НИЦЭМ/Цитаты
«In conclusion, these data collectively show that the heterologous vaccine based on rAd26-S and rAd5-S is safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers. The vaccine is highly immunogenic and induces strong humoral and cellular immune responses in 100% of healthy adult volunteers, with antibody titres in vaccinated participants higher than those in convalescent plasma. Unprecedented measures have been taken to develop a COVID-19 vaccine in Russia. Based on our own experience in developing vaccines against Ebola virus disease and MERS, the COVID-19 vaccine has been developed in a short time. Preclinical and clinical studies have been done, which has made it possible to provisionally approve the vaccine under the current Decree of the Government of the Russian Federation of April 3, 2020, no 441 on Aug 11, 2020 (registration no LP-006395 [Gam-COVID-Vac]) and on Aug 26, 2020 (registration no LP-006423 [Gam-COVID-Vac-Lyo]).»
Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia / The LANCET
«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.
The PCR test for SARS-CoV-2 RNA detection at the visit is performed during screening and before the second administration of the vaccine/placebo
Each subject will participate in the trial for 180±14 days after the first dose of the study drug/placebo and will have one screening visit and five on-site visits to the study physician during the said period. The study drug/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 0 and day 21±2). Subsequent observation visits 3, 4, and 5 will be made on days14±2, 28±2, 35±2,42±2, and 180±14 respectively. During the observation visits, vital signs will be assessed in all trial subjects and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Observation visits may be remote, through the telemedicine consultation (TMC).
Additionally, the trial subjects will be able to have remote consultations with the physician through the TMC.
Blood samples will be taken from certain subjects during the following visits to assess the immunogenicity parameters listed below:
Virus-neutralizing activity (300 subjects) ×3 Interferon gamma (107 subjects) ×3 CD4 and CD8 cell count and ratio (50 subjects) SARS-CoV-2 glycoprotein-specific antibodies titer (9,520 subjects) ×3 Determination of the titer of SARS-CoV-2 nucleocleocapsid protein-specific antibodies(9,520 subjects) ×3
Blood sampling will be performed on the day of injecting the first dose of the study drug/placebo immediately prior to the study drug administration Blood sampling for immunogenicity parameters assessment will be only carried out in specially selected study centers.
Blood samples will be taken from 9,520 trial subjects. All four immunogenicity parameters may be assessed in one trial subject.
Trial subjects data will be collected using electronic case report forms and electronic questionnaires to be filled by trial subjects.»
Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST) / U.S. National Library of Medicine clinicaltrials.gov
«Пострегистрационные клинические исследования вакцины Спутник V с привлечением более 40 тыс. человек были запущены в России и Беларуси 25 августа 2020 года. К исследованиям также присоединится ряд стран, среди которых ОАЭ, Индия, Венесуэла, Египет и Бразилия. Вакцина получила свидетельство о регистрации от Минздрава России 11 августа, и в соответствии с правилами, принятыми во время пандемии, может использоваться для вакцинации населения в России. Планируется увеличение производства вакцины в России и во всем мире.»
Клинические испытания / НИЦЭМ
«Фаза 1 и 2 клинических испытаний вакцины были завершены 1 августа 2020 года. Все добровольцы хорошо перенесли испытания, не было зарегистрировано непредвиденных и серьезных нежелательных явлений, вакцина индуцировала формирование высокого как антительного, так и клеточного иммунного ответа. Ни один участник нынешнего клинического испытания не заразился коронавирусом после введения вакцины. Высокая эффективность вакцины была подтверждена высокоточными тестами на антитела в сыворотках крови добровольцев (в том числе проводили анализ на антитела, которые нейтрализуют коронавирус), а также способностью иммунных клеток добровольцев активироваться в ответ на S белок шипа коронавируса, что говорит о формировании и антительного и клеточного иммунного ответа в результате вакцинации.»
Клинические испытания / НИЦЭМ
«При такой скорости разработки и прохождения испытаний вакцин-кандидатов против COVID-19 остается открытым вопрос оценки отдаленных последствий вакцинации, пока неясна длительность сохранения иммунного ответа на прививку и будет ли этот ответ «защитным». Ключевой вопрос насколько хорошо вакцина блокирует инфекцию, на настоящий момент в клинических испытаниях получены лишь данные относительно уровня антительного ответа [25]. До конца не решен вопрос с оценкой ADE-феномена, распространенного при применении целого ряда других противовирусных вакцин [26].»
Состояние проблемы разработки вакцин для специфической профилактики COVID-19 / COVID-19. COVID19-PREPRINTS.MICROBE.RU
«An open two stage non-randomized Phase 1 study with the participation of healthy volunteers. This clinical trial is an open study of safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, with the participation of healthy volunteers. Study objectives
A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using single dose of each component (Stage 1).
A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2).
Study Design Stage 1 the First group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 1 in a full therapeutic dose.
the Second group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 2 in the full therapeutic dose.
The studied drugs will be administered to a total of 18 volunteers in a hospital setting and after administration, the drug's safety will be continuously monitored for 5 days. Based on the results of the safety assessment, the Chief investigator decides to proceed to the second stage of the study on the 5th day after the introduction of the studied drugs.
Second stage The second stage will include 20 volunteers and three understudies. Volunteers of the second stage will be vaccinated no earlier than 5 days after vaccination of participants of the first stage.
Volunteers participating in the second stage of the study (a total of 20 people) will receive the study drug according to the booster scheme: the introduction of component 1 will be carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried out during 4 visits: on 7, 14, 28, 42 days after administration of the drug.
Throughout the inpatient observation and the follow-up period (180 days) of visits during the entire study, safety information will be collected»
An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19 / U.S. National Library of Medicine clinicaltrials.gov
«An open two stage non-randomized Phase 1 study with the participation of healthy volunteers. This clinical trial is an open study of safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac ", ly solution for intramuscular administration, with the participation of healthy volunteers.
Stage one
the First group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 1 in a full therapeutic dose. the Second group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 2 in the full therapeutic dose. The studied drugs will be administered to a total of 18 volunteers in a hospital setting and after administration, the drug's safety will be continuously monitored for 5 days. Based on the results of the safety assessment, the Chief investigator decides to proceed to the second stage of the study on the 5th day after the introduction of the studied drugs.
Second stage The second stage will include 20 volunteers and three understudies. Volunteers of the second stage will be vaccinated no earlier than 5 days after vaccination of participants of the first stage.
Volunteers participating in the second stage of the study (a total of 20 people) will receive the study drug according to the booster scheme: the introduction of component 1 will be carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried out during 4 visits: on 7, 14, 28, 42 days after administration of the drug, and phone calls at days 90 and 180
Throughout the inpatient observation and the follow-up period of visits during the entire study, safety information will be collected»
An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" Vaccine Against COVID-19 / U.S. National Library of Medicine clinicaltrials.gov