Russia has joined the ranks of COVID-19 vaccine developers exploring nasal delivery. Having originally developed Sputnik V for intramuscular administration, Russian researchers are now set to study the effects of giving two doses to volunteers via nasal delivery—if they can get funding for the trial.
Advocates of delivering COVID-19 vaccines via nasal sprays highlight the ease of administration and potential to increase antibody levels in nasal passages, where the virus first takes root, as benefits over intramuscular shots. The potential benefits have attracted a small group of vaccine developers, including the University of Oxford team behind the AstraZeneca COVID-19 jab.
Now, the developers of Russia’s Sputnik V vaccine have joined the race. An update to the Russian clinical trial registry, which was picked up by the TASS news agency, shows researchers will test a nasal spray in a midphase study.
The clinical trial will assess the safety, tolerability and immunogenicity of two 0.5-ml doses of Sputnik V when delivered through the nose. The end date of the study is listed as December 2023, and the enrollment target is set at 500 volunteers. A typical phase 2 study could have useful data well before the end of 2023, but the Russian developers are yet to share any interim timelines or targets.
While researchers at Russia’s Gamaleya Center now have clearance to run the study, they are yet to start the clinical trial because of a lack of financing, according to TASS. The news agency posted the update after talking to Alexander Gintsburg, the Gamaleya Center’s director. Gintsburg has previously said the nasal spray formulation may receive certification next year.
The timeline suggests the center could be among the first groups to bring a COVID-19 nasal spray vaccine to market. According to the World Health Organization, there are eight nasal spray vaccines in development, representing 6% of all candidates.