Sputnik Light Vaccines Combination Clinical Trial Update: R-Pharm Group, the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) 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 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 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.
Vasily Ignatiev, CEO of R-Pharm Group: 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.
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.
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 the growing healthcare system’s needs to vaccinate population across the world».
About COVID-19 vaccine AstraZeneca
The vaccine was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
[i] World Health Organization. (2021). Interim recommendations for heterologous COVID-19 vaccine schedules: interim guidance, 16 December 2021