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Maternal Respiratory Syncytial Virus (RSV) Vaccination: Current Status and Comparison to Monoclonal Antibodies (mAbs) for RSV Prevention in Infants and Children

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Aug 16, 2025

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Figure 1.

Key distinctions between maternal RSV and infant mAbs.
Key distinctions between maternal RSV and infant mAbs.

Studies on RSV Vaccine Development and Efficacy in Infants and Children

Study ID Type of Active Immunizing Agent Population Study Design Conclusion
Cunningham et al, 202022 Live Attenuated Vaccine 6–24 months Randomized control trial Two candidate vaccines were compared: RSV/ΔNS2/Δ1313/I1314L and RSV/276. Both vaccines were well tolerated, highly infectious, and immunogenic in children, showing potential for RSV vaccination in children aged 6–24 months.
McFarland et al, 201823 Live Attenuated Vaccine 6–24 months Randomized control trial The LID ΔM2-2 vaccine demonstrated good infectivity and immunogenicity in RSV-seronegative children, with a ≥4-fold increase in antibody levels and good protection in the subsequent RSV season.
McFarland et al, 202024 Live Attenuated Vaccine 6–24 months Randomized control trial The LID/ΔM2-2/1030s vaccine demonstrated high immunogenicity, with 95% of participants showing a ≥4-fold increase in serum RSV-neutralizing antibody levels.
Malkin et al, 201325 Live Attenuated Vaccine 6–24 months Randomized control trial MEDI-559 (live attenuated intranasal vaccine) showed good safety and sero-response (59% of recipients). It was well tolerated with mild and moderate side effects.
Belshe RB et al, 198215 Live Attenuated Vaccine Children under 24 months Field trial The live RSV vaccine administered parenterally was ineffective in preventing RSV infection during epidemics, highlighting challenges with live vaccine formulations.
Groothuis JR et al, 199816 Subunit-Based Vaccine (Purified F protein) Children under 12 months with bronchopulmonary dysplasia Clinical trial The purified F protein RSV vaccine (PFP-2) demonstrated safety, immunogenicity, and potential protection against severe RSV disease in children with bronchopulmonary dysplasia.
Tristram DA et al, 199317 Subunit-Based Vaccine (F glycoprotein) Children 18–36 months (seropositive for RSV) Clinical trial The F glycoprotein-based subunit vaccine showed promising results in preventing subsequent RSV infections in children who had previously been hospitalized for RSV without significant side effects.
Kim HW et al, 196918 Inactivated Vaccine (FI-RSV) Infants and young children Clinical trial Infants vaccinated with FI-RSV had a significantly higher risk of severe disease and hospitalization when later infected with RSV, leading to fatalities in two cases.
Graham BS, 201719 Review (Live Attenuated, Chimeric Virus Vaccines) N/A Review Live attenuated and live chimeric RSV vaccines are among the most promising candidates. Studies show that, unlike inactivated vaccine formulations, they do not trigger enhanced disease.
Tang RS et al, 200820 Vector-Based Vaccine (PIV-Vectored RSV Vaccine) Healthy adults Preclinical and initial clinical trial The PIV-vectored RSV vaccine was tested for safety and enhanced disease in healthy adults. It showed promise in the preclinical phase but required further investigation for broader use.
Wright PF et al, 200721 Live Attenuated Vaccine Children Clinical trial Live attenuated RSV vaccines did not cause enhanced disease after exposure to wild-type RSV, suggesting their potential safety in preventing RSV infections.

Studies on RSV Vaccination to Mothers During Pregnancy

Study ID Country Study Design Conclusion
Madhi et al, 202039 multicenter Randomized control trial The maternal RSV-F nanoparticle vaccine showed 40% efficacy against medically significant RSV lower respiratory infection in infants under 90 days, with variation between lower-middle-income countries (LMIC) and high-income countries (HIC) and had a good safety profile.
Bebia et al, 202340 multicenter Phase 2 Randomized Trial RSVPreF3 vaccine administered to pregnant women in the late second or third trimester showed a safe profile, robust immune response, successful antibody transfer to infants, and antibody persistence for at least six months post-birth.
Kampmann et al, 202341 multicenter Randomized control trial The trial investigated the effects of RSVpreF in over 3000 pregnant women and their infants. The vaccine demonstrated over 80% efficacy against severe illness within 90 days of birth and approximately 69% efficacy against severe illness within 180 days of birth.