Country for PR: United Kingdom
Contributor: PR Newswire Europe
Monday, February 14 2022 - 19:00
AsiaNet
Clinical trials in Russia and Azerbaijan demonstrated safety of AstraZeneca and Sputnik Light vaccines combination
MOSCOW, Feb. 14, 2022 /PRNewswire-AsiaNet/ --

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.

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

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Source: The Russian Direct Invest Fund (RDIF)