Adenoviral vectors are considered extremely safe, and are some of the easiest to engineer. Vectors are viruses that have had the gene responsible for replication removed. Therefore, they no longer pose any threat of infection. Scientists use vectors to transport genetic material from a different virus -the one that is being vaccinated against -into a human cell.
Adenoviruses, which are found in adenoids and regularly cause acute respiratory infections, have become the viruses that are most commonly used to engineer vectors. More than 350 scientific studies have been done and published in various sources around the world concerning the creation of adenovirus vectors.
Selected examples of articles on the safety of human adenovirus vectors (77 articles)
More than 20,000 people around the world have participated in clinical trials on drugs that use adenovirus vectors.
List of clinical trials on human adenovirus-based vector vaccines
Human adenovirus-based drugs have been widely used for more than 50 years.
One drug to help treat cancer tumors in China was approved for use among the civilian population, and has already been given to more than 30,000 patients.
Scientists from the Gamaleya Center have been working on adenoviral vector-based vaccines since the 1980s, and now lead the world in developing these types of vaccines.
Another adenoviral vector-based vaccine against Middle East Respiratory Syndrome (MERS) is in the advanced stages of clinical trials. Many other COVID-19 vaccine candidates also do use adenoviral vectors, but none uses the two-vector platform developed by the Gamaleya Center.
During the vaccine creation process, a gene with the code of a coronavirus S (spike) protein is inserted into an adenoviral vector. This inserted component is safe for the human body, but still helps the immune system to react and produce the antibodies that protect us from infection.
Using adenovirus vectors, scientists at the Gamaleya Center successfully created, and were issued the Russian Federation Ministry of Healthcare certificate of registration for, a vaccine against the Ebola fever that incorporates adenovirus vectors.
Below, you will find the links to the white papers and scientific publications that validate the N.F. Gamaleya Center’s vaccines against the Ebola fever and Middle East Respiratory Syndrome (MERS).
1. Gamaleya EBOLA vaccine
Clinical trial:
International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
International patents:
International patent WO2016130047A1 Immunobiological drug and method for using same for inducing specific immunity against the Ebola virus
Russian Health Ministry registration certificates:
GamEvac-Combi is a multivalent vector-based Ebola vaccine
GamEvac-Lyo is a multivalent vector-based Ebola vaccine
GamEvac is a vector-based Ebola vaccine
Scientific publications:
Dolzhikova IV, Zubkova OV, Tukhvatulin AI, et al. Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia. Hum Vaccin Immunother. 2017
Dolzhikova IV, Tokarskaya EA, Dzharullaeva AS, et al. Virus-Vectored Ebola Vaccines. Acta Naturae. 2017.
Useful links:
Extract from Global Advisory Committee on Vaccine Safety meeting on 5-6 June 2019, published in the World Health Organization Weekly Epidemiological Record of 12 July 2019
Russian Foreign Ministry press release on the post-registration clinical trials of the Russian Ebola vaccine Gam Evac Combi in Guinea.
Russia and Rusal complete Ebola vaccinations in Guinea. Pharmaceutical Technology.
2. Gamaleya MERS vaccine
Study of Safety and Immunogenicity of BVRS-GamVac
Study of Safety and Immunogenicity of BVRS-GamVac-Combi
Ozharovskaia TA, Zubkova OV, Dolzhikova IV, et al. Immunogenicity of Different Forms of Middle East Respiratory Syndrome S Glycoprotein. Acta Naturae. 2019;11(1):38-47.
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