Purification and protective efficacy of monomeric and modified Yersinia pestis capsular F1-V antigen fusion proteins for vaccination against plague

Protein Expr Purif. 2007 May;53(1):63-79. doi: 10.1016/j.pep.2006.12.018. Epub 2006 Dec 31.

Abstract

The F1-V vaccine antigen, protective against Yersinia pestis, exhibits a strong tendency to multimerize that affects larger-scale manufacture and characterization. In this work, the sole F1-V cysteine was replaced with serine by site-directed mutagenesis for characterization of F1-V non-covalent multimer interactions and protective potency without participation by disulfide-linkages. F1-V and F1-V(C424S) proteins were overexpressed in Escherichia coli, recovered using mechanical lysis/pH-modulation and purified from urea-solubilized soft inclusion bodies, using successive ion-exchange, ceramic hydroxyapatite, and size-exclusion chromatography. This purification method resulted in up to 2mg/g of cell paste of 95% pure, mono-disperse protein having < or =0.5 endotoxin units per mg by a kinetic chromogenic limulus amoebocyte lysate reactivity assay. Both F1-V and F1-V(C424S) were monomeric at pH 10.0 and progressively self-associated as pH conditions decreased to pH 6.0. Solution additives were screened for their ability to inhibit F1-V self-association at pH 6.5. An L-arginine buffer provided the greatest stabilizing effect. Conversion to >500-kDa multimers occurred between pH 6.0 and 5.0. Conditions for efficient F1-V adsorption to the cGMP-compatible alhydrogel adjuvant were optimized. Side-by-side evaluation for protective potency against subcutaneous plague infection in mice was conducted for F1-V(C424S) monomer; cysteine-capped F1-V monomer; cysteine-capped F1-V multimer; and a F1-V standard reported previously. After a two-dose vaccination with 2 x 20 microg of F1-V, respectively, 100%, 80%, 80%, and 70% of injected mice survived a subcutaneous lethal plague challenge with 10(8) LD(50)Y. pestis CO92. Thus, vaccination with F1-V monomer and multimeric forms resulted in significant, and essentially equivalent, protection.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Amino Acid Sequence
  • Amino Acid Substitution
  • Animals
  • Animals, Outbred Strains
  • Antigens, Bacterial / administration & dosage
  • Antigens, Bacterial / genetics
  • Antigens, Bacterial / isolation & purification*
  • Bacterial Proteins / chemistry
  • Bacterial Proteins / genetics
  • Bacterial Proteins / immunology
  • Bacterial Proteins / isolation & purification*
  • Bacterial Proteins / pharmacology
  • Bacterial Vaccines / immunology
  • Buffers
  • Chromatography, Gel
  • Chromatography, Ion Exchange
  • Drug Evaluation, Preclinical
  • Escherichia coli / genetics
  • Female
  • Hydrogen-Ion Concentration
  • Inclusion Bodies / chemistry
  • Inclusion Bodies / drug effects
  • Light
  • Limulus Test
  • Mice
  • Molecular Sequence Data
  • Peptide Mapping
  • Plague / immunology
  • Plague / prevention & control*
  • Plague Vaccine / genetics
  • Plague Vaccine / immunology
  • Plague Vaccine / pharmacology*
  • Recombinant Fusion Proteins / chemistry
  • Recombinant Fusion Proteins / immunology
  • Recombinant Fusion Proteins / isolation & purification
  • Scattering, Radiation
  • Serine / metabolism
  • Solubility
  • Survival Rate
  • Treatment Outcome
  • Urea / pharmacology
  • Vaccination*
  • Vaccines, Synthetic / administration & dosage
  • Yersinia pestis / immunology*
  • Yersinia pestis / pathogenicity

Substances

  • Antigens, Bacterial
  • Bacterial Proteins
  • Bacterial Vaccines
  • Buffers
  • Plague Vaccine
  • Recombinant Fusion Proteins
  • Vaccines, Synthetic
  • caf1 protein, Yersinia pestis
  • Serine
  • Urea