Summary of the included clinical trials that assessed maternal RSV vaccine efficacy
| Record | Title | Design | Vaccine | Population | Follow-up period | Vaccine efficacy |
|---|---|---|---|---|---|---|
| Kampmann et al. [59] | Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants | Phase 3, double-blind clinical trial. MATISSE ClinicalTrials.gov number: NCT04424316 | Bivalent RSV prefusion F protein-based (RSVpreF) vaccine funded by Pfizer | Pregnant women at 24 through 36 weeks’ gestation. 3,682 maternal participants received the vaccine, and 3,676 received placebo; 3,570 and 3,558 infants, respectively, were evaluated | 180 days after birth | 81.8% efficacy against severe RSV-LRTI at 90 days (99.5% CI, 40.6–96.3); 69.4% at 180 days (97.58% CI, 44.3–84.1); 57.1% efficacy against medically attended RSV-LRTI at 90 days (99.5% CI, 14.7–79.8) |
| Simões et al. [60] | Prefusion F protein-based respiratory syncytial virus immunization in pregnancy | Phase 2b, double-blind clinical trial. ClinicalTrials.gov number: NCT04032093 | Bivalent RSV prefusion F protein-based (RSVpreF) vaccine funded by Pfizer | 406 women and 403 infants; 327 women (80.5%) received RSVpreF vaccine | 6 months after birth | Post hoc exploratory efficacy analyses showed efficacy of 84.7% (95% CI: 21.6–97.6) and 91.5% (95% CI: –5.6–99.8) for medically attended and severe medically attended RSV-associated lower respiratory tract illness, respectively |
| Madhi et al. [61] | Respiratory syncytial virus vaccination during pregnancy and effects in infants | Phase 3, observer-blind, placebo-controlled clinical trial. ClinicalTrials.gov number: NCT02624947 | Recombinant RSV F-nanoparticle vaccine (RSV-F vaccine) funded by Novavax and the Bill and Melinda Gates Foundation | Pregnant women aged 14–40 years, 28–36 weeks’ gestation; 4,636 randomized; 4,579 live births | 180 days after birth | 39.4% efficacy against RSV-LRTI at 90 days (97.52% CI, –1.0 to 63.7); 48.3% against RSV-LRTI with severe hypoxemia (95% CI, –8.2 to 75.3); 44.4% efficacy against RSV-LRTI hospitalization (95% CI, 19.6 to 61.5) |
| Dieussaert et al. [42] | RSV prefusion F protein-based maternal vaccine—preterm birth and other outcomes | Phase 3, double-blind, randomized, placebo-controlled clinical trial. ClinicalTrials.gov number: NCT04605159 | Subunit vaccine (RSVPreF3-Mat) based on the RSV F protein, funded by GlaxoSmithKline Biologicals | 5,328 pregnant women and 5,233 infants. A total of 3,426 infants in the vaccine group and 1,711 infants in the placebo group were followed from birth to 6 months of age | 6 months after birth | 65.5% efficacy against RSV-LRTI at 6 months (95% CrI, 37.5–82.0); 69.0% efficacy against severe RSV-LRTI (95% CrI, 33.0–87.6) |
| Banooni et al. [62] | Efficacy, immunogenicity, and safety of an investigational maternal respiratory syncytial virus prefusion F protein-based vaccine | Double-blind, randomized, placebo-controlled, phase 3 trial. ClinicalTrials.gov number: NCT04605159 | Subunit vaccine (RSVPreF3-Mat) based on the RSV F protein, funded by GlaxoSmithKline Biologicals | Women 18–49 years old were randomized 2:1 to receive one dose of RSVPreF3-Mat (n = 3,557) or placebo (n = 1,771) at 240/7–340/7 weeks’ gestation | 6 months after birth | 65.5% efficacy against MA-RSV-LRTD (95% CrI, 37.5–82.0); 69.0% against severe MA-RSV-LRTD (95% CrI, 33.0–87.6); 50.1% against hospitalization (95% CrI, –3.6–75.8); efficacy was higher in high-income (75.9%) vs. low-/middle-income (47.8%) countries; efficacy waned after 6 months |
RSV: respiratory syncytial virus; LRTI: lower respiratory tract infection; CI: confidence interval; CrI: credible interval; F: fusion
Malik S: Conceptualization, Methodology, Formal analysis, Validation, Investigation, Resources, Data curation, Writing—original draft, Writing—review & editing, Visualization, Supervision, Project administration, Software. HN: Methodology, Formal analysis, Validation, Investigation, Data curation, Writing—review & editing. AAS: Methodology, Formal analysis, Validation, Investigation, Data curation, Writing—review & editing. Mohammed S: Conceptualization, Methodology, Formal analysis, Validation, Resources, Investigation, Data curation, Writing—review & editing, Supervision, Project administration, Software. All authors have read and agreed to the published version of the manuscript.
The authors declare that they have no conflicts of interest.
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