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BackgroundDuring the COVID-19 pandemic, adenoviral vector-based Sputnik V vaccine was used to vaccinate the civilian population of 74 countries worldwide. As part of laboratory monitoring of the effectiveness of the Sputnik V vaccine, a decrease in effectiveness was detected against Omicron BA.5 and XBB variants. XBB variant quickly displaced all previously circulating variants, so the antigen composition of the Sputnik V vaccine was changed to the XBB variant.MethodsThe Gam-COVID-Vac XBB (Sputnik V XBB) vaccine was developed, manufactured, and stored by Gamaleya NRCEM (Moscow, Russia). Two open prospective clinical study of the safety, reactogenicity and immunogenicity of the Sputnik V XBB vaccine was conducted in 50 adult participants over 18 years old and 50 adolescent participants 12–17 years old (ClinicalTrials.gov Identifier: NCT06068569 and NCT06068556). Immunogenicity study included ELISA assay for detection glycoprotein S of the Omicron XBB variant and neutralization assay with viable SARS-CoV-2 virus Omicron ХВВ.1.5, ХВВ.1.9.1, ХВВ.1.16, EG.5.1, ВА.2.86, JN.1, KS.1, XFG.3, NY.2 and PY.2 variants.ResultsSafety profile of the Sputnik V XBB vaccine was consistent with the previous formulation, and no new safety concerns were reported. There were no cases of serious AEs. Seroconversion of antigen-specific IgG on day 42 was 100% in adults and 87.5% in adolescents. We showed robust NtAb response to circulating SARS-CoV-2 variants (ХВВ.1.5, ХВВ.1.9.1, ХВВ.1.16, EG.5.1, ВА.2.86, JN.1, KS.1, XFG.3, NY.2 and PY.2) in vaccinated adults and adolescents, seroconversion rate of NtAb against any circulating variant was 96% in adults and 94% in adolescents.ConclusionThe results of the clinical trials demonstrated a favorable safety profile and a high level of immunogenicity of Sputnik V XBB in adults and adolescents.Clinical Trial RegistrationClinicalTrials.gov, identifiers NCT06068569 and NCT06068556.

Since the beginning of the 2021 year, all the main six vaccines against COVID-19 have been used in mass vaccination companies around the world. Virus neutralization and epidemiological efficacy drop obtained for several vaccines against the B.1.1.7, B.1.351 P.1, and B.1.617 genotypes are of concern. There is a growing number of reports on mutations in receptor-binding domain (RBD) increasing the transmissibility of the virus and escaping the neutralizing effect of antibodies. The Sputnik V vaccine is currently approved for use in more than 66 countries but its activity against variants of concern (VOC) is not extensively studied yet. Virus-neutralizing activity (VNA) of sera obtained from people vaccinated with Sputnik V in relation to internationally relevant genetic lineages B.1.1.7, B.1.351, P.1, B.1.617.2, B.1.617.3 and Moscow endemic variants B.1.1.141 (T385I) and B.1.1.317 (S477N, A522S) with mutations in the RBD domain has been assessed. The data obtained indicate no significant differences in VNA against B.1.1.7, B.1.617.3 and local genetic lineages B.1.1.141 (T385I), B.1.1.317 (S477N, A522S) with RBD mutations. For the B.1.351, P.1, and B.1.617.2 statistically significant 3.1-, 2.8-, and 2.5-fold, respectively, VNA reduction was observed. Notably, this decrease is lower than that reported in publications for other vaccines. However, a direct comparative study is necessary for a conclusion. Thus, sera from “Sputnik V”-vaccinated retain neutralizing activity against VOC B.1.1.7, B.1.351, P.1, B.1.617.2, B.1.617.3 as well as local genetic lineages B.1.1.141 and B.1.1.317 circulating in Moscow.

