A comparative study between outbred and inbred rat strains for the use in in vivo IPV potency testing

Bockstal, Viki; Sanders, Barbara P.; Achterberg, Rogier; Tiemessen, Machteld M.; Bogaert, Lies; Meer, Marjolein van der; Schuitemaker, Hanneke; Zahn, Roland

doi:10.1016/j.vaccine.2018.04.024

Cited by 4 publications

(2 citation statements)

References 8 publications

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“…The animal studies were reviewed and approved by the Animal Care and Use Review Office (ACURO) of the U.S. Army Medical Research and Development Command (USAMRDC) and the Institutional Animal Care and Use Committee (I-ACUC) of Sobran Bioservices, Inc. All rat studies were performed at Sobran Bioservices, Inc. (Baltimore, MD) under humane conditions by trained personnel. Wistar rats, a widely accepted animal model for polio vaccine analysis [29,32], between 6 and 8 weeks of age and of mixed sex were used for immunization studies. A total of 180 rats were used in these studies.…”

Section: Rat Immunizationmentioning

confidence: 99%

A novel gamma radiation-inactivated sabin-based polio vaccine

Tobin

Gaidamakova

et al. 2020

PLoS ONE

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A concerted action on the part of international agencies and national governments has resulted in the near-eradication of poliomyelitis. However, both the oral polio vaccine (OPV) and the inactivated polio vaccine (IPV) have deficiencies which make them suboptimal for use after global eradication. OPV is composed of attenuated Sabin strains and stimulates robust immunity, but may revert to neurovirulent forms in the intestine which can be shed and infect susceptible contacts. The majority of IPV products are manufactured using pathogenic strains inactivated with formalin. Upon eradication, the production of large quantities of pathogenic virus will present an increased biosecurity hazard. A logical ideal endgame vaccine would be an inactivated form of an attenuated strain that could afford protective immunity while safely producing larger numbers of doses per unit of virus stock than current vaccines. We report here the development of an ionizing radiation (IR)-inactivated Sabinbased vaccine using a reconstituted Mn-decapeptide (MDP) antioxidant complex derived from the radioresistant bacterium Deinococcus radiodurans. In bacteria, Mn 2+ -peptide antioxidants protect proteins from oxidative damage caused by extreme radiation exposure. Here we show for the first time, that MDP can protect immunogenic neutralizing epitopes in picornaviruses. MDP protects epitopes in Polio Virus 1 and 2 Sabin strains (PV1-S and PV2-S, respectively), but viral genomic RNA is not protected during supralethal irradiation. IR-inactivated Sabin viruses stimulated equivalent or improved neutralizing antibody responses in Wistar rats compared to the commercially used IPV products. Our approach reduces the biosecurity risk of the current PV vaccine production method by utilizing the Sabin strains instead of the wild type neurovirulent strains. Additionally, the IR-inactivation approach could provide a simpler, faster and less costly process for producing a more immunogenic IPV. Gamma-irradiation is a well-known method of virus inactivation and this vaccine approach could be adapted to any pathogen of interest.

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Section: Rat Immunizationmentioning

confidence: 99%

A novel gamma radiation-inactivated sabin-based polio vaccine

Tobin

Gaidamakova

et al. 2020

PLoS ONE

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“…However, previous investigations have shown that the Wistar rat model is not optimal for dose-finding studies of new sIPV vaccines, especially for type 2. Indeed, different immunogenicity profiles for poliovirus type 2 between Salk and Sabin based vaccine strains were observed in this rat model, while these vaccines showed comparable immunogenicity in Phase II and III clinical trials [7] , [11] , [12] , [25] , [26] . Consistent with these observations, we also observed lower immunogenicity and reduced potency of Sabin type 2 versus BRP2 in the Wistar rat model ( Fig.…”

Section: Discussionmentioning

confidence: 83%

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

Bockstal

Tiemessen

Achterberg

et al. 2018

Vaccine

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BackgroundThe World Health Organization recommends the development of affordable next-generation inactivated poliovirus vaccines (IPV) using attenuated poliovirus Sabin strains. Previously, we introduced a novel PER.C6® cell culture platform, which allows for high yield production of an affordable trivalent Sabin IPV vaccine.MethodsImmunogenicity and safety of this novel PER.C6®-based Sabin-IPV (sIPV) was assessed in rats and non-human primates (NHPs). NHPs received one of four different dose dilutions vaccine according to current human schedule (three prime-immunizations and one boost immunization). For comparison, NHPs received commercially available reference Salk IPV or sIPV.ResultsDose-dependent immunogenicity and good tolerability was observed for the PER.C6®-based sIPV formulations in rats and NHPs. In NHPs, the lowest tested dose that induced anti-Sabin virus-neutralizing antibody titers that were non-inferior to commercial sIPV after three immunizations was 5-7.5-25 D-antigen units for type 1, 2 and 3 respectively.DiscussionPER.C6®-based sIPV induced comparable immunogenicity to commercial Salk IPV and sIPV vaccines in NHPs. Together with the absence of any preclinical safety signals, these data warrant further testing in clinical trials. sIPV produced on the PER.C6® cell platform could be one solution to the need for an affordable and immunogenic IPV to achieve and maintain global polio eradication.

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Poliovirus Vaccine—Inactivated

Vidor¹,

Modlin²

2023

Plotkin's Vaccines

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A comparative study between outbred and inbred rat strains for the use in in vivo IPV potency testing

Cited by 4 publications

References 8 publications

A novel gamma radiation-inactivated sabin-based polio vaccine

A novel gamma radiation-inactivated sabin-based polio 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

Poliovirus Vaccine—Inactivated

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