The company “Nanolek” is commencing the final stage of the clinical trial of its vaccine against the human papillomavirus (HPV) among children and adolescents aged 9 to 17. This research marks the last step before releasing the vaccine to the Russian market.
The study, set to begin in March 2024 and run until October 2025, will involve 402 volunteers. This vaccine will become the first domestic HPV vaccine.
“Preventing cervical cancer is a socially significant and important issue. The vaccine against the human papillomavirus is the first and most crucial key to this prevention. It is planned to include this vaccine in the national vaccination schedule for girls aged 8 to 13-14 in the future,” comments Svetlana Zakirova, Deputy General Director for Research and Development at Nanolek.
Currently, only foreign vaccines are registered and used in Russia to combat this virus, and they are expensive and not accessible to everyone. However, the upcoming domestic vaccine aims to rectify this situation. It will provide protection against the four most common types of HPV: 6, 11, 16, and 18, which cause various oncological diseases. The vaccine will be manufactured at the Nanolek plant in the Kirov region.
The research on the Russian vaccine will involve three Moscow federal research centers: the First Moscow State Medical University named after I.M. Sechenov, the National Medical Research Center of Obstetrics, Gynecology, and Perinatology named after Academician V.I. Kulakov, and the Russian Scientific Center of Surgery named after Academician B.V. Petrovsky. Additionally, Perm State Medical University named after Academician Wagner, Children’s City Clinical Hospital No. 11 in Yekaterinburg, and LLC “Medical Technologies” from St. Petersburg will participate in the study.
The company completed the third phase of clinical trials in 2023, involving adults aged 18 to 45. This stage confirmed the vaccine’s safety and effectiveness, inducing the production of antibodies against the four most common oncogenic types of HPV. The company emphasizes that the results of previous studies confirm the vaccine’s good tolerability, favorable safety profile, and potentially high efficacy.
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