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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: PPSV23; Drug: Nipocalimab; Biological: Tdap

Study type: Interventional

Funder types: Industry

Identifiers

NCT05827874

80202135EDI1009 (Other Identifier)

CR109301

2022-003131-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Active Arm:

Experimental group

Description:

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.

Treatment:

Biological: Tdap

Drug: Nipocalimab

Biological: PPSV23

Control Arm:

Other group

Description:

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

Treatment:

Biological: Tdap

Biological: PPSV23