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

NCT05827874 | Completed Phase 1

• 3 other identifiers: CR1093012022-003131-2680202135EDI1009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with a Positive Anti-tetanus toxoid Immunoglobulin G (Anti-TT IgG) Response at 4 Weeks Post-vaccination

  Percentage of participants with a positive anti-TT IgG response at 4 weeks post-vaccination will be reported. It is defined as pre-vaccination anti-TT IgG antibody titers are less than (\<) 0.16 international units per milliliter (IU/mL) and post-vaccination anti-TT IgG titers are greater than or equal to (\>=) 0.16 IU/mL, or pre-vaccination anti-TT IgG are \>= 0.16 IU/mL and there is at least a 2-fold increase in post-vaccination anti-TT IgG titers.

  4 Weeks post-vaccination at Week 0 (Up to Week 4)

Secondary Outcomes (8)

• Percentage of Participants with Positive IgG Response to TT Vaccine from Baseline through 16 Weeks Post-vaccination

  Baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)

• Change from Baseline in Anti-Pneumococcal Capsular Polysaccharide (PCP) IgG Levels Over Time Through 16 Weeks Post-vaccination

  Change from baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)

• Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 16

  Up to Week 16

• Percentage of Participants with Serious Adverse Events (SAEs) Through Week 16

  Up to Week 16

• Percentage of Participants with Adverse Events of Special Interests (AESIs) Through Week 16

  Up to Week 16

Study Arms (2)

Active Arm:

EXPERIMENTAL

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.

Drug: Nipocalimab; Biological: Tdap; Biological: PPSV23

Control Arm:

OTHER

Participants will receive PPSV23 and Tdap vaccine challenge as an IM injection on Day 3 of Week 0.

Biological: Tdap; Biological: PPSV23

Interventions

Nipocalimab DRUG

Nipocalimab will be administered as an IV infusion.

Also known as: JNJ-80202135

Active Arm:

Tdap BIOLOGICAL

Tdap will be administered as an IM injection.

Also known as: GSK Boostrix

Active Arm:; Control Arm:

PPSV23 BIOLOGICAL

PPSV23 will be administered as an IM injection.

Also known as: MSD Pneumovax23

Active Arm:; Control Arm:

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant, and this determination must be recorded in the participant's source documents and initialed by the investigator
• Healthy on the basis of clinical laboratory tests performed at screening (including immunoglobulin G \[IgG\]). If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• Participant agrees not to donate bone marrow, blood, and blood products from the study intervention administration until 3 months after receiving it
• Body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kilograms (kg)
• must be a nonsmoker (not smoked for at least 3 months prior to screening) and has not used nicotine-containing products (example, nicotine patch and vaping) for at least 3 months prior to screening
• Willing and able to adhere to the lifestyle restrictions specified in this protocol

You may not qualify if:

• History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbance
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study
• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
• Known allergies, hypersensitivity, or intolerance to pneumococcal polysaccharide vaccine (PPSV23) and tetanus, diphtheria, pertussis (Tdap) vaccines, nipocalimab, or any of their excipients
• Has a serum albumin level less than (\<) 30 grams per liter (g/L) at screening or Day -1
• Has a total IgG less than or equal to (\<=) 6 g/L at screening.
• Has received a tetanus (example, Tdap, Td) vaccine in the past \<= 5 years

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location

Related Publications (1)

• 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.

  PMID: 40232701 DERIVED

MeSH Terms

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 25, 2023
• Study Start: April 12, 2023
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)