A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age

J Infect Dis. 2016 Feb 1;213(3):411-22. doi: 10.1093/infdis/jiv406. Epub 2015 Aug 10.


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.

Clinical trials registration: NCT01704365.

Keywords: F or fusion protein; anti-F IgG; microneutralization; nanoparticle vaccine; palivizumab-competitive antibody (PCA); recombinant; respiratory syncytial virus (RSV).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adolescent
  • Adult
  • Antibodies, Viral / blood
  • Dose-Response Relationship, Immunologic
  • Female
  • Humans
  • Immunoglobulin G / blood
  • Nanoparticles
  • Recombinant Fusion Proteins / immunology*
  • Respiratory Syncytial Virus Infections / prevention & control*
  • Respiratory Syncytial Viruses / immunology*
  • Viral Vaccines* / immunology
  • Viral Vaccines* / standards
  • Young Adult


  • Adjuvants, Immunologic
  • Antibodies, Viral
  • Immunoglobulin G
  • Recombinant Fusion Proteins
  • Viral Vaccines

Associated data

  • ClinicalTrials.gov/NCT01704365