New Delhi, February 14, 2022 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), 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 vaccines combination demonstrated an acceptable safety profile, which is consistent with the results of 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 heterologous prime booster vaccination.[i]The WHO estimates that 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.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF): Preliminary data from the trial to test Sputnik Light and AstraZeneca vaccines combination support the “mix and match” approach to revaccination. With new dangerous variants of concern emerging, this approach could provide safe, effective and long-term protection.
Vasily Ignatiev, CEO of the R-Pharm Group JSC: Current safety data adds to the data on the high immunogenicity profile of the vaccine combination that has been announced earlier. We are one step closer to completing the studies. The results are being processed.
Irina Panarina, GM, Russia & Eurasia: The results, obtained in the clinical trials, indicate the safety of vaccine combination. The use of «vaccine cocktails» may be an option in face of growing healthcare system needs to vaccinate population across the world».
About the Sputnik Light vaccine:
Sputnik Light is based on recombinant human adenovirus serotype number 26 (the first component of Sputnik V). A one-shot vaccination regimen of Sputnik Light provides for ease of administration and helps to increase efficacy and duration of other vaccines when used as a booster shot.
Sputnik Light as a booster significantly increases virus-neutralizing activity against Omicron, which is comparable to titers observed after Sputnik V against wild-type virus, associated with high levels of protection. Sputnik Light has been registered in more than 30 countries with total population of over 2.5 billion people. A number of countries, including Argentina, Bahrain, UAE, San Marino and Philippines, have already authorized Sputnik Light as a universal booster.