AzTrials
AzTrials

Autoimmune Rheumatologic DiseasePhase 4PCV20-PARDNCT07252791

Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases

A Phase 4 study testing Pneumococcal Vaccine in people with Autoimmune Rheumatologic Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This clinical trial evaluates the immunogenicity (humoral and cellular) and safety of the 20-valent pneumococcal conjugate vaccine (PCV20) in children, adolescents, and young adults aged 2-25 years with autoimmune rheumatic diseases (ARDs). All participants will receive PCV20 according to prior vaccine history. Read more about this study

Who is it for?
Ages 2 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Autoimmune Rheumatologic Disease
What is being tested?
Pneumococcal Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteBrazil
Study dates
16 Jan 2026to 30 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 2 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Age 2-25 years
  • Diagnosis of JIA, jSLE, or JDM by validated classification criteria
  • Clinically stable
  • Informed consent/assent

Who cannot join

  • Acute infection or fever at vaccination
  • Severe allergic reaction to vaccine components
  • Recent blood transfusion (<6 months)
  • Other vaccine within 4 weeks prior at the time of inclusion
  • Pregnancy or breastfeeding
  • Prior PCV20

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clovis A Silva, Full Professor contact

(11) 2661-6105

reumatologia.fmusp@hc.fm.usp.br

Brazil1 site, 1 recruiting

  • Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo

    Luisa Forero, MD, 1130617490 ext. +55, luisa.forero@hc.fm.usp.br

    Recruiting

Other trials in Brazil

About this study

Official title: Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases

This clinical trial evaluates the immunogenicity (humoral and cellular) and safety of the 20-valent pneumococcal conjugate vaccine (PCV20) in children, adolescents, and young adults aged 2-25 years with autoimmune rheumatic diseases (ARDs). All participants will receive PCV20 according to prior vaccine history. Antibody titers, opsonophagocytic activity, cellular immune responses, and adverse events will be measured up to 6 months post-vaccination. Effects of immunosuppressive therapy and physical activity levels related vaccine response will also be assessed.

Read the detailed description

ARD patients are at higher risk of pneumococcal infections due to disease-related and therapy-induced immunosuppression. Despite vaccination recommendations, immunogenicity data for PCV20 in ARD pediatric populations are lacking. This prospective phase IV study will enroll 85 patients aged 2-25 years diagnosed with juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (jSLE), and juvenile dermatomyositis (JDM). All will receive PCV20 per CDC guidance. Blood samples will be collected at baseline (D0), 4 weeks (D28), and 6 months (D180). The functional opsonophagocytic activity (OPA) for specific serotypes will be analyzed. Safety will be monitored through adverse event diaries, clinical evaluations, and disease activity indices. Physical activity will be evaluated by validated questionnaires and via accelerometry.

Being tested
Pneumococcal Vaccine
Keywords
Pneumococcal Conjugate Vaccine, PCV20, Autoimmune Diseases, Pediatric Rheumatology, Immunogenicity, Vaccine Safety
Medical subject headings
Autoimmune Diseases

What participants receive

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

  • Pneumococcal VaccineBiological

    Also called 20-valent pneumococcal conjugate vaccine

    0.5 mL intramuscular dose containing polysaccharide conjugates for 20 pneumococcal serotypes (PCV20, Prevenar 20) vaccine will be administered intramuscularly in 1 dose in patients with ARDs and healthy controls.

Study groups in NCT07252791
Study groupRoleWhat they receive
ARDsExperimentalPCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
Receives: Biological: Pneumococcal Vaccine
Healthy controlActive comparatorPCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
Receives: Biological: Pneumococcal Vaccine

What is being measured

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

  1. Seroconversion Rate After Vaccination

    Will be defined as ≥2-fold increase in IgG titers for ≥50% of serotypes.

    Measured: Day 0 to Day 28 and through 180 days

Secondary outcomes (8)

  1. Opsonophagocytic Antibody Titers (OPA)

    Blood samples will be collected at three time points: before the first dose (D0), 4 weeks after the first dose (D28), and six months after the final dose (D180). Functional opsonophagocytic anticapsular antibodies will be quantified using 6 validated serotype-specific opsonophagocytic activity (OPA) assays. Results will be expressed as geometric mean titers (GMTs) for each serotype and the percentage of participants reaching titers equal to or above the lower limit of quantification (LLOQ).

    Measured: Day 0 to Day 28 and through 180 days

  2. Safety Assessment

    Safety will be closely monitored, and all serious adverse events will be classified as related or unrelated to the vaccine. A standardized adverse event diary will be provided to all patients and healthy controls for recording local and systemic reactions during the 4 weeks after first dose. Local reactions include: injection site pain, redness, swelling, bruising, itching, and induration. Systemic reactions include: fever, fatigue, chills, malaise, drowsiness, loss of appetite, nausea, vomiting, diarrhea, abdominal pain, dizziness, tremors, headache, fatigue, myalgia, muscle weakness, arthralgia, pruritus, and skin rash.

