Gamaleya Research Institute of Russia on August 11 became the first country in the world to have registered a vaccine against the coronavirus - Sputnik V which is Adeno-based Non-replicating viral vector. It is a combination of two adenoviruses, Ad5 and Ad26, both engineered with a coronavirus gene.

“The vaccination of first volunteers as part of Phase 3 clinical trials of Russia’s Sputnik V coronavirus vaccine will begin as early as this week,” Russian Minister of Health Mikhail Murashko told journalists on Monday.

The vaccine was created at the Gamaleya Institute and underwent clinical tests in June-July. It is based on a platform that had already been used to create a number of other vaccines. On August 15, the Health Ministry said the vaccine’s production had been launched.

Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

The trial will include 40,000 volunteers aged 18+. After screening, they will be randomized (3:1) into two groups - a reference group of 10,000 volunteers receiving placebo and a study group of 30,000 volunteers receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection.

The trial subjects will be randomized into five age strata: 18-30, 31-40, 41-50, 51-60, and 60+ years.

First Wave of Vaccinations

The first set of vaccinations will involve what are considered “at-risk” groups such as medical/health care workers, teachers, first responders and others that might encounter those infected more frequently.

Other Notable Developement

The Gamaleya Center successfully developed and registered in 2015 two vector-based vaccines against Ebola fever using the adenovirus vector platform. Another Ebola fever vaccine was registered in 2020. The vaccines have been officially approved for use by the Russian Health Ministry. Аbout 2,000 people in Guinea received injections of Ebola vaccine in 2017-18 as part of Phase 3 clinical trial. Gamaleya Research Center received an international patent for Ebola vaccine.

Gamaleya Research Center used adenoviral vectors to develop vaccines against influenza and against Middle East Respiratory Syndrome (MERS). Both vaccines are currently in advanced stages of clinical trials.

Safety & Efficacy

After the start of the COVID-19 pandemic Russian researchers extracted a fragment of genetic material from novel coronavirus SARS-COV-2, which codes information about the structure of the spike S-protein, which forms the virus’ “crown” and is responsible for connection with human cells. They inserted it into a familiar adenovirus vector for delivery into a human cell creating the world’s first COVID-19 vaccine.

In order to ensure lasting immunity Russian scientists came up with a breakthrough idea to use two different types of adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting the effect of the vaccine.

The use of human adenoviruses as vectors is safe because these viruses, which cause the common cold, are not novel and have been around for thousands of years.

Source:

https://clinicaltrials.gov/ct2/show/NCT04530396

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker

https://covidvax.org/covid19-vaccine/Gamaleya/Adeno-based-Gamaleya-Research-Institute