The Efficacy and Safety of Simultaneous Vaccination with Polysaccharide Conjugate Vaccines Against Pneumococcal (13-Valent Vaccine) and Haemophilus influenzae Type b Infections in Children with Juvenile Idiopathic Arthritis Without Systemic Manifestations: A Prospective Cohort Study
Abstract
:1. Introduction
2. Methods
2.1. Study Design and Patient Selection
- -
- Diagnosis of JIA according to the ILAR (International League of Associations for Rheumatology) criteria [18];
- -
- Non-systemic JIA categories: oligoarthritis (persistent and extended), polyarthritis (rheumatoid factor positive and negative), enthesitis-related arthritis, and psoriatic arthritis;
- -
- Age at the study inclusion 2–18 years;
- -
- Treatment with either non-biologic or biologic disease-modified anti-rheumatic drugs (DMARDs) or their combination;
- -
- No previous vaccination against pneumococcal and Hemophilus influenza type b infection, except scheduled vaccination of this infection in the first year of life according to the national vaccine schedule [18].
- -
- Any information on vaccine intolerance in the past;
- -
- JIA with systemic onset or undifferentiated arthritis;
- -
- Patients with ongoing acute infection illness or 4 weeks before the baseline.
2.2. Vaccination
2.3. The Assessments of the Study
- (i)
- Demography
- (ii)
- Clinical assessment of JIA
- (iii)
- Laboratory assessment of JIA activity
- (iv)
- Assessment of the vaccine-specific antibodies
- (v)
- The safety of vaccination
- (a)
- Vaccine-associated AE included any acute reactions (first 30 min after injections) and delayed reactions (fever, malaise, fatigue, and injection-site reactions).
- (b)
- Disease-associated AE mentioned any clinical and/or laboratory signs of JIA flare or that required any changes in the treatment.
- (c)
- Common AEs included any events that occurred in the six-month follow-up period, except the abovementioned AEs.
- (vi)
- Respiratory infection episode analysis
2.4. The Study Outcomes
- (i)
- Analysis of seroconversion
- (ii)
- Assessment of JIA-related outcomes during this study: active joints, joints with limited motion, morning stiffness duration, MDVAS, pVAS, CHAQ, S-100 protein, CRP, hs-CRP, and ESR.
- (iii)
- The frequency of respiratory illness episodes and antibiotic administration at the end of the study were determined.
- (iv)
- Any AE during the six-month follow-up period after the baseline: fever and injection site reactions.
2.5. Statistical Analysis
2.6. Ethics
3. Results
3.1. The Demography of the Patients
3.2. Vaccine Seroconversion
3.3. Analysis of the Predictors of the Vaccination Outcome
3.4. JIA Outcomes During Vaccination
3.5. The Frequency of Acute Infectious Events and the Use of Antibacterial Therapy
3.6. Assessment of the Adverse Events
3.6.1. Mild Adverse Events
3.6.2. Severe AE
4. Discussion
5. Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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JIA Features | Results, n = 371 (%) |
---|---|
Demography | |
Sex, female, n (%) | 234 (63) |
Age at baseline *, years ± SD | 10.9 ± 4.2 |
JIA category, n (%) | |
Extended oligoarthritis | 2 (0.5) |
Persistent oligoarthritis | 167 (45) |
Polyarthritis, RF-negative | 164 (44.2) |
Polyarthritis, RF-positive | 12 (3.2) |
Psoriatic arthritis | 2 (0.5) |
Enthesitis-related arthritis | 24 (6.5) |
Uveitis, n (%) | 67 (18) |
ENT diseases, n (%) | 119 (32) |
Treatment at baseline | |
NSAIDs, n (%) | 13 (3.5) |
Oral corticosteroids, n (%) | 3 (0.8) |
Methotrexate, n (%) | 136 (36.7) |
