Examining Side Effects of the Sputnik V COVID-19 Vaccine

Background: As a result of the COVID-19 pandemic, many vaccines were developed to counter the disease, including the vector-based Sputnik V vaccine. This study aims to identify the side effects of the Sputnik V COVID-19 vaccine in a medical center and compare the results with the previous reports. Methods: A questionnaire-based study was performed after the injection of the first and second doses of the vaccine to assess the side effects experienced by the participants. It was performed by reviewing similar previous studies. Results: Injection site pain, muscle pain, fever, fatigue, chills, and headache were the most common side effects of the vaccine. The incidence of major side effects decreased with age and was lower in men. In our study and others, the incidence of side effects was decreased in the second dose. In some studies, participants with a previous history of Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCOV-2) infection developed more side effects, especially injection site pain, muscle pain, and fatigue. Conclusion: Most studies agree with our reported results. Serious side effects of this vaccine are rare and may be considered tolerable in adults.

Examining Side Effects of the Sputnik V COVID-19 Vaccine

Background: As a result of the COVID-19 pandemic, many vaccines were developed to counter the disease, including the vector-based Sputnik V vaccine. This study aims to identify the side effects of the Sputnik V COVID-19 vaccine in a medical center and compare the results with the previous reports. Method(s): A questionnaire-based study was performed after the injection of the first and second doses of the vaccine to assess the side effects experienced by the participants. It was performed by reviewing similar previous studies. Result(s): Injection site pain, muscle pain, fever, fatigue, chills, and headache were the most common side effects of the vaccine. The incidence of major side effects decreased with age and was lower in men. In our study and others, the incidence of side effects was decreased in the second dose. In some studies, participants with a previous history of Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCOV-2) infection developed more side effects, especially injection site pain, muscle pain, and fatigue. Conclusion(s): Most studies agree with our reported results. Serious side effects of this vaccine are rare and may be considered tolerable in adults. Copyright © 2022 Shahid Beheshti University of Medical Sciences. All rights reserved.

Functional Profiling of In Vitro Reactivated Memory B Cells Following Natural SARS-CoV-2 Infection and Gam-COVID-Vac Vaccination.

Both SARS-CoV-2 infection and vaccination have previously been demonstrated to elicit robust, yet somewhat limited immunity against the evolving variants of SARS-CoV-2. Nevertheless, reports performing side-by-side comparison of immune responses following infection vs. vaccination have been relatively scarce. The aim of this study was to compare B-cell response to adenovirus-vectored vaccination in SARS-CoV-2-naive individuals with that observed in the COVID-19 convalescent patients six months after the first encounter with the viral antigens. We set out to use a single analytical platform and performed comprehensive analysis of serum levels of receptor binding domain (RBD)-specific and virus-neutralizing antibodies, frequencies of RBD-binding circulating memory B cells (MBCs), MBC-derived antibody-secreting cells, as well as RBD-specific and virus-neutralizing activity of MBC-derived antibodies after Gam-COVID-Vac (Sputnik V) vaccination and/or natural SARS-CoV-2 infection. Overall, natural immunity was superior to Gam-COVID-Vac vaccination. The levels of neutralizing MBC-derived antibodies in the convalescent patients turned out to be significantly higher than those found following vaccination. Our results suggest that after six months, SARS-CoV-2-specific MBC immunity is more robust in COVID-19 convalescent patients than in Gam-COVID-Vac recipients. Collectively, our data unambiguously indicate that natural immunity outperforms Gam-COVID-Vac-induced immunity six months following recovery/vaccination, which should inform healthcare and vaccination decisions.

THE FREQUENCY OF CLASS G IMMUNOGLOBULINS ' FORMATION TO THE SARS-CoV-2 CORONAVIRUS IN IMMUNIZATION OF HIV-INFECTED PATIENTS WITH Gam-COVID-Vac VACCINE AND THE REACTOGENICITY OF THE VACCINE

