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HealthyPhase 1NCT05827874

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

A Phase 1 study testing Nipocalimab, Tdap and PPSV23 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Nipocalimab, Tdap and PPSV23
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteGermany
Study dates
12 Apr 2023to 4 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • CRS Clinical Research Services Berlin GmbH

    Berlin, 13627

Other trials in Germany

About this study

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

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.

Conditions
Healthy
Being tested
Nipocalimab, Tdap, PPSV23

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NipocalimabDrug

    Also called JNJ-80202135

    Nipocalimab will be administered as an IV infusion.

  • TdapBiological

    Also called GSK Boostrix

    Tdap will be administered as an IM injection.

  • PPSV23Biological

    Also called MSD Pneumovax23

    PPSV23 will be administered as an IM injection.

Study groups in NCT05827874
Study groupRoleWhat they receive
Active Arm:ExperimentalParticipants 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.
Receives: Drug: Nipocalimab; Biological: Tdap; Biological: PPSV23
Control Arm:OtherParticipants will receive PPSV23 and Tdap vaccine challenge as an IM injection on Day 3 of Week 0.
Receives: Biological: Tdap; Biological: PPSV23

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 Weeks post-vaccination at Week 0 (Up to Week 4)

Secondary outcomes (8)

  1. 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.

    Measured: Baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)

  2. 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.

    Measured: Change from baseline through 16 Weeks post-vaccination at Week 0 (Up to Week 16)

  3. 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.

    Measured: Up to Week 16

  4. 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.

    Measured: Up to Week 16

  5. 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]).

    Measured: Up to Week 16

  6. 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.

    Measured: Pre dose, 1, 24, 48, 72 hours at Week 0 and Week 2, 4, 8 and 16 post dose

  7. Number of Participants with Anti-Drug Antibodies (ADAs) to Nipocalimab

    Number of participants with ADAs to nipocalimab will be reported.

    Measured: Up to Week 16

  8. 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.

    Measured: Up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start12 Apr 2023
  3. Primary completion4 Oct 2023
  4. Study completion4 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827874
Sponsor's protocol ID
CR109301
Other IDs
2022-003131-26, 80202135EDI1009
Status last verified
Mar 2025
First submitted
4 Apr 2023
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • Cossu M, Bobadilla Mendez C, Jackson A, Myshkin E, Liu G, Lam E, Beier UH, Weisel K, Scott B, Leu JH, Gao S, Dimitrova D. A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants. Hum Vaccin Immunother. 2025 Dec;21(1):2491269. doi: 10.1080/21645515.2025.2491269. Epub 2025 Apr 15.

    PubMed 40232701

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nipocalimab, Tdap and PPSV23 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827874, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.

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