Cyclosporine A, n (%) | 27 (5.9) |
Sulfasalazine, n (%) | 8 (2.2) |
Leflunomide, n (%) | 7 (1.9) |
Mofetyl mycophenolate, n (%) | 1 (0.3) |
Biologic treatment * | 217 (58.5) |
Etanercept | 70 (18.9) |
Adalimumab | 26 (7.0) |
Tocilizumab | 6 (1.6) |
Etanercept + nbDMARD | 54 (14.0) |
Adalimumab + nbDMARD | 52 (14.0) |
Tocilizumab + nbDMARD | 9 (2.4) |
Parameters (n = 371) n (%)/Me (IQR) [Min; Max] | D1 | D22 | EOS | p1 | p2 | p3 | p Total |
---|---|---|---|---|---|---|---|
Anti-SP IgG titer, U/mL * | 44 (19; 74) [0–283] | 90 (52; 179) [0–304] | 83 (40; 162) [0–784] | 0.000001 | 0.000001 | 0.01 | 0.000001 |
Protective titer anti-SP IgG, n (%) 95% CI | 339 (91) [88; 94] | 359 (97) [95; 98] | 351 (95) [92; 97] | <0.001 | <0.001 | >0.05 | <0.001 |
Patients with a two-fold-increased anti-SP titer, n (%) [95% CI] | - | 168 (45) [40; 51] | 185 (50) [45; 52] | - | <0.001 | <0.001 | <0.001 |
Anti-Hib titer, U/mL, median (IQR) [min; max] | 1.2 (0.3; 4.0) [0.0; 66.3] | 4.0 (4.0; 4.0) [0; 35] | 4.0 (3.8; 4.0) [0.1; 35.0] | 0.000001 | 0.000001 | 0.00002 | 0.000001 |
Patients with a protective anti-HIb titer, n (%) [95% CI] | 200 (54) [49; 59] | 355 (96) [93; 97] | 346 (94) [90; 97] | <0.001 | <0.001 | <0.001 | <0.001 |
Patients with a two-fold-increased anti-HIb titer, n (%) [95% CI] | - | 209 (56) [51; 61] | 196 (53) [48; 58] | - | <0.001 | >0.05 | <0.001 |
S-100 U/mL (n.v. > 2.9), Me (IQR) [min; max] | 2.3 (1.3; 3.9) [0.0; 95.0] | 2.6 (1.4; 4.4) [0.0; 169.0] | 0.67 (0.3; 1.7) [0.0; 168.0] | 0.024 | 0.001 | 0.001 | 0.000001 |
hs-CRP, U/mL (n.v. > 8.2) Me (IQR) [min; max] | 0.6 (0.2; 1.6) [0.0; 61.5] | 0.7 (0.3; 1.9) [0.0; 69.0] | 0.78 (0.3; 2.0) [0.0; 41.3] | 0.001 | 0.179 | 0.182 | 0.001 |
Active joints, Me (IQR) [min; max] | 0.0 (0.0; 1.0) [0.0; 44.0] | 0.0 (0.0;0.25) [0.0; 36.0] | 0.0 (0.0; 0.0) [0.0; 28.0] | 0.002 | 0.000001 | 0.000001 | 0.000001 |
Joints with limited ROM, Me (IQR) [min; max] | 0.0 (0.0; 2.0) [0.0; 45.0] | 0.0 (0.0; 2.0) [0.0; 45.0] | 0.0 (0.0; 0.0) [0.0; 28.0] | 0.009 | 0.000001 | 0.000006 | 0.000001 |
Morning stiffness, min, Me (IQR) [min; max] | 0 (0; 0) [0; 360] | 0 (0; 6) [0; 180] | 0 (0; 0) [0; 180] | 0.000003 | 0.000001 | 0.000001 | 0.000001 |
MDVAS, mm, Me (IQR) [min; max] | 0 (0; 8) [0; 88] | 0 (0; 10) [0; 85] | 0 (0; 0) [0; 56] | 0.000003 | 0.0000001 | 0.0000001 | 0.000001 |
Patient/parent VAS, mm, Me (IQR) [min; max] | 0 (0; 10) [0; 90] | 0 (0; 10) [0; 88] | 0 (0; 0) [0; 66] | 0.000001 | 0.0000001 | 0.0000001 | 0.000001 |
CHAQ, points, Me (IQR) [min; max] | 0.0 (0.0;0.13) [0.0; 2.8] | 0.0 (0.0; 0.0) [0.0; 2.5] | 0.0 (0.0; 0.0) [0.0; 2.3] | 0.01 | 0.0000001 | 0.000001 | 0.000001 |
ESR, mm/hr (n.v = 0–20) Me (IQR) [min; max] | 3 (2; 8) [0; 67] | 4 (2; 6) [0; 50] | 3 (2; 6) [0; 53] | 0.003 | 0.026 | 0.473 | 0.016 |
CRP, mg/mL (n.v. < 5) Me (IQR) [min; max] | 1.0 (0.5; 1.2) [0.0; 74.1] | 1.0 (0.4; 1.1) [0.0; 105.1] | 0.7 (0.3; 1.3) [0.0; 40.2] | 0.024 | 0.0002 | 0.01 | 0.000001 |
Characteristic | Univariate | Multivariate | ||
---|---|---|---|---|
OR (95% CI) | p-Value | OR (95% CI) | p-Value | |
bDMARD before vaccination | ||||
did not receive bDMARD | — | — | ||
received bDMARD | 0.75 (0.27: 1.87) | 0.5 | 0.73 (0.23; 2.42) | 0.6 |
DMARD before vaccination | ||||
did not receive methotrexate | — | — | ||
methotrexate | 1.15 (0.42; 2.89) | 0.8 | 0.96 (0.30; 3.17) | >0.9 |
S-100 before vaccination | 0.98 (0.95; 1.04) | 0.4 | 0.98 (0.94; 1.03) | 0.2 |
CRP before vaccination | 1.03 (0.96; 1.21) | 0.6 | 0.97 (0.90; 1.11) | 0.5 |
Active joints | 1.02 (0.93; 1.26) | 0.8 | 1.19 (0.96; 1.61) | 0.2 |