The research aimed to study the frequency of class G antibodies' formation to SARS-CoV-2 in HIV-infected patients in response to immunization with the Gam-COVID-Vac vaccine and the reactogenicity of the vaccine. Materials and methods. 36 HIV-infected and 38 HIV-negative volunteers were vaccinated. The inclusion criteria for patients were: age 18 years and older;absence of earlier disease COVID-19;negative test of the presence of RNA in a smear from the nasopharyngeal and oropharyngeal mucosa and IgG in blood serum to SARS-CoV-2, absence of contraindications, undetectable viral load. The number of CD4+ lymphocytes in the blood of HIV-infected people before vaccination was 520,0±9,6. It was used the two-dose vaccine Gam-COVID-Vac, developed by National Research Center named after N.F. Gamaliel. The interval between the administration of the vaccine was 24,2±0,5 days. The presence of IgG before vaccination and 44-54±0,6 days after the start of vaccination to SARS-CoV-2 coronavirus was determined by enzyme immunoassay using the SARS-CoV-2-RBD-ELISA-Gamaleya test system. The positivity index (PI) was calculated for each test sample. The sample was considered positive at IP>1. Results. The presence of antibodies in HIV-infected patients was detected in 75,0% cases, in HIV-negative — in 92,1% cases, the arithmetic average of the positivity index was 10,3±1,9 in the observation group, 15,3±1,9 in the comparison group (χ2=3,9;p=0,04). There are no postvaccinal complications registered in patients of both groups. The frequency of general reactions to the introduction of the first and (or) second components of the vaccine in the group of HIV-infected and HIV-negative did not differ and amounted to 8,3 and 13,2%, respectively. Local reactions among HIV-infected (in 19,4% of cases) were less common than among HIV-negative (in 47,4% of cases) (χ2=6,4;p=0,01). Conclusion. Humoral immunity in response to immunization of Gam-COVID-Vac against SARS-CoV-2 in HIV-infected with minor immunosuppression is less pronounced than in HIV-negative. However, the production of postvaccinal class G immunoglobulins in HIV-infected patients in 75,0% of cases and the weak reactogenicity of the vaccine it is recommended for using in people living with HIV on the back of effective antiretroviral therapy. © 2021. All Rights Reserved.

Effectiveness of Gam-COVID-Vac vaccine in the Khabarovsk region from october 2020 to june 2021 based on registers data

Mass immunization of the population is a fundamental measure to prevent the spread of infection caused by the SARS-CoV-2 virus. Published Russian and foreign data demonstrate the high effectiveness of the Russian Gam-COVID-Vac vaccine. However, the effectiveness of the vaccine against new coronavirus COVID-19 (hereinafter referred to as NCV) at the population level in Khabarovsk region has not been previously studied. Objective. To analyze the effectiveness of the Gam-COVID-Vac vaccine in real-world practice in healthcare institutions of Khabarovsk region to prevent symptomatic cases of NCI. Material and methods. A comprehensive data analysis was performed on 154,144 records from the regional segment of the Federal registry of COVID-19 vaccinated population compared to 55,578 records in the regional segment of the Federal registry of COVID-19 infected population. During the study, parametric and nonparametric methods were used, relative and mean values and their errors were calculated, and significance was determined using MS-Office 2017 and Statistica 10.0 software. The values were considered significant at p<0.05. The calculations were made taking into account the adult population of Khabarovsk region. Results. Immunization results of 154,144 subjects were studied, 88,324 (57.30±0.13%) were over 50 years old. A total of 145,270 (94.24±0.06%) subjects were fully vaccinated, 751 (0.49%) of them became infected. The maximum incidence values (200.00±40.00 ‰) were recorded in those over 50 years old who received only the first vaccine component more than six months ago, while the minimum values were recorded in those under 50 years old who received both vaccine components (2.04±0.17‰). In those vaccinated, who got infected with NCI, 83.0% had a mild disease;in 17.0%, a moderate severity course with lung damage was registered, which was considered CT grade 2 in 29.4% of cases, and CT grade 1 in 70.6% of cases. The effectiveness of the Gam-COVID-Vac vaccine to prevent symptomatic NCI was 98.4%, and 100.0% to prevent the severe course of the disease and death. In addition, the use of the vaccine in Khabarovsk region from October 1, 2020 to June 30, 2021 (a total of 15.1% of the adult population of the region was vaccinated) resulted in a 10-fold reduction in the incidence of NCI. Conclusion. The effectiveness of Gam-COVID-Vac vaccine in real-world practice is demonstrated. Broader vaccination of the Khabarovsk region population will further reduce the incidence of NCI in the region. (English) [ FROM AUTHOR] Массовая иммунизация населения является одной из основополагающих мер по предупреждению распространения инфекции, вызываемой вирусом SARS-CoV-2. Опубликованные данные российских и зарубежных ученых демонстрируют высокую эффективность российской вакцины Гам-КОВИД-Вак. Однако исследования эффективности использования вакцины против новой коронавирусной инфекции COVID-19 (далее НКИ) на популяционном уровне в Хабаровском крае ранее не проводились. Цель исследования. Анализ эффективности применения вакцины Гам-КОВИД-Вак в реальной клинической практике в учреждениях здравоохранения Хабаровского края по предотвращению симптомных случаев НКИ. Материал и методы. Проведен комплексный анализ данных 154 144 записей регионального сегмента Федерального регистра вакцинированных от COVID-19 в сопоставлении с 55 578 записями в региональном сегменте Федерального регистра лиц, больных COVID-19. Ð’ ходе исследования применяли параметрические и непараметрические методы, проводили расчетотносительных и средних показателей и их ошибок, достоверность определяли с использованием пакета прикладных программ MS-Office 2017 и Statistica 10.0. Показатели считали à ´Ð¾ÑÑ‚Ð¾Ð²ÐµÑ€Ð½Ñ‹Ð¼Ð¸ при p<0,05. Расчеты проводили с учетом численности взрослого населения Хабаровского края. Результаты. Изучены результаты иммунизации 154 144 человек, из них 88 324 (57,30±0,13%) относились к возрастной группе старше 50 лет. Полный курс вакцинации получили 145 270 (94,24±0,06%) человек, из них заболел 751 человек (0,49% от когорты вакцинированных). Максимальные значения заболеваемости (200,00±40,00‰) отмечены среди лиц старше 50 лет, получивших только первый компонент вакцины более 6 мес назад, тогда как минимальные значения зарегистрированы среди лиц моложе 50 лет, получивших первый и второй компонент вакцины (2,04±0,17‰). Среди вакцинированных, заболевших НКИ, у 83,0% пациентов заболевание протекало в легкой форме;в 17,0% случаев регистрировалось среднетяжелое течение с развитием поражения легких, которое в 29,4% случаев расценивалось как КТ-2, а в 70,6% - как КТ-1. Эффективность вакцины Гам-КОВИД-Вак для профилактики симптомной НКИ составила 98,4%, для предупреждения тяжелого течения заболевания и развития летальных исходов - 100,0%. Кроме того, применение в Хабаровском крае вакцины с 01 октября 2020 г. по 30 июня 2021 г. Ð²ÐºÐ»ÑŽÑ‡Ð¸Ñ ÐµÐ»ÑŒÐ½Ð¾ (всего вакцинировано 15,1% взрослого населения края) продемонѠтрировало снижение заболеваемости НКИ в 10 раз. Выводы. Показана эффективность вакцины Гам-КОВИД-Вак в реальной клинической практике. Несомненно, что более широкий охват вакцинацией населения Хабаровского края будет способствовать дальнейшему снижению заболеваемости НКИ в крае. (Russian) [ FROM AUTHOR] Copyright of Profilakticheskaya Meditsina is the property of Media Sphere Publishing House and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Safety and preliminary efficacy of the Gam-COVID-Vac vaccine and outcomes of SARS-CoV-2 infection in Russian patients with genitourinary malignancies.

