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- Title
Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants.
- Authors
Muňoz, Flor M; Swamy, Geeta K; Hickman, Somia P; Agrawal, Sapeckshita; Piedra, Pedro A; Glenn, Gregory M; Patel, Nita; August, Allison M; Cho, Iksung; Fries, Louis
- Abstract
<bold>Background: </bold>Respiratory syncytial virus (RSV) is the leading cause of infant lower respiratory tract disease and hospitalization worldwide.<bold>Methods: </bold>Safety and immunogenicity of RSV fusion (F) protein nanoparticle vaccine or placebo were evaluated in 50 healthy third-trimester pregnant women. Assessments included vaccine tolerability and safety in women and infants, and RSV-specific antibody measures in women before and after vaccination, at delivery and post partum.<bold>Results: </bold>The vaccine was well tolerated; no meaningful differences in pregnancy or infant outcomes were observed between study groups. RSV-specific antibody levels increased significantly among vaccine recipients, including responses competitive with well-described monoclonal antibodies specific for multiple RSV neutralizing epitopes. No significant antibody increase was seen among placebo recipients, although a shallow upward trend across the RSV season was noted. Transplacental antibody transfer was 90%-120% across assays for infants of vaccinated women. Women with an interval of ≥30 days between vaccination and delivery demonstrated higher placental antibody transfer rates than women with an interval <30 days. Half-lives of RSV-specific antibodies in infants approximated 40 days. There was no evidence of severe RSV disease in infants of vaccinated mothers.<bold>Conclusions: </bold>Data from this phase 2 study support a maternal immunization strategy to protect infants from RSV disease.<bold>Clinical Trials Registration: </bold>NCT02247726.
- Subjects
RESPIRATORY syncytial virus; PREGNANT women; INFANTS; CLINICAL trial registries; RESPIRATORY diseases
- Publication
Journal of Infectious Diseases, 2019, Vol 220, Issue 11, p1802
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jiz390