CHAQ | 0.68 (0.31; 1.97) | 0.4 | 0.18 (0.04; 0.92) | 0.026 |
ESR | 1.16 (1.02; 1.43) | 0.072 | 1.21 (1.05; 1.50) | 0.041 |
Characteristic | Univariate | Multivariate | ||
---|---|---|---|---|
OR (95% CI) | p-Value | OR (95% CI) | p-Value | |
bDMARD before vaccination | ||||
did not receive bDMARD | — | — | ||
received bDMARD | 0.45 (0.16; 1.11) | 0.10 | 0.29 (0.10; 0.79) | 0.019 |
DMARD before vaccination | ||||
did not receive methotrexate | — | — | ||
methotrexate | 0.69 (0.24; 1.69) | 0.4 | 0.39 (0.13; 1.05) | 0.072 |
S-100 before vaccination | 1.11 (0.98; 1.37) | 0.2 | 1.08 (0.98; 1.33) | 0.3 |
CRP before vaccination | 1.02 (0.96; 1.15) | 0.7 | 1.02 (0.95; 1.16) | 0.6 |
Active joints | 0.97 (0.91; 1.06) | 0.3 | 0.91 (0.75; 1.06) | 0.2 |
CHAQ | 0.89 (0.39; 2.81) | 0.8 | 2.34 (0.46; 25.5) | 0.4 |
ESR | 1.0 (0.96; 1.07) | 0.9 | 1.0 (0.95; 1.07) | 0.9 |
Infection Burden Indicators, Me (IQR) [Min; Max] | 6 Months Prior to Vaccination | 6 Months After Vaccination | p-Value |
---|---|---|---|
Duration of ARI episode *, days | 9.0 (5.0; 10.0) | 2.0 (1.0; 3.0) | <0.001 |
[0.0; 19.0] | [0.0; 15.0] | ||
The number of ARI episodes per patient * | 4.0 (3.0; 5.0) | 2.0 (1.0; 2.0) | <0.001 |
[0.00; 9.00] | [0.0; 5.0] | ||
The number of courses of antibacterial drugs * | 2.0 (2.0; 3.0) | 1.0 (0.0; 1.0) | <0.001 |
[0.0; 6.0] | [0.0; 3.0] | ||
Patients without ARI, n (%) | 21 (5.7) | 62 (16.7) | <0.001 |
Patients did not require antibacterial drugs, n (%) | 40 (10.8) | 87 (23.5) | <0.001 |
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Alexeeva, E.; Dvoryakovskaya, T.; Fetisova, A.; Kriulin, I.; Krekhova, E.; Kabanova, A.; Labinov, V.; Labinova, E.; Kostik, M. The Efficacy and Safety of Simultaneous Vaccination with Polysaccharide Conjugate Vaccines Against Pneumococcal (13-Valent Vaccine) and Haemophilus influenzae Type b Infections in Children with Juvenile Idiopathic Arthritis Without Systemic Manifestations: A Prospective Cohort Study. Vaccines 2025, 13, 177. https://doi.org/10.3390/vaccines13020177
Alexeeva E, Dvoryakovskaya T, Fetisova A, Kriulin I, Krekhova E, Kabanova A, Labinov V, Labinova E, Kostik M. The Efficacy and Safety of Simultaneous Vaccination with Polysaccharide Conjugate Vaccines Against Pneumococcal (13-Valent Vaccine) and Haemophilus influenzae Type b Infections in Children with Juvenile Idiopathic Arthritis Without Systemic Manifestations: A Prospective Cohort Study. Vaccines. 2025; 13(2):177. https://doi.org/10.3390/vaccines13020177
Chicago/Turabian StyleAlexeeva, Ekaterina, Tatyana Dvoryakovskaya, Anna Fetisova, Ivan Kriulin, Elizaveta Krekhova, Anna Kabanova, Vladimir Labinov, Elizaveta Labinova, and Mikhail Kostik. 2025. "The Efficacy and Safety of Simultaneous Vaccination with Polysaccharide Conjugate Vaccines Against Pneumococcal (13-Valent Vaccine) and Haemophilus influenzae Type b Infections in Children with Juvenile Idiopathic Arthritis Without Systemic Manifestations: A Prospective Cohort Study" Vaccines 13, no. 2: 177. https://doi.org/10.3390/vaccines13020177
APA StyleAlexeeva, E., Dvoryakovskaya, T., Fetisova, A., Kriulin, I., Krekhova, E., Kabanova, A., Labinov, V., Labinova, E., & Kostik, M. (2025). The Efficacy and Safety of Simultaneous Vaccination with Polysaccharide Conjugate Vaccines Against Pneumococcal (13-Valent Vaccine) and Haemophilus influenzae Type b Infections in Children with Juvenile Idiopathic Arthritis Without Systemic Manifestations: A Prospective Cohort Study. Vaccines, 13(2), 177. https://doi.org/10.3390/vaccines13020177