Clinical trial NCT05827874: A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants
Official title: A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with a Positive Anti-tetanus toxoid Immunoglobulin G (Anti-TT IgG) Response at 4 Weeks Post-vaccination
timeFrame: 4 Weeks post-vaccination at Week 0 (Up to Week 4)
Secondary outcomes:
measure: Percentage of Participants with Positive IgG Response to TT Vaccine from Baseline through 16 Weeks Post-vaccination
timeFrame: Baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)
measure: Change from Baseline in Anti-Pneumococcal Capsular Polysaccharide (PCP) IgG Levels Over Time Through 16 Weeks Post-vaccination
timeFrame: Change from baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 16
timeFrame: Up to Week 16
measure: Percentage of Participants with Serious Adverse Events (SAEs) Through Week 16
timeFrame: Up to Week 16
measure: Percentage of Participants with Adverse Events of Special Interests (AESIs) Through Week 16
timeFrame: Up to Week 16
measure: Serum Concentrations of Nipocalimab Over Time
timeFrame: Pre dose, 1, 24, 48, 72 hours at Week 0 and Week 2, 4, 8 and 16 post dose
measure: Number of Participants with Anti-Drug Antibodies (ADAs) to Nipocalimab
timeFrame: Up to Week 16
measure: Changes in Total IgG and its Subclasses (IgG1, IgG2, IgG3, IgG4) Serum Levels Over Time
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: