The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and the Gamaleya National Research Institute of Epidemiology and Microbiology have launched an information section about the human adenovirus vaccine platform on the website of the world’s first registered vaccine against coronavirus, “Sputnik V”, at: sputnikvaccine.com
The section contains links to scientific publications on the history of vaccines based on human adenoviruses and human adenoviral vectors, their clinical trials, the technological platform, the proven safety of this approach, as well as their application in the fight against various diseases.
Next week a previously planned post-registration, randomized, double-blind, placebo-controlled multicenter clinical study of the efficacy, immunogenicity and safety of the Sputnik V vaccine will begin in Russia, simultaneously with the vaccination of volunteers from risk groups. More than 40,000 people will take part in the study in more than 45 medical centers.
A table comparing human adenovirus vaccines with other developments
|Human adenovirus||Chimpanzee adenovirus||mRNA|
|Approved antiviral drugs based on the specified platform||3 vaccines against Ebola: Over 60,000 people vaccinated (African states, China, Russia)||NO||NO|
|Approved cancer drugs based on the specified platform||2 cancer drugs: Over 30,000 people vaccinated (China)||NO||NO|
|Years since the beginning of the mass use of drugs based on this platform||17 years (cancer drugs)||Not in use||Not in use|
|Long-term safety studies (including no risk of carcinogenicity and reduced fertility) of drugs completed or underway||YES||NO||NO|
|Full-scale production track record||YES||NO||NO|
|Number of clinical trials completed in phase 3 – verification of safety, efficacy and therapeutic effect||4||0||0|
|Number of clinical trials on this platform||254||67||165|
|Number of people involved in completed clinical trials||Over 20,000.||Less than 7,000.||Less than 10,000.|
|Number of people potentially involved in upcoming clinical trials||Over 500,000.||Less than 50,000.||Less than 100,000.|
|Number of research papers on each platform||353||134||109|
Clinical trials statistics are based on data from clinicaltrials.gov based on search queries containing platform names human adenoviral vector (Ad5, Ad26, etc.), chimpanzee adenoviral vector (ChAd3, ChAd63, etc.) and mRNA vaccine.
Statistics on research papers are based on pubmed.ncbi.nlm.nih.gov data searched by queries containing platform names.
- Research on human adenoviruses as a potential base for vaccine development began in 1953.
- Vaccines do not contain live human adenoviruses, but human adenovirus vectors, that is, human viruses that cannot multiply in the body and are completely safe.
- More than 20,000 people have taken part in clinical trials of vaccines and drugs based on human adenoviruses or human adenoviral vectors.
- Human adenovirus vaccines have been used most widely by the US Army since 1971 to date. These type of vaccines are offered by the US Armed Forces to recruits. US Food and Drug Administration (FDA) approved human adenovirus vaccines in 2011. More than 10 million US military personnel have received the human adenovirus vaccines.
- An anti-cancer drug based on human adenoviral vectors has been used to treat more than 30,000 patients in China.
- Human adenovirus vaccines proven to have no long-term health risks, including no risk of carcinogenicity and no risk of affecting fertility. Health safety has been proven by more than 75 international publications and in more than 250 clinical trials.
- Other means of delivering viral genetic material to stimulate the body’s immune response, such as monkey adenovirus or mRNA technology, have never been used in approved vaccines before. No long-term studies have been conducted on the possible effects of such technologies for human body, including the possibility of cancer and the effect on fertility.
- The approach of the Gamaleya Institute with the vaccine using two human adenoviruses serotypes: number 5 (Ad5) and number 26 (Ad26) has a clear advantage over the one-vector approach used by other developers.
- Human adenoviral vectors are used in the development of vaccines against coronavirus by the world’s leading pharmaceutical companies. At the same time, their vaccines are single-vector: CanSino (China) uses the Ad5 vector, which has already been approved for use by the Chinese army, Johnson & Johnson (USA) uses the Ad26 vector. Johnson & Johnson has received orders for more than 140 million doses of the drug based on the vector Ad26 from the United States and Europe.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said:
“We get a lot of questions about the vaccine, including the platform on which it was developed. RDIF and the Gamaleya Institute strive for maximum transparency about the details of the vaccine’s development, which is why we post all information about adenovirus vaccines at sputnikvaccine.com. We would like to thank everyone for their interest in “Sputnik V” both in Russia and abroad – the vaccine website has already been visited by representatives of more than 200 countries. We plan to add new content to the site with new details on the vaccine in the future.”