As part of the VII All-Russian Symposium with international participation ‘Papillomavirus infection and cancer: epidemiology, diagnosis, vaccine prophylaxis’ held at the Pasteur Research Institute of Epidemiology and Microbiology (St. Petersburg), the results of a phase III comparative clinical trial of the first Russian quadrivalent HPV vaccine for adult volunteers were presented to the medical community for the first time.

One of the main researchers, the head of the Department of Epidemiology of Academician Wagner PGMU, Doctor of Medical Sciences, Professor Irina Feldblum said that 440 volunteers aged 18 to 45 years took part in the study, of whom 220 received the new domestic vaccine and 220 received a comparison preparation (quadrivalent vaccine of foreign production).

The domestic drug, jointly developed by Nanolek LLC and CJSC SPC Kombiotech, showed no less immunogenicity and efficiency. The majority of volunteers developed antibodies to all vaccine types - the four most common oncogenic types of HPV. The studies confirm good tolerability, favorable safety profile and potentially high efficacy of the Russian vaccine*.

Alexey Ekimov, Director of the Nanolek Research and Production Centre for Pharmaceutical Development, also highlighted that prophylactic HPV vaccines are incapable of infection because they do not contain the viral genome. This makes the drug safer.

The new domestic vaccine can protect against the four most common types of HPV - 6, 11, 16, 18, which cause cervical cancer and other HPV-associated cancers and benign diseases, including anogenital warts. This is very important because in Russia, cervical cancer ranks first in cancer mortality and second in prevalence among women under the age of 44.

Clinical trials of the vaccine are currently underway involving healthy children aged 9-17. The project is being implemented in line with the key directions of the Strategy for the Development of Immunoprophylaxis of Infectious Diseases until 2035 and the Strategy for the Development of the Pharmaceutical Industry until 2030.

The Russian HPV vaccine will be produced at Nanolek's production site in the Kirov region. The company's existing production capacity will fully cover the needs of the healthcare ministry system for this vaccine.

*A multicentre, randomised, parallel-group comparative study to evaluate the immunogenicity, tolerability and safety of recombinant quadrivalent (types 6, 11, 16, 18) human papillomavirus vaccine in volunteers. The study was conducted between July 2022 and March 2023 Unpublished data. Planned publication date is 2025.