PR94520

MOSCOW, Feb. 14, 2022 /PRNewswire=KYODO JBN/ --

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)