R-Pharm Group, the Russian Direct Investment Fund (RDIF) and AstraZeneca announce preliminary virus neutralizing activity results of combined use of the AstraZeneca vaccine (developed jointly with the University of Oxford) and the first component of the Sputnik V vaccine (Sputnik Light vaccine based on human adenovirus serotype 26) obtained during the clinical trial in the Republic of Azerbaijan.
Data was collected from the first 20 participants of the study, who had received both components of the combination with AstraZeneca vaccine as the first component and Sputnik Light as the second one administered 29 days later. According to the results of the interim analysis, a fourfold or higher increase in neutralizing antibodies to the spike protein (S-protein) of the SARS-CoV-2 was found in 85% of the volunteers on the 57th day of the study.
The study in Azerbaijan began in February 2021 with 100 volunteers involved to date.
The heterogeneous boosting approach («vaccine cocktail» using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component) was at the core of Sputnik V, the world’s first registered vaccine against coronavirus. With this approach proving successful in creating a longer and more durable immunity against the coronavirus, RDIF took the lead in initiating partnerships with other vaccine producers to conduct joint studies of a combination of the first component of Sputnik V with foreign vaccines.
The first partnership of this kind was concluded in December 2020 in the presence of the President of Russia Vladimir Putin. RDIF, the Gamaleya Center, AstraZeneca and R-Pharm signed a Memorandum of Intent aimed at cooperation in conducting joint clinical trial of safety and immunogenicity of a combination of AstraZeneca COVID-19 vaccine and the first component of Sputnik V.
The interim analysis of data had previously demonstrated antibodies to the SARS-CoV-2 virus spike protein (S-protein) elicited in 100% of volunteers. The combined use of the vaccines has also demonstrated a high safety profile with no serious adverse events or cases of coronavirus infection after vaccination.
Besides Azerbaijan, clinical trials of a combination of the two vaccines are being carried out as part of a global program in UAE and Russia. Regulatory approval to conduct trials has been granted in Belarus.