Efficacy and Safety of Anti-Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab in Neonates: A Real-World Monocentric Study
Abstract
1. Introduction
2. Materials and Methods
2.1. Population and Study Design
2.2. Data Collection and Endpoints
2.3. Statistical Analysis
3. Results
3.1. Safety Profile and Vaccinated Cohort Demographics
3.2. Season-Wide RSV Incidence
3.3. Within-Season Comparison
3.4. Clinical Outcomes by Season
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
RSV | Respiratory syncytial virus |
MoAbs | Monoclonal antibodies |
AEFI | Adverse Events Following Immunization |
NICU | Neonatal Intensive Care Unit |
PNCU | Physiological Neonatal Care Unit |
GDPR | General Data Protection Regulation |
GA | Gestational age |
CRF | Case report form |
AEFIs | Adverse events following immunization |
LBW | Low birth weight |
NBW | Normal birth weight |
HBW | High birth weight |
SAEFIs | Severe AEFIs |
SD | Standard deviation |
RR | Relative risks |
CI | Confidence interval |
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Characteristics | Total Cohort N = 491 | Preterm Newborns N = 73 | Term Newborns N = 418 | p Value |
---|---|---|---|---|
M/F, n (%) | 261 (53)/230 (47) | 40 (55)/33 (45) | 221 (53)/197 (47) | 0.8 |
Mean GA, weeks (range) | 38 ± 2.5 (23–43) | 34 ± 3.0 (23–36) | 39 ± 1.2 (37–43) | <0.01 |
LBW, n (%) | 64 (13) | 47 (64) | 17 (4) | <0.01 |
NBW, n (%) | 415 (85) | 26 (36) | 389 (93) | |
HBW, n (%) | 12 (2) | 0 (0) | 12 (3) | |
Mean weight at birth ± SD, g | 3078 ± 598 | 2158 ± 651 | 3238 ± 415 | <0.01 |
Mean LBW weight ± SD, g | 1950 ± 482 | 1786 ± 479 | 2339 ± 127 | <0.01 |
Mean NBW weight ± SD, g | 3223 ± 359 | 2832 ± 260 | 3249 ± 350 | <0.01 |
Mean HBW weight ± SD, g | 4158 ± 145 | - | 4158 ± 145 | - |
Season 1 (2024–2025) | Season 2 (2023–2024) | Season 3 (2022–2023) | Season 2 + 3 Combined | |
---|---|---|---|---|
Newborns, n | 582 | 744 | 709 | 1453 |
RSV infection, n | 3 | 12 | 5 | 17 |
Infection rate (95%CI) | 0.52 (0.11–1.53) | 1.61 (0.84–2.79) | 0.71 (0.23–1.64) | 1.17 (0.68–1.87) |
RR compared to 2024–2025 season * | - | 0.31 (0.09–1.13) | 1.41 (0.18–3.05) | 0.45 (0.13–1.50) |
Mid-P Fisher | - | 0.051 | 0.61 | 0.18 |
AEFI, n (%) | 0/491 (0) | - | - | - |
95% upper bound | 0–0.73 | - | - | - |
Comparison | Posterior Probability | Interpretation |
---|---|---|
2024–2025 vs. 2023–2024 | 0.97 | 97% chance that the 2024–2025 season had lower RSV rate |
2024–2025 vs. pooled 2022–2024 | 0.89 | 89% chance that the 2024–2025 season had lower RSV rate |
2024–2025 vs. 2023–2024, (2 cases vs. 12) | 0.99 | 99% chance that the 2024–2025 season had lower RSV rate under stricter analysis |
Group | Total Infants | RSV Cases (n) | Infection Rate (%) | RR * (95%CI) | Mid-P Fisher p-Value $ |
---|---|---|---|---|---|
Vaccinated | 490 | 2 | 0.41% | 0.38 (0.03–4.1) | 0.4 |
Unvaccinated | 92 | 1 | 1.09% | - | - |
2024–2025 (n = 3) | 2023–2024 (n = 12) | 2022–2023 (n = 5) | |
---|---|---|---|
Mean age at admission ± SD, days | 21 ± 3.6 | 19.3 ± 5.3 | 23.4 ± 5.8 |
Mean hospitalization time ± SD, days | 9.7 ± 0.6 | 8.3 ± 2.6 | 9.6 ± 5.4 |
Mean total ventilation support duration ± SD, days | 6.3 ± 0.6 | 6.0 ± 1.7 | 4.6 ± 1.8 |
Invasive ventilation, n (%) | 1 (33%) | 2 (17%) | 0 (0%) |
Mean duration if received, days | 0.83 ± 0.83 | 3.5 ± 0.7 | - |
Mean treatment duration ± SD, days | 5.7 ± 1.2 | 6.0 ± 1.7 | 6.4 ± 2.1 |
Concurrent infections, n (%) | 0 (0) | 3 (25) | 2 (40) |
NICU Admissions | 0 | 2 | 1 |
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Share and Cite
Costantino, M.; Marongiu, M.B.; Corbo, M.G.; Della Corte, A.M.; Frascogna, A.R.; Plantulli, A.; Campana, F.; Fortino, L.; Santoro, E.; Vozzella, E.A.; et al. Efficacy and Safety of Anti-Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab in Neonates: A Real-World Monocentric Study. Vaccines 2025, 13, 838. https://doi.org/10.3390/vaccines13080838
Costantino M, Marongiu MB, Corbo MG, Della Corte AM, Frascogna AR, Plantulli A, Campana F, Fortino L, Santoro E, Vozzella EA, et al. Efficacy and Safety of Anti-Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab in Neonates: A Real-World Monocentric Study. Vaccines. 2025; 13(8):838. https://doi.org/10.3390/vaccines13080838
Chicago/Turabian StyleCostantino, Maria, Mariagrazia Bathilde Marongiu, Maria Grazia Corbo, Anna Maria Della Corte, Anna Rita Frascogna, Angela Plantulli, Federica Campana, Luigi Fortino, Emanuela Santoro, Emilia Anna Vozzella, and et al. 2025. "Efficacy and Safety of Anti-Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab in Neonates: A Real-World Monocentric Study" Vaccines 13, no. 8: 838. https://doi.org/10.3390/vaccines13080838
APA StyleCostantino, M., Marongiu, M. B., Corbo, M. G., Della Corte, A. M., Frascogna, A. R., Plantulli, A., Campana, F., Fortino, L., Santoro, E., Vozzella, E. A., Longanella, W., Boccia, G., Filippelli, A., & De Caro, F. (2025). Efficacy and Safety of Anti-Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab in Neonates: A Real-World Monocentric Study. Vaccines, 13(8), 838. https://doi.org/10.3390/vaccines13080838