Safety and immunogenicity of a recombinant parvovirus B19 vaccine formulated with MF59C.1

J Infect Dis. 2003 Feb 15;187(4):675-8. doi: 10.1086/368382. Epub 2003 Feb 7.

Abstract

A recombinant human parvovirus B19 vaccine (MEDI-491; MedImmune) composed of the VP1 and VP2 capsid proteins and formulated with MF59C.1 adjuvant was evaluated in a randomized, double-blind, phase 1 trial. Parvovirus B19-seronegative adults (n=24) received either 2.5 or 25 microg MEDI-491 at 0, 1, and 6 months. MEDI-491 was safe and immunogenic. All volunteers developed neutralizing antibody titers that peaked after the third immunization and were sustained through study day 364.

Publication types

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

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Adolescent
  • Adult
  • Antibodies, Viral / blood
  • Capsid / immunology*
  • Capsid Proteins*
  • Double-Blind Method
  • Humans
  • Immunization Schedule
  • Injections, Intramuscular
  • Middle Aged
  • Neutralization Tests
  • Parvoviridae Infections / blood
  • Parvoviridae Infections / prevention & control*
  • Parvovirus / immunology*
  • Polysorbates / administration & dosage*
  • Squalene / administration & dosage*
  • Vaccination*
  • Vaccines, Synthetic / administration & dosage
  • Viral Vaccines / administration & dosage*
  • Viral Vaccines / immunology*

Substances

  • Adjuvants, Immunologic
  • Antibodies, Viral
  • Capsid Proteins
  • MF59 oil emulsion
  • Polysorbates
  • Vaccines, Synthetic
  • Viral Vaccines
  • capsid protein VP1, parvovirus B19
  • capsid protein VP2, parvovirus B19
  • Squalene