    Measured: Day 1 through Day 28

  3. Impact of PCV20 vaccination on Disease Activity on patients with JIA

    To evaluate the impact of PCV20 vaccination on clinical disease activity in patients with JIA, measured using JADAS27, higher scores indicate greater disease activity.

    Unit of Measure: Score (0-57)

    Measured: Day 1 through Day 28

  4. Impact of PCV20 vaccination on Disease Activity on patients with JSLE

    To evaluate the impact of PCV20 vaccination on clinical and laboratory disease activity in patients with juvenile systemic lupus erythematosus (jSLE), assessed using the SLEDAI-2K. The score incorporates clinical and laboratory manifestations of lupus, with higher scores indicating greater disease activity.

    Unit of Measure: Score (range 0-105)

    Measured: Day 1 through Day 28

  5. Impact of PCV20 vaccination on Disease Activity on patients with JDM

    To evaluate the impact of PCV20 vaccination on clinical and laboratory disease activity in patients with juvenile dermatomyositis (JDM), assessed using the Childhood Myositis Assessment Scale (CMAS). The CMAS evaluates muscle function and endurance, with higher scores indicating better muscle strength and physical performance.

    Unit of Measure: Score (range 0-52)

    Measured: Day 1 through Day 28

  6. Influence of Immunosuppressive Treatment

    To assess the short- and long-term influence of immunosuppressive treatment on the response to PCV-20 vaccination in patients with ARDs compared to healthy controls.

    Measured: Day 0 to Day 180

  7. Seroconversion Rates after PCV20 vaccination by Physical Activity Classification

    Proportion of participants who achieve seroconversion defined as at least a twofold increase in pneumococcal serotype-specific IgG antibody concentrations compared to baseline at Days 28 and 180 following PCV20 vaccination.

    Participants will be categorized as physically active or inactive based on World Health Organization criteria using validated methods.

    Measured: Day 1 to 180 post-vaccination

  8. Geometric Mean Titers of Pneumococcal Antibodies after PCV20 Vaccination by Physical Activity Classification

    Geometric mean titers of pneumococcal serotype-specific IgG antibodies will be quantified using multiplex Luminex assay at Days 28 and 180 after PCV20 vaccination.

    Participants will be classified as physically active or inactive according to the World Health Organization criteria, based on validated methods.

    Measured: Day 1 to 180 post-vaccination

Timeline

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

  1. First posted28 Nov 2025
  2. Study start16 Jan 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

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 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07252791
Sponsor's protocol ID
75531023.0.0000.0068
Acronym
PCV20-PARD
Status last verified
Nov 2025
First submitted
20 Aug 2025
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kobayashi M, Bennett NM, Gierke R, Almendares O, Moore MR, Whitney CG, Pilishvili T. Intervals Between PCV13 and PPSV23 Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2015 Sep 4;64(34):944-7. doi: 10.15585/mmwr.mm6434a4.

    PubMed 26334788

  • Jensen L, Christensen AE, Nielsen S, Pedersen FK, Rosthoj S, Jorgensen CS, Poulsen A. Response to pneumococcal conjugate and polysaccharide vaccination in children with rheumatic disease. Scand J Immunol. 2022 Feb;95(2):e13118. doi: 10.1111/sji.13118. Epub 2021 Nov 22.

    PubMed 34768311

  • Aikawa NE, Franca IL, Ribeiro AC, Sallum AM, Bonfa E, Silva CA. Short and long-term immunogenicity and safety following the 23-valent polysaccharide pneumococcal vaccine in juvenile idiopathic arthritis patients under conventional DMARDs with or without anti-TNF therapy. Vaccine. 2015 Jan 29;33(5):604-9. doi: 10.1016/j.vaccine.2014.12.030. Epub 2014 Dec 29.

    PubMed 25554240

  • Aikawa NE, Campos LM, Goldenstein-Schainberg C, Saad CG, Ribeiro AC, Bueno C, Precioso AR, Timenetsky Mdo C, Silva CA, Bonfa E. Effective seroconversion and safety following the pandemic influenza vaccination (anti-H1N1) in patients with juvenile idiopathic arthritis. Scand J Rheumatol. 2013;42(1):34-40. doi: 10.3109/03009742.2012.709272. Epub 2012 Sep 20.

    PubMed 22992045

  • Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.

    PubMed 22089462

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pneumococcal Vaccine in people with Autoimmune Rheumatologic Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Clovis A Silva, Full Professor ((11) 2661-6105, reumatologia.fmusp@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion Rate After Vaccination (time frame: Day 0 to Day 28 and through 180 days). 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 NCT07252791, which also lists 5 linked publications.

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 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in