title: A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age.
abstract: BACKGROUND
  Respiratory syncytial virus (RSV) is a leading cause of infant morbidity and mortality. A recombinant RSV fusion protein nanoparticle vaccine (RSV F vaccine) candidate for maternal immunization was tested for safety and immunogenicity in women of childbearing age.
  
  
  METHODS
  Three hundred thirty women (18-35 years) were randomized to receive 1 or 2 doses of RSV F vaccine (60 or 90 µg) with or without aluminum phosphate adjuvant, or placebo at days 0 and 28. Safety was evaluated over 180 days; immunogenicity and RSV infection rates were evaluated over 112 days.
  
  
  RESULTS
  All vaccine formulations were well tolerated, without vaccine-related serious adverse events. Anti-F immunoglobulin G antibodies rose 6.5-15.6-fold, with significantly higher levels in 2-dose, adjuvanted regimens at day 56. Palivizumab-competitive antibody levels were undetectable at day 0 but increased up to 325 µg/mL at day 56. A 2.7- and 3.5-fold rise in RSV/A and RSV/B microneutralization antibodies were noted at day 56. Between days 56 and 112, 21% (12/56) of placebo recipients and 11% of vaccinees (26/244) showed evidence of a recent RSV infection (P = .04).
  
  
  CONCLUSIONS
  The vaccine appeared safe, immunogenic, and reduced RSV infections. Further development as a vaccine for use in maternal immunization is warranted.
  
  
  BACKGROUND
  NCT01704365.
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Glenn
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: Louis F
authors.initials: LF
authors.lastname: Fries
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: D Nigel
authors.initials: DN
authors.lastname: Thomas
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: Gale
authors.initials: G
authors.lastname: Smith
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: Eloi
authors.initials: E
authors.lastname: Kpamegan
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: Hanxin
authors.initials: H
authors.lastname: Lu
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: David
authors.initials: D
authors.lastname: Flyer
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: Dewal
authors.initials: D
authors.lastname: Jani
authors.affiliation: Novavax, Inc, Gaithersburg, Maryland.
authors.forename: Somia P
authors.initials: SP
authors.lastname: Hickman
authors.affiliation: Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine, Houston, Texas.
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Piedra
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D053758:Nanoparticles; D011993:Recombinant Fusion Proteins / Q000276:immunology*; D018357:Respiratory Syncytial Virus Infections / Q000517:prevention & control*; D012136:Respiratory Syncytial Viruses / Q000276:immunology*; D014765:Viral Vaccines / Q000276:immunology / Q000592:standards; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007074:Immunoglobulin G; D011993:Recombinant Fusion Proteins; D014765:Viral Vaccines
keywords: F or fusion protein; anti-F IgG; microneutralization; nanoparticle vaccine; palivizumab-competitive antibody (PCA); recombinant; respiratory syncytial virus (RSV)