The Russian Direct Investment Fund (RDIF), R-Pharm group, and AstraZeneca announce interim results of phase II clinical trials to evaluate the safety and immunogenicity of the combined use of AstraZeneca's vaccine and the first component of the Sputnik V coronavirus vaccine (Sputnik Lite).

According to the interim results of the trials, involving 100 volunteers in Russia and 100 volunteers in Azerbaijan, the combination of the vaccine demonstrated an acceptable safety profile, which is consistent with the results of the previous AstraZeneca vaccine, Sputnik V and Sputnik Lite vaccines clinical trials.

Volunteers were being monitored for 57 days after the first dose. Monitoring results demonstrated a good safety profile of the combination. No serious adverse events related to vaccination were registered.

The research conducted by RDIF, the Gamaleya Center, AstraZeneca, and R-Pharm is the first study in the world to evaluate the combined use of components of different adenovirus vaccines to prevent coronavirus infection. In December 2021, the World Health Organization (WHO) recommended a similar approach, also known as a heterologous prime booster vaccination. The WHO estimates that the interchangeability of different drugs will allow greater flexibility in vaccination programs, increase vaccine efficacy and affordability.

A joint phase II clinical trial to evaluate the safety and immunogenicity of a combination of AstraZeneca's vaccine and the first component of the Sputnik V vaccine is being conducted under the memorandum signed in December 2020 by the Russian Direct Investment Fund, the Gamaleya Center, AstraZeneca and R-Pharm.

The study takes place in Azerbaijan, Russia, and the United Arab Emirates. Volunteers receive intramuscular injections of the AstraZeneca vaccine and the Ad26-S component of the Sputnik V vaccine in different sequences at 28-day intervals.