CRS Clinical Research Services Berlin GmbH
Berlin, 13627, Germany
NCT Number: NCT05827874
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Berlin, 13627, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nipocalimab will be administered as an IV infusion.
Other names: JNJ-80202135
Tdap will be administered as an IM injection.
Other names: GSK Boostrix
PPSV23 will be administered as an IM injection.
Other names: MSD Pneumovax23
Time frame: 4 Weeks post-vaccination at Week 0 (Up to Week 4)
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.
Time frame: Baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)
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.
Time frame: Change from baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)
Change from baseline in anti-PCP IgG levels over time through 16 Weeks post-vaccination will be reported.
Time frame: Up to 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.
Time frame: Up to 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.
Time frame: Up to 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]).
Time frame: Pre dose, 1, 24, 48, 72 hours at Week 0 and Week 2, 4, 8 and 16 post dose
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.
Time frame: Up to Week 16
Number of participants with ADAs to nipocalimab will be reported.
Time frame: Up to Week 16
Changes in total IgG and its subclasses (IgG1, IgG2, IgG3, IgG4) serum levels over time will be reported.
Janssen Research & Development, LLC
Industry
A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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