Nanolek biopharmaceutical company has received permission from the Ministry of Health of the Russian Federation for phase 3 clinical trials of HPV vaccine on adult patients, as the company’s press service reported. This will be Russia’s first domestic HPV vaccine, with its market launch planned for the end of 2024. It is expected to be included in the National Calendar of Vaccinations in two years.
Nanolek develops a tetravalent recombinant (types 6, 11, 16, 18) HPV vaccine in partnership with Combiotech, with the purchase of full rights to the product.
“The goal of phase 3 of the clinical trial is to evaluate the effectiveness, immunogenicity, and safety of the vaccine on a large sample of people (440 participants), in contrast to phase 1, where several dozen volunteers are involved. During the final phase, it is easier to identify possible adverse events that are difficult to track with a small number of patients,” Svetlana Zakirova, Deputy General Director of Nanolek for Research and Development, commented.
As part of the trial, the domestic drug will continue to be compared with Gardasil® vaccine from Merck Sharp & Dohme (USA). At the first stage of phase 3, the vaccine will be tested on adults aged 18 to 45. The multicenter study will take place in several clinical centers: Kirov State Medical University, the Eco-Safety Research Center (St. Petersburg), Perm State Medical University named after Academician E. A. Wagner, and Primary Healthcare Unit No. 163 of the Federal Medical and Biological Agency. After the completion of this stage, it is planned to continue the phase 3 clinical trials on children and adolescents aged 9-17. When the results of the last stage of the study are received, the vaccine will be registered on the Russian market.
In 2021, the Russian HPV vaccine successfully passed the first phase of clinical trials, where it showed a more favorable safety profile and better tolerability than the American comparison drug Gardasil®. The trial did not have phase 2, as it is needed for the selection of dosage, which is not required for reproduced vaccines (biosimilars).
The company plans to invest about 2 billion rubles in HPV vaccine development and its full production cycle, including 150 million to be spent on clinical trials by 2023. Another 600 million rubles will be spent on the development and scaling of production technology. The first Russian HPV vaccine will be produced on a full cycle, entirely from domestic raw materials, at Nanolek plant in the Kirov region. The production building has been reconstructed for this purpose.