Journal Article

Efficacy of monoclonal antibodies and maternal vaccination for prophylaxis of respiratory syncytial virus disease

Lommerse, Jos, Lee, Andrew W., Plock, Nele, Sachs, Jeffrey R., Cheung, S. Y. Amy, Maas, Brian M., Vora, Kalpit A., Zang, Xiaowei

2025

Overview

Background Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infection in infants and young children. The level of serum neutralizing antibodies (SNAs) is often used as a measure of protection against respiratory syncytial virus (RSV) infection. Methods A qualified, model-based, meta-analysis efficacy prediction framework was used to understand the maternal vaccination-induced fold-increase in SNA titers necessary to achieve, over several study observation periods and study populations, similar protection to that of the monoclonal antibody clesrovimab (MK-1654). Results Simulations indicated that 3-month and 6-month efficacy comparable to that predicted for passive immunization (clesrovimab) would require a maternal vaccine to increase SNA titers by 30- and 60-fold, respectively, higher than observed increases reported to date. Efficacy of maternal vaccination was predicted (for vaccines similar to those with published data) to be substantially lower for preterm infants compared to full-term infants, and substantially less over 6 months than over 3 months. Efficacy of passive immunization was predicted to be similar or higher in preterm infants than full-term infants and was similar for 3- and 6-month observation periods. Conclusions Modeling can be used to reliably predict the efficacy of maternal vaccination for preventing RSV in infants. Passive immunization (e.g., with clesrovimab) is likely to provide more protection for preterm infants and for infants born outside the RSV season than that provided by current maternal vaccines. Maternal vaccination may provide partial protection from RSV disease to full-term infants born just prior to or during the RSV season. Plain language summary Infection with respiratory syncytial virus (RSV) can lead to RSV disease, a respiratory illness which can lead to hospitalization in infants and young children. Two approaches for preventing RSV disease are immunization of the infant after birth and vaccination of pregnant people before delivery (maternal vaccination). We compared these two approaches with a computer model to predict which is more effective. Our results predict that immunization of both preterm and full-term infants could protect against RSV disease better than maternal vaccination. Maternal vaccination is predicted to partially protect full-term infants who are born just before, or during, a season when RSV is more common. Our results suggest immunization schedules (for infants) could potentially be timed with the seasons to protect even better against RSV disease. Plock et al. integrate clinical efficacy data on monoclonal antibodies and maternal vaccination for prevention of RSV disease in infants. Monoclonal antibodies are predicted to be more efficacious than maternal vaccination in preterm and full-term infants with maternal vaccination expected to partially protect full-term infants born just before, or during, an RSV season.

• Publisher: Nature Publishing Group UK,Springer Nature B.V,Nature Portfolio
• Subject: 692/308/153 / 692/308/3187 / 692/699/255/2514 / Clinical trials / Coronaviruses / COVID-19 / Disease prevention / Hospitalization / Infections / Medicine / Medicine & Public Health / Monoclonal antibodies / Newborn babies / Premature babies / Respiratory syncytial virus / Simulation / Vaccines