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

Healthy Clinical Trial

Official title:

A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827874
• Other study ID #: CR109301
• Secondary ID: 2022-003131-2680
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2023
• Est. completion date: October 4, 2023

Study information

• Verified date: October 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 4, 2023
• Est. primary completion date: October 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Nipocalimab
Nipocalimab will be administered as an IV infusion.

Biological:
• Tdap
Tdap will be administered as an IM injection.
• PPSV23
PPSV23 will be administered as an IM injection.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Berlin GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants with Anti-Drug Antibodies (ADAs) to Nipocalimab	Number of participants with ADAs to nipocalimab will be reported.	Up to Week 16
Secondary	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