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. 2021 May 29;9(6):565.
doi: 10.3390/vaccines9060565.

Immunogenicity and Safety of Inactivated Sabin-Strain Polio Vaccine "PoliovacSin": Clinical Trials Phase I and II

Anastasia Piniaeva  1 , Georgy Ignatyev  1 , Liubov Kozlovskaya  1   2 , Yury Ivin  1 , Anastasia Kovpak  1 , Alexander Ivanov  1 , Anna Shishova  1   2 , Liliia Antonova  1 , Yusuf Khapchaev  1 , Irina Feldblium  3 , Olga Ivanova  1   2 , Aleksandra Siniugina  1 , Aydar Ishmukhametov  1   2
Affiliations

Immunogenicity and Safety of Inactivated Sabin-Strain Polio Vaccine "PoliovacSin": Clinical Trials Phase I and II

Anastasia Piniaeva et al. Vaccines (Basel). .

Abstract

Global polio eradication requires both safe and effective vaccines, and safe production processes. Sabin oral poliomyelitis vaccine (OPV) strains can evolve to virulent viruses and result in poliomyelitis outbreaks, and conventional inactivated poliomyelitis vaccine (Salk-IPV) production includes accumulation of large stocks of neurovirulent wild polioviruses. Therefore, IPV based on attenuated OPV strains seems a viable option. To increase the global supply of affordable inactivated vaccine in the still not-polio free world we developed an IPV made from the Sabin strains-PoliovacSin. Clinical trials included participants 18-60 years of age. A phase I single-center, randomized, double-blind placebo-controlled clinical trial included 60 participants, who received one dose of PoliovacSin or Placebo. A phase II multicenter, randomized, double-blind, comparative clinical trial included 200 participants, who received one dose of PoliovacSin or Imovax Polio. All vaccinations were well tolerated, and PoliovacSin had a comparable safety profile to the Placebo or the reference Imovax Polio preparations. A significant increase in neutralizing antibody levels to polioviruses types 1-3 (Sabin and wild) was observed in PoliovacSin and Imovax Polio vaccinated groups. Therefore, clinical trials confirmed good tolerability, low reactogenicity, and high safety profile of the PoliovacSin and its pronounced immunogenic properties. The preparation was approved for clinical trials involving infants.

Keywords: IPV; Sabin strain; clinical trial; inactivated vaccine; poliovirus.

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Conflict of interest statement

FSBSI “Chumakov FSC R&D IBP RAS” is a polio vaccine producer. AP, GI, YI, AK, AI, ASh, LA, YK, ASin and AI work for the manufacturing unit. The remaining authors declare no competing interests.

Figures

Figure 1
Figure 1
Participant flow through the study. Phase I.
Figure 2
Figure 2
Participant flow through the study. Phase II.
Figure 3
Figure 3
nAB titers against vaccine PV strains Sabin 1-3 and wild PV strains Mahoney (type 1), MEF (type 2) and Saukett (type 3) detected in the serum of Phase II participants before and after vaccination: (A) absolute values (B) Delta between the nAB titers against before and after vaccination. The differences between delta values of nAB titer induced by PoliovacSin and Imovax polio are statistically insignificant (Mann–Whitney test, p < 0.05).
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