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Correlation between anthrax lethal toxin neutralizing antibody levels and survival in guinea pigs and nonhuman primates vaccinated with the AV7909 anthrax vaccine candidate.
Savransky, Vladimir; Shearer, Jeffry D; Gainey, Melicia R; Sanford, Daniel C; Sivko, Gloria S; Stark, Gregory V; Li, Na; Ionin, Boris; Lacy, Michael J; Skiadopoulos, Mario H.
Afiliación
  • Savransky V; Emergent BioSolutions Inc., 300 Professional Drive, Gaithersburg, MD 20879, USA.
  • Shearer JD; Emergent BioSolutions Inc., 300 Professional Drive, Gaithersburg, MD 20879, USA.
  • Gainey MR; Battelle, Columbus, OH 43201, USA.
  • Sanford DC; Battelle, Columbus, OH 43201, USA.
  • Sivko GS; Battelle, Columbus, OH 43201, USA.
  • Stark GV; Battelle, Columbus, OH 43201, USA.
  • Li N; Emergent BioSolutions Inc., 300 Professional Drive, Gaithersburg, MD 20879, USA.
  • Ionin B; Emergent BioSolutions Inc., 300 Professional Drive, Gaithersburg, MD 20879, USA.
  • Lacy MJ; Emergent BioSolutions Inc., 300 Professional Drive, Gaithersburg, MD 20879, USA.
  • Skiadopoulos MH; Emergent BioSolutions Inc., 300 Professional Drive, Gaithersburg, MD 20879, USA. Electronic address: SkiadopoulosM@ebsi.com.
Vaccine ; 35(37): 4952-4959, 2017 09 05.
Article en En | MEDLINE | ID: mdl-28774566
The anthrax vaccine candidate AV7909 is being developed as a next generation vaccine for a post-exposure prophylaxis (PEP) indication against anthrax. AV7909 consists of the Anthrax Vaccine Adsorbed (AVA, BioThrax®) bulk drug substance adjuvanted with the immunostimulatory oligodeoxynucleotide (ODN) compound, CPG 7909. The addition of CPG 7909 to AVA enhances both the magnitude and the kinetics of antibody responses in animals and human subjects, making AV7909 a suitable next-generation vaccine for use in a PEP setting. The studies described here provide initial information on AV7909-induced toxin-neutralizing antibody (TNA) levels associated with the protection of animals from lethal Bacillus anthracis challenge. Guinea pigs or nonhuman primates (NHPs) were immunized on Days 0 and 28 with various dilutions of AV7909, AVA or a saline or Alhydrogel+CPG 7909 control. Animals were challenged via the inhalational route with a lethal dose of aerosolized B. anthracis (Ames strain) spores and observed for clinical signs of disease and mortality. The relationship between pre-challenge serum TNA levels and survival following challenge was determined in order to calculate a threshold TNA level associated with protection. Immunisation with AV7909 induced a rapid, highly protective TNA response in guinea pigs and NHPs. Surprisingly, the TNA threshold associated with a 70% probability of survival for AV7909 immunized animals was substantially lower than the threshold which has been established for the licensed AVA vaccine. The results of this study suggest that the TNA threshold of protection against anthrax could be modified by the addition of an immune stimulant such as CPG 7909 and that the TNA levels associated with protection may be vaccine-specific.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas contra el Carbunco / Anticuerpos Neutralizantes Límite: Animals Idioma: En Revista: Vaccine Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas contra el Carbunco / Anticuerpos Neutralizantes Límite: Animals Idioma: En Revista: Vaccine Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos