Antibody responses of Macaca fascicularis against a new inactivated polio vaccine derived from Sabin strains (sIPV) in DTaP-sIPV vaccine

An inactivated poliovirus vaccine using Sabin strains produced on the serum-free PER.C6® cell culture platform is immunogenic and safe in a non-human primate model

“…As we only used mature animals we do not address the effect of IPV maternal antibodies on PER.C6®-based sIPV immunogenicity, which may hamper sIPV vaccine take similar to current conventional IPV take in infants up to 14 weeks of age. NHP models closely mimic the human immune response, which enables the evaluation of human vaccination regimens, and are therefore more likely to be representative of the immunogenicity of sIPV in humans [8] , [9] , [24] .…”

“…Future studies will be directed towards the combination of the PER.C6®-based sIPV with other routine childhood vaccines in order to achieve a hexavalent vaccine formulation to provide protection at early age. For another sIPV product, the combination with diphtheria toxoid, tetanus toxoid, and an acellular pertussis antigens, was tested in an NHP model and found not to hamper the immunogenicity of the sIPV of the other vaccines [8] . However, this does not exclude immune interference for novel vaccines and novel combinations to achieve a hexavalent vaccine, which therefore should be tested in an appropriate animal model prior to human testing.…”

“…Because non-human primates (NHPs) are more closely related to humans than rats, it is likely that the outcome of a dose-finding immunogenicity study that mimics the human IPV immunization schedule of 3 prime- and 1 boost vaccination would be more predictive than other preclinical models. Hence, researchers working with sIPV vaccines generated on the Vero cell platform conducted preclinical dose-finding studies in cynomolgus monkeys before entering clinical trials [8] . An immunogenicity study performed in NHP with a quadrivalent combined diphtheria-tetanus-acellular pertussis-sIPV vaccine (DTaP-sIPV) showed a comparable neutralizing antibody response induced by Sabin types 1, 2 and 3 in DTaP-sIPV to the response induced by DTaP-cIPV and a stand-alone cIPV [9] .…”

Development and introduction of inactivated poliovirus vaccines derived from Sabin strains in Japan

“…Two manufacturers, Chemo-SeroTherapeutic Research Institute (Kaketsuken) and Biken completed preclinical and clinical studies of DTaP-sIPV, and then submitted the application for manufacturing approval to the PMDA in late 2011-early 2012 [57][58][59][60][61]. Both of the companies used a sIPV bulk stock, manufactured by JPRI, and combined it with their own licensed DTaP with aluminum adjuvants, to prepare the final DTaPsIPV products.…”