Preliminary clinical research
editPre-clinical trials
editResearch Institute of Microbiology of the Ministry of Defense conducted preclinical toxicity, safety, protective efficiency, and potency animal trials of the Gam-COVID-Vac. The tests were carried out on two species of mammals: the golden hamsters and two species of primates. Staff members of the research institute applied in-house methodology to the quantification causative agent and a laboratory model for the breeding of severe acute respiratory disease. Scientific studies helped reduce the vaccine preliminary clinical trial time.[1][2][3].
Phases I / II clinical trials for Gam-COVID-Vac
editThis phase of clinical trials is an open-label safety, immunogenicity, and tolerability study of Gam-COVID-Vac. On June 16, 2020, the Russian Ministry of Health issued permission No. 241 to conduct this clinical trial.[4] A Phase I safety trial began on 18 June.[5]
The liquid vaccine efficacy trial was carried out at the Main Military Clinical Hospital named after N.N. Burdenko. The tests involved 38 volunteers. Phase I included safety, immunogenicity, and tolerability tests for each component of the vaccine separately: 18 volunteers divided into two groups were injected with component I or II. Phase II included booster vaccination: 20 people received injections of component I, and 21 days later, — injections of component II. Antibody production test showed high titres of COVID-19 antibodies, volunteers had no serious complications after an immunological challenge.[6].
Phase III clinical trials (post-registration)
editPhase III is a randomized double-blind placebo-controlled multicenter clinical study with the parallel safety, immunogenicity, and efficiency ascertainment. On August 25, 2020, the Russian Ministry of Health issued post-registration permission No. 250 to conduct this clinical trial.[4][7] This clinical trial program was designed for 40,000 volunteers aged 18 and over. After COVID testing, they were randomized into two groups (3: 1) — a group of 30,000 volunteers receiving the combined vector vaccine Gam-COVID-Vac and a 10,000 volunteers placebo arm.[8]
The trial began on August 26, 2020, and involved 25 medical organizations of Moscow. Monitoring volunteers' health should be for 6 months minimum.[9] Therefore, a special mobile application with a self-observation journal was created, some participants received electronic tagging for measuring blood pressure and body temperature.[10] Phase III also included collaboration with international medical centers. For example, Israel Hadassah Medical Center director-general Prof. Zeev Rotstein stated in The Jerusalem Post on November 4, 2020 "Hadassah’s branch in Moscow’s Skolkovo Innovation Center has been collaborating on a Phase III clinical trial... [and it] should be complete in the next month or two. That trial is testing the vaccine on some 40,000 people in Russia and several other countries. Tens of thousands of volunteers have already received the vaccine."[11]
On December 10, 2020, Ramil Khabriev of the Russian National Research Institute of Public Health, claims that the phase III trials of the Spunik V vaccine is "successfully coming to an end".[12] Four days later the Gamaleya Institute published data on 22,714 participants in the phase III trials.[13]
On December 11, 2020, AstraZeneca announced they would start clinical trials to test a combination of its experimental COVID-19 vaccine, AZD1222, with Russia’s Sputnik V. AstraZeneca said it was considering how it could assess combinations of different vaccines, and would soon begin exploring with Gamaleya Research Institute, developer of Sputnik V, whether two vaccines based on a common-cold virus could be successfully combined.[14]
Phase II clinical trials with seniors
editThis phase of clinical trials is an open-label safety, immunogenicity, and tolerability study of Gam-COVID-Vac with volunteers over 60 years of age. On October 13, 2020, the Russian Ministry of Health issued permission No. 566 to conduct this clinical trial. The study involved 110 people.[4][15]
References
edit- ^ "Вакцина НИЦ Гамалеи и Минобороны помогла выработать антитела к коронавирусу". Vedomosti (in Russian). July 7, 2020. Archived from the original on 2020-10-15. Retrieved 2020-11-21.
- ^ "Прививка от коронавируса будет как обычный укол и даст защиту на год" (in Russian). Komsomolskaya Pravda. July 8, 2020. Retrieved 2020-07-18.
- ^ "Клинические испытания". sputnikvaccine.com (in Russian). December 12, 2020. Retrieved 2020-12-12.
- ^ a b c "Реестр разрешений на проведение клинических исследований (РКИ)". grls.rosminzdrav.ru (in Russian). Ministry of Health. December 12, 2020. Retrieved 2020-12-12.
- ^ Cite error: The named reference
naturewas invoked but never defined (see the help page). - ^ "Study "Gam-COVID-Vac" Vaccine Against COVID-19". ClinicalTrials.gov. Health Ministry of the Russian Federation. August 12, 2020. Retrieved 2020-08-12.
- ^ "Минздрав России выдал Центру Гамалеи разрешение на проведение пострегистрационного клинического исследования вакцины от коронавируса" (in Russian). Health Ministry of the Russian Federation. December 25, 2020. Retrieved 2020-12-20.
- ^ "Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST)". ClinicalTrials.gov. Health Ministry of the Russian Federation. October 20, 2020. Retrieved 2020-10-20.
- ^ "Москвичи могут принять участие в пострегистрационных исследованиях вакцины от коронавируса". www.mos.ru (in Russian). Official site of the Mayor of Moscow. August 26, 2020. Retrieved 2020-08-26.
- ^ "Клиническое исследование вакцины". www.mos.ru (in Russian). Official site of the Mayor of Moscow. August 26, 2020. Retrieved 2020-08-26.
- ^ "Hadassah bringing 1.5 million doses of Russian COVID-19 vaccine to Israel". The Jerusalem Post | JPost.com. Retrieved 2020-11-19.
- ^ "Covid vaccine Sputnik V,s phase II trials ends successfully". United News of India. December 10, 2020.
- ^ "The Sputnik V vaccine's efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials". sputnikvaccine.com. Retrieved 2020-12-18.
- ^ Osborn, Andrew; Aripaka, Pushkala; Burger, Ludwig; Mason, Josephine (11 December 2020). Graham, Patrick (ed.). "AstraZeneca hitches ride with Russia's Sputnik in vaccine race". Reuters. Mark Potter and Kevin Liffey (ed.).
- ^ "The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older". ClinicalTrials.gov. Health Ministry of the Russian Federation. October 10, 2020. Retrieved 2020-12-12.