Immunogenicity and safety of respiratory syncytial virus subunit vaccine in seropositive children 18-36 months old

J Infect Dis. 1993 Jan;167(1):191-5. doi: 10.1093/infdis/167.1.191.


Twenty-six children (aged 18-36 months) previously hospitalized for respiratory syncytial virus (RSV) infection were randomized to receive 50 micrograms of an RSV subunit vaccine composed primarily of F glycoprotein or saline placebo by intramuscular injection. Serum was obtained at entry and at 1 and 6 months after vaccination for detection of antibody to F glycoprotein and G glycoprotein of subtypes A (Ga) or B (Gb) and of neutralizing antibody (nAb). At 1 month, by comparing the baseline values, vaccinees had statistically significant increases in geometric mean antibody titer (GMT) of more than fourfold to F (P = .0001), Ga (P = .0001), Gb (P = .003), and nAb (P = .009). No differences in GMT were observed between F protein vaccine and placebo recipients at entry, nor between placebo recipients at entry and 1 month. RSV infections were identified in 7 placebo recipients (4 by both viral identification and seroconversion, 3 by seroconversion alone). No vaccine recipient had RSV infection documented in the 6 months after vaccination (P = .003). There were no significant vaccine-related side effects, and no evidence of enhanced respiratory illnesses was observed. The subunit F protein vaccine appears safe and immunogenic and may prevent infection in healthy children primed by prior RSV infection.

Publication types

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

MeSH terms

  • Antibodies, Viral / analysis*
  • Antibodies, Viral / blood
  • Child, Preschool
  • Female
  • HN Protein*
  • Humans
  • Immunoglobulin A, Secretory / analysis
  • Immunoglobulin E / analysis
  • Immunoglobulin G / blood
  • Infant
  • Male
  • Respiratory Syncytial Viruses / immunology*
  • Viral Envelope Proteins
  • Viral Proteins / immunology*
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology*


  • Antibodies, Viral
  • HN Protein
  • Immunoglobulin A, Secretory
  • Immunoglobulin G
  • Viral Envelope Proteins
  • Viral Proteins
  • Viral Vaccines
  • attachment protein G
  • Immunoglobulin E