NCT07242092

Brief Summary

This clinical trial aims to evaluate the effect of temporary methotrexate (MTX) discontinuation on the humoral immunogenicity of the 20-valent pneumococcal conjugate vaccine (PCV20) in adult patients with autoimmune rheumatic diseases (ARDs). Key questions:

  • Does suspending MTX for 2 weeks after PCV20 enhance humoral immunogenicity?
  • What is the impact of MTX discontinuation on functional opsonophagocytic activity (OPA) and cellular immunity?
  • What is the risk of disease flaring with MTX withdrawal?

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for phase_4

Timeline
33mo left

Started Mar 2026

Typical duration for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

September 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

March 24, 2026

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

September 19, 2025

Last Update Submit

March 19, 2026

Conditions

Autoimmune Rheumatic Diseases

Keywords

Pneumococcal VaccineMethotrexatePCV20ImmunogenicityVaccinationRheumatology

Outcome Measures

Primary Outcomes (1)

  • Seroconversion Rate After Vaccination

    Proportion of participants who achieve seroconversion, defined as at least a twofold increase in IgG antibody concentrations for ≥50% of PCV20 vaccine serotypes (1, 3, 4, 5, 6B, 7F, 8, 9V, 12F, 14, 19A e 23F) compared to baseline, measured by multiplex Luminex assay.

    Day 28 (4 weeks post-vaccination).

Secondary Outcomes (11)

  • Opsonophagocytic Activity (OPA) Response

    Day 0 to Day 28

  • Persistence of Humoral Immunity

    Day 180 (6 months post-vaccination).

  • Frequency of Disease Flares in Rheumatoid Arthritis

    Baseline through Day 28.

  • Frequency of Disease Flares in Spondyloarthritis

    Baseline through Day 28

  • Frequency of Disease Flare in Systemic Lupus Erythematosus

    Baseline through Day 28

  • +6 more secondary outcomes

Study Arms (2)

MTX suspension

EXPERIMENTAL

Participants randomized to this arm will receive one dose of the 20-valent pneumococcal conjugate vaccine (PCV20) at baseline (D0). They will be instructed to discontinue methotrexate (MTX) for 2 weeks following vaccination, then resume their regular MTX regimen. Prednisone up to 5 mg/day and other stable background therapies will be maintained. Blood samples will be collected at baseline (D0), 4 weeks post-vaccination (D28), and 6 months post-vaccination (D180).

Biological: Pneumococcal Vaccine

MTX

ACTIVE COMPARATOR

Participants randomized to this arm will receive one dose of the 20-valent pneumococcal conjugate vaccine (PCV20) at baseline (D0). They will continue MTX therapy without interruption during the vaccination period, maintaining their stable immunosuppressive regimen. Prednisone up to 5 mg/day and other stable background therapies will also be maintained. Blood samples will be collected at baseline (D0), 4 weeks post-vaccination (D28), and 6 months post-vaccination (D180).

Biological: Pneumococcal Vaccine

Interventions

Pneumococcal VaccineBIOLOGICAL

All participants will receive a single intramuscular dose (0.5 mL) of PCV20 (Prevnar 20®, Pfizer), administered into the deltoid muscle at baseline (Day 0). PCV20 contains purified capsular polysaccharides of 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F), individually conjugated to the nontoxic diphtheria CRM197 carrier protein. The conjugation induces a T-cell dependent immune response, resulting in higher-affinity antibodies and immune memory compared to polysaccharide vaccines.

Also known as: 20-valent Pneumococcal Conjugate Vaccine (PCV20)
MTXMTX suspension

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (\>=18 years ) with confirmed ARD diagnosis (e.g., RA, PsA, axial SpA, primary Sjögren's, SLE, IIM, SSc, MCTD).
  • Stable MTX dose ≥12 weeks.
  • Prednisone ≤5 mg/day.
  • Low disease activity/remission according to specific disease activity criteria.
  • Eligible for PCV20 vaccination (no prior PCV20).

You may not qualify if:

  • Anaphylaxis to vaccine components.
  • Acute febrile illness.
  • Guillain-Barré, decompensated CHF (NYHA III-IV), demyelinating disease.
  • Live virus vaccine ≤4 weeks or inactivated vaccine ≤2 weeks before.
  • Blood products in last 6 months.
  • Severe infection in last month (including pneumococcal).
  • Hospitalization at enrollment.
  • Refusal to participate or inability to complete study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmole-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.

    PMID: 22739693BACKGROUND

  • Chapman TJ, Pichichero ME, Kaur R. Comparison of pneumococcal conjugate vaccine (PCV-13) cellular immune responses after primary and booster doses of vaccine. Hum Vaccin Immunother. 2020 Dec 1;16(12):3201-3207. doi: 10.1080/21645515.2020.1753438. Epub 2020 May 13.

    PMID: 32401658BACKGROUND

  • Ribeiro AC, Guedes LK, Moraes JC, Saad CG, Aikawa NE, Calich AL, Franca IL, Carvalho JF, Sampaio-Barros PD, Goncalves CR, Borba EF, Timenetsky Mdo C, Precioso AR, Duarte A, Bonfa E, Laurindo IM. Reduced seroprotection after pandemic H1N1 influenza adjuvant-free vaccination in patients with rheumatoid arthritis: implications for clinical practice. Ann Rheum Dis. 2011 Dec;70(12):2144-7. doi: 10.1136/ard.2011.152983. Epub 2011 Aug 22.

    PMID: 21859696BACKGROUND

  • ten Wolde S, Breedveld FC, Hermans J, Vandenbroucke JP, van de Laar MA, Markusse HM, Janssen M, van den Brink HR, Dijkmans BA. Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis. Lancet. 1996 Feb 10;347(8998):347-52. doi: 10.1016/s0140-6736(96)90535-8.

    PMID: 8598699BACKGROUND

MeSH Terms

Interventions

Pneumococcal Vaccines

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

Clovis A Silva, Full Professor

CONTACT

(11) 2661-6105vacina.reumatousp@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2025

First Posted

November 21, 2025

Study Start

March 25, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2028

Last Updated

March 24, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share