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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05827874
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered as an IV infusion.
  • Tdap — BIOLOGICAL
    Tdap will be administered as an IM injection.
  • PPSV23 — BIOLOGICAL
    PPSV23 will be administered as an IM injection.

Study Details

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.

Key Dates

Start date
Apr 12, 2023
Status verified
Mar 2025
Primary completion
Oct 4, 2023
Completion
Oct 4, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active Arm:
    Participants will receive Nipocalimab loading dose intravenous (IV) infusion at Week 0 followed by tetanus, diphtheria, pertussis (Tdap) and pneumococcal polysaccharide vaccine (PPSV23) vaccine challenge as an intramuscular (IM) injection on Day 3 of Week 0 and additional doses of Nipocalimab IV at Week 2 and 4.
  • Other: Control Arm:
    Participants will receive PPSV23 and Tdap vaccine challenge as an IM injection on Day 3 of Week 0.

Primary Outcome Measure

Percentage of Participants with a Positive Anti-tetanus toxoid Immunoglobulin G (Anti-TT IgG) Response at 4 Weeks Post-vaccination [ Time Frame: 4 Weeks post-vaccination at Week 0 (Up to Week 4) ]

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