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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003131-26 | EudraCT Number | ||
| 80202135EDI1009 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Arm: | Other | Participants will receive PPSV23 and Tdap vaccine challenge as an IM injection on Day 3 of Week 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipocalimab | Drug | Nipocalimab will be administered as an IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Positive IgG Response to TT Vaccine from Baseline through 16 Weeks Post-vaccination | Percentage of participants with positive IgG response to TT vaccine from baseline through 16 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13627 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40232701 | Derived | 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. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
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| Tdap | Biological | Tdap will be administered as an IM injection. |
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| PPSV23 | Biological | PPSV23 will be administered as an IM injection. |
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| 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 in anti-PCP IgG levels over time through 16 Weeks post-vaccination will be reported. | 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 | Percentage of participants with TEAEs through Week 16 will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Week 16 |
| Percentage of Participants with Serious Adverse Events (SAEs) Through Week 16 | Percentage of Participants with SAEs through Week 16 will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above. | Up to Week 16 |
| Percentage of Participants with Adverse Events of Special Interests (AESIs) Through Week 16 | Percentage of participants with AESIs through Week 16 will be reported. Treatment-emergent AEs associated with the following situations are considered an AESI: a) infections that are severe or require intravenous (IV) anti-infective or operative/invasive intervention; b) hypoalbuminemia with albumin less than (<)20 grams per liter (g/L) [<] 2.0 grams per deciliter [g/dL]). | Up to Week 16 |
| Serum Concentrations of Nipocalimab Over Time | Serum concentrations of nipocalimab over time will be reported. Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method. | Pre dose, 1, 24, 48, 72 hours at Week 0 and Week 2, 4, 8 and 16 post dose |
| Number of Participants with Anti-Drug Antibodies (ADAs) to Nipocalimab | Number of participants with ADAs to nipocalimab will be reported. | Up to Week 16 |
| Changes in Total IgG and its Subclasses (IgG1, IgG2, IgG3, IgG4) Serum Levels Over Time | Changes in total IgG and its subclasses (IgG1, IgG2, IgG3, IgG4) serum levels over time will be reported. | Up to Week 16 |