BACKGROUND: To our knowledge, there is no clinical data pertaining to COVID-19 outcomes and safety of COVID-19 vaccination in Russian patients with genitourinary (GU) malignancies. Aim of our analysis was to describe the characteristics of the COVID-19 infection course as well as preliminary safety and efficacy of Gam-COVID-Vac vaccine in patients with active GU malignancies. METHODS: Patients were retrospectively identified at nine cancer centers in different regions. Patients were included if COVID-19 was diagnosed by a polymerase chain reaction. Data from additional patients with GU cancers who had no positive SARS-CoV-2 RT-PCR test before vaccination and who received two doses of Gam-COVID-Vac (Sputnik V) between 11 February and 31 August 2021 were collected for safety assessment. Anonymized data were collected through an online registry covering demographics, treatments, and outcomes. RESULTS: The Gam-COVID-Vac vaccine was well tolerated; no grade 3-5 toxicities were reported in 112 vaccinated metastatic GU cancer patients. The most common grade 1 adverse events (81%) were injection site reactions (76%), flu-like illness (68%), and asthenia (49%). Five patients experienced grade 2 chills (4.5%) and 3 patients had grade 2 fever (2.7%). With median follow-up of 6.2 months, two COVID-19 cases were confirmed by RT-PCR test in the vaccine group (of 112 participants; 1.8%). Eighty-eight patients with COVID-19 disease were included in the analysis. The average age as of the study enrollment was 66 (range 39-81) and the majority of patients were male with renal cell carcinoma (RCC). Thirty-six patients (41%) had evidence of metastatic disease, of these 22 patients were receiving systemic therapy. More than half of patients required hospitalization. Fifty-four patients (61%) experienced complications. Sixteen patients who developed COVID-19 pneumonia required mechanical ventilator support. Sixteen patients (18%) died in a median of 23.5 days after the date of COVID-19 diagnosis was established. The 3-month survival rate was 82%. Clinical and/or radiographic progression of cancer during COVID-19 infection or the subsequent 3 months was observed in 10 patients (11.4%). CONCLUSION: Patients with GU malignancies are at increased risk of mortality from COVID-19 infection when compared to the general population. Vaccination could be safe in GU cancer patients. TRIAL REGISTRATION: retrospectively registered.