independent; immunoglobulin G; nipocalimab; vaccine.

Figure 1.

Median (IQR) serum nipocalimab concentrations over time in the PK analysis set^a,b.

Figure 2.

Total IgG (a) percent change from baseline and (b) levels over time in the completers analysis set.

Figure 3.

Anti-TT IgG (a) percent change from baseline and (b) levels over time in the completers analysis set.

Figure 4.

Total anti-PCP IgG (a) percent change from baseline and (b) levels over time in the completers analysis set.

Figure 5.

Serotype-specific anti-PCP IgG response at (a) Week 4 and (b) Week 16 in the completers analysis set^a.