_17.11.2023. The biopharmaceutical company Nanolek has announced the successful completion of Phase III clinical trials on the safety and efficacy of a vaccine against human papillomavirus (HPV), which causes cervical cancer. As part of the study, Nanolek's in-house vaccine demonstrated comparability to that of a vaccine produced by the American firm MSD in terms of efficacy, safety, and the formation of immunity to four types of HPV. The study was conducted and based on five clinical centers with the participation of 440 healthy adults ranging in age from 18 to 45. _
The Russian vaccine showed comparable immunogenicity, as most of the study's participants developed antibodies to all four of the most common oncogenic types of HPV (6, 11, 16, and 18), all of which the Nanolek vaccine protects against.
Cervical cancer ranks among the leaders in terms of mortality among women of reproductive age in Russia, that is, among the most active and able-bodied individuals (up to the age of 44). It is second in terms of prevalence among oncological diseases in women aged 14-45.
In 2020 Nanolek announced the launch of a project to develop and market an HPV vaccine. This virus causes HPV-associated diseases, including cervical cancer, anogenital warts, etc. Only foreign HPV vaccines are currently registered and used in Russia. Nanolek's vaccine will be the first domestic HPV vaccine. The Russian vaccine is planned to enter the market in 2025.
Nanolek announced plans at the end of October 2023 to produce a full-cycle HPV vaccine, including the substance, at its plant in the Kirov Region. The company is investing 5 billion rubles in the creation of new capacities for the production of the HPV vaccine as well as a number of other vaccines, all taking into account world standards of production and quality assurance, that is, Good Manufacturing Practices.
The new domestic vaccine will be registered in Russia under the trade name Tsegardex. "According to Government Decree No. 774-r dated March 29, 2021, inclusion of the HPV vaccination into the National Immunization Schedule is planned for 2026. Thanks to this, the Russian vaccine will be available for vaccination of adolescents and will help ensure their protection from the most oncogenic types of the virus," commented Nanolek CEO Vladimir Nesterenko.
About the research into the Russian HPV vaccine
In 2021 the Russian HPV vaccine successfully passed Phase I clinical trials, demonstrating at this early stage, the safety and immunogenicity indicators of the new Tsegardex vaccine as being comparable to those of a similar American drug manufactured by MSD (U.S.A.) registered in the Russian Federation.
Tsegardex was also compared with the American-made vaccine as part of Phase III clinical trials in 2023. The study was conducted on healthy and previously unvaccinated adults aged 18 to 45.
Both vaccines demonstrated a high tolerance and safety profile in the study, with the reactions observed mainly represented by local reactions at the site of vaccine administration. The Tsegardex and MSD vaccines are comparable in terms of safety and immunogenicity.
The multicenter study was conducted at several clinical hubs: the Kirov State Medical University, the Eco-Safety Research Center in St. Petersburg, the E.A. Wagner Perm State Medical University, as well as Medical and Hygiene Unit No. 163 of the Federal Medical and Biological Agency.
Phase III clinical trials on adolescents aged 9-17 are planned in 2024.
The new vaccine, Tsegardex, is expected to enter the Russian market in 2025.