Rokote Laboratories Finland Oy Submits First Clinical Trial Application

The development of the nasal COVID-19 vaccine by the Finnish vaccine development company Rokote Laboratories Finland Oy has successfully progressed to the stage where the company has submitted an application for its first clinical trial.
 
Rokote Laboratories Finland Oy is developing a Finnish nasal COVID-19 vaccine. The company now has sufficient research and development data on the vaccine, as well as data on its efficacy and safety, to apply for approval to test it on humans for the first time.
 
"The application for the first clinical trial has now been submitted, which means the vaccine has performed as expected in all non-clinical studies conducted so far," says Erkko Ylösmäki, CEO of Rokote Laboratories Finland Oy.
 
The evaluation of the clinical trial application and the trial itself will be conducted in Finland
 
The clinical trial application is a comprehensive document package that presents the authorities with the objectives of the trial, selection criteria for subjects, research methods, and evaluation criteria. The application also includes detailed information about the vaccine being studied, such as its composition, manufacturing and quality control processes, as well as data from preclinical studies where the vaccine’s effects were studied in laboratory and animal models.
 
"The clinical trial can begin once the authorities have evaluated and approved the application. The clinical trial will be conducted in Finland, so the application will be evaluated by the Finnish Medicines Agency (Fimea) and the National Committee on Medical Research Ethics  (Tukija)," explains Ylösmäki.
 
The duration of the application evaluation process varies depending on whether additional clarifications are needed. It is estimated that Rokote Laboratories Finland Oy can start the clinical trial by the end of 2024.
 
The first trial will investigate the vaccine's immunogenicity, safety, administration method, and dose level
 
The objective of the first clinical trial is to determine whether the new vaccine can produce antibodies against the SARS-CoV-2 virus and to ensure that the vaccine is safe for users. The trial will determine the appropriate dose level of the vaccine and explore whether the best method of administration for the nasal vaccine is a spray or drops. The vaccine will be administered to healthy volunteers aged 18–75.
 
"In addition to those who have already been vaccinated, we also want to include unvaccinated individuals, i.e. those who have not yet received any COVID-19 vaccination," says clinical trial manager Katriina Lavikainen
 
The efficacy of the vaccine will be studied in separate later trials, in the second and third phases of the clinical trial.
 
Ongoing need for COVID-19 vaccines – likely annually
 
According to the Finnish Institute for Health and Welfare (THL), the coronavirus will continue to be present globally, and we will see recurring epidemics according to seasonal variation.
 
"The coronavirus, like the influenza virus, is here to stay, and it now seems likely that at least the risk groups will be vaccinated annually. This means that there will continue to be a need for COVID-19 vaccines," says Erkko Ylösmäki.
 
Rokote Laboratories Finland Oy is one of the few European companies developing a nasal COVID-19 vaccine.
 
"A nasal vaccine has many advantages over current vaccines. We can create a strong immune defense on the mucous membranes of the nasopharynx, preventing the virus from attaching and multiplying, thereby avoiding the disease. Additionally, not everyone prefers injections, and we provide a solution for that. In the future, it may even be possible for individuals to self-administer the nasal vaccine."
 
Developed Technology Offers Rapid Response to New Variants
 
Rokote Laboratories Finland Oy is developing a second-generation coronavirus vaccine aimed at providing strong protection against the rapidly mutating variants of the virus. The goal of the clinical trial is also to verify the functionality of the vaccine technology used.
 
"Once we verify the effectiveness of our vaccine technology, we can quickly develop new vaccines in the future, even against yet unknown viruses," Ylösmäki says.

​Text: Anni Turpeinen