A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Percentage of Participants with a Positive Anti-tetanus toxoid Immunoglobulin G (Anti-TT IgG) Response at 4 Weeks Post-vaccination
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Active Arm:
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.
Intervention: Nipocalimab (Drug)
Active Arm:
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.
Intervention: Tdap (Biological)
Active Arm:
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.
Intervention: PPSV23 (Biological)
Control Arm:
Participants will receive PPSV23 and Tdap vaccine challenge as an IM injection on Day 3 of Week 0.
Intervention: Tdap (Biological)
Control Arm:
Participants will receive PPSV23 and Tdap vaccine challenge as an IM injection on Day 3 of Week 0.
Intervention: PPSV23 (Biological)
Outcomes
Primary Outcomes
Percentage of Participants with a Positive Anti-tetanus toxoid Immunoglobulin G (Anti-TT IgG) Response at 4 Weeks Post-vaccination
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.
Secondary Outcomes
- Number of Participants with Anti-Drug Antibodies (ADAs) to Nipocalimab(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 through 16 Weeks post-vaccination at Week 0 (Up to Week 16))
- Serum Concentrations of Nipocalimab Over Time(Pre dose, 1, 24, 48, 72 hours at Week 0 and Week 2, 4, 8 and 16 post dose)
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 16(Up to Week 16)
- Percentage of Participants with Positive IgG Response to TT Vaccine from Baseline through 16 Weeks Post-vaccination(Baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16))
- Changes in Total IgG and its Subclasses (IgG1, IgG2, IgG3, IgG4) Serum Levels Over Time(Up to Week 16)
- Percentage of Participants with Serious Adverse Events (SAEs) Through Week 16(Up to Week 16)
- Percentage of Participants with Adverse Events of Special Interests (AESIs) Through Week 16(Up to Week 16)