Rokote Laboratories Finland Oy is starting the first clinical drug trial with its nasal COVID-19 vaccine. The vaccine has been developed and manufactured in Finland, and the study will be conducted at Kuopio University Hospital starting January 21, 2025.
The second-generation COVID-19 vaccine developed by Rokote Laboratories Finland Oy is innovative in both its technology and administration method compared to the COVID-19 vaccines currently on the market. The vaccine is administered nasally, aiming to create a strong immune defense against the coronavirus, thereby preventing the virus from attaching and multiplying, and ultimately preventing the disease. The development of the vaccine began in 2020, and it is now ready for the first clinical trial in humans. “We submitted the application for the Phase I clinical trial to the Finnish Medicines Agency Fimea and the National Medical Ethics Committee in July. The authorities have now reviewed the application and granted permission to start the study,” says Professor Seppo Ylä-Herttuala, Chairman of the Board and Medical Director of the upcoming study. Phase I Will Investigate Immunogenicity, Safety, and Administration Method The goal of the study starting in January is to determine whether the new vaccine generates sufficient antibodies against the SARS-CoV-2 virus and its variants, and to ensure the vaccine’s safety. The study will determine the appropriate dosage level of the vaccine and explore whether the best method of nasal administration is a spray or drops. The vaccine will be administered to healthy volunteers aged 18-75. The study will last approximately four months, after which the results will be reported to Fimea. “The most important measure is the baseline and outcome level of antibodies after one month. The goal is for antibody levels to at least double. The vaccine has been developed against several coronavirus variants, and the antibody levels for all variants should rise,” says lead researcher Professor Emeritus Heikki Löppönen from Kuopio University Hospital. Nasal Administration Enables Wide Population Vaccinations with Fewer Resources The nasal vaccine developed by Rokote Laboratories is designed to suppress infection before symptoms arise, thereby preventing virus transmission. An advantage of nasal administration is its ease. A nasal vaccine would enable wide population vaccinations easily and with fewer resources. “The coronavirus will not disappear from the world, and there are still hundreds of thousands of people to be vaccinated in Finland, and even more in Europe and the world. Aging is one of the risk factors for COVID-19, as well as diabetes, smoking, and being male over 65 years old. Risk groups also include patients with severe infections and immunodeficiency diseases,” says Heikki Löppönen. Technology Adaptable for Future Pandemics During the development of the vaccine Rokote Laboratories has taken into account that the vaccine can be tested and adapted for potential future pandemics. If the coronavirus mutates to become more dangerous and poses a serious health threat, the vaccine technology allows for a rapid response. The technology can also be applied to other known and yet unknown viruses. “In recent years, Finland has not had its own vaccine production, and we have therefore not been very self-sufficient in terms of vaccines. If our vaccine succeeds in future studies, we will be one step closer to self-sufficiency,” says Erkko Ylösmäki, CEO of the company. Further information: Seppo Ylä-Herttuala (MD, PhD, Professor) Chairman of the Board Rokote Laboratories Finland Ltd [email protected] +358 40 355 2075 Heikki Löppönen (MD, PhD, Professor Emeritus) Lead Researcher Kuopio University Hospital [email protected] p. +358 40 5656 183 Erkko Ylösmäki (PhD, Adj. Professor) CEO Rokote Laboratories Finland Ltd [email protected] +358 40 583 6604 Text: Anni Turpeinen
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