In late 2021, the pandemic wave was dominated by the Delta SARS-CoV-2 variant in Hungary. Booster vaccines were offered for the vulnerable population starting from August 2021. The nationwide HUN-VE 3 study examined the effectiveness and durability of primary immunization and single booster vaccinations in the prevention of SARS-CoV-2 infection, Covid-19 related hospitalization and mortality during the Delta wave, compared to an unvaccinated control population without prior SARS-CoV-2 infection. The study population included 8,087,988 individuals who were 18-100 years old at the beginning of the pandemic. During the Delta wave, after adjusting for age, sex, calendar day, and chronic diseases, vaccine effectiveness (VE) of primary vaccination against registered SARS-CoV-2 infection was between 11% to 77% and 18% to 79% 14-120 days after primary immunization in the 16-64 and 65-100 years age cohort respectively, while it decreased to close to zero in the younger age group and around 40% or somewhat less in the elderly after 6 months for almost all vaccine types. In the population aged 65-100 years, we found high, 88.1%-92.5% adjusted effectiveness against Covid-19 infection after the Pfizer-BioNTech, and 92.2%-95.6% after the Moderna booster dose, while Sinopharm and Janssen booster doses provided 26.5%-75.3% and 72.9%-100.0% adjusted VE, respectively. Adjusted VE against Covid-19 related hospitalization was high within 14-120 days for Pfizer-BioNTech: 76.6%, Moderna: 83.8%, Sputnik-V: 78.3%, AstraZeneca: 73.8%, while modest for Sinopharm: 45.7% and Janssen: 26.4%. The waning of protection against Covid-19 related hospitalization was modest and booster vaccination with mRNA vaccines or the Janssen vaccine increased adjusted VE up to almost 100%, while the Sinopharm booster dose proved to be less effective. VE against Covid-19 related death after primary immunization was high or moderate: for Pfizer-BioNTech: 81.5%, Moderna: 93.2%, Sputnik-V: 100.0%, AstraZeneca: 84.8%, Sinopharm: 58.6%, Janssen: 53.3%). VE against this outcome also showed a moderate decline over time, while booster vaccine types restored effectiveness up to almost 100%, except for the Sinopharm booster. The HUN-VE 3 study demonstrated waning VE with all vaccine types for all examined outcomes during the Delta wave and confirmed the outstanding benefit of booster vaccination with the mRNA or Janssen vaccines, and this is the first study to provide clear and comparable effectiveness results for six different vaccine types after primary immunization against severe during the Delta pandemic wave.

To protect young individuals against SARS-CoV-2 infection, we conducted an open-label, prospective, non-randomised dose-escalation Phase 1/2 clinical trial to evaluate the immunogenicity and safety of the prime-boost “Sputnik V” vaccine administered at 1/10 and 1/5 doses to adolescents aged 12–17 years. The study began with the vaccination of the older cohort (15-to-17-year-old participants) with the lower (1/10) dose of vaccine and then expanded to the whole group (12-to-17-year-old participants). Next, 1/5 dose was used according to the same scheme. Both doses were well tolerated by all age groups. No serious or severe adverse events were detected. Most of the solicited adverse reactions were mild. No significant differences in total frequencies of adverse events were registered between low and high doses in age-pooled groups (69.6% versus 66.7%). In contrast, the 1/5 dose induced significantly higher humoral and T cell-mediated immune responses than the 1/10 dose. The 1/5 vaccine dose elicited higher antigen-binding (both S and RBD-specific) as well as virus-neutralising antibody titres at the maximum of response (day 42), also resulting in a statistically significant difference at a distanced timepoint (day 180) compared to the 1/10 vaccine dose. Higher dose resulted in increased cross-neutralization of Delta and Omicron variants.;

Background Vaccination is a key intervention to prevent COVID-19. Many vaccines are administered globally, yet there is not much evidence regarding their safety and adverse effects. Iran also faces this challenge, especially as data regarding the Sputnik V vaccine is sparse. Therefore, the aim of this study is to determine the adverse effects of the most commonly used vaccines in Iran. Methods Using a retrospective cohort study design, 6600 subjects aged 18 years or older who had received two doses of any of the three COVID-19 vaccines (Sinopharm, AstraZeneca, and Sputnik V) were selected using a random sampling method between March and August 2021. Subjects were asked about any adverse effects of the vaccines by trained interviewers via telephone interview. Vaccine-related adverse effects in individuals during the first 72 h and subsequently following both doses of the vaccines were determined. The demographic variables, type of administered vaccine, adverse effects, and history of the previous infection with COVID-19 were collected. Descriptive statistics (mean, standard deviation) and analytical statistics (Chi-squared and Wilcoxon tests) were performed at a 95% significance level using STATA software version 15 (STATA Corp, College Station, TX, USA). Results From 6600 participants, 4775 responded (response rate = 72.3%). Of the participants, 1460 (30.6%) received the AstraZeneca vaccine, 1564 (32.8%) received the Sinopharm vaccine and 1751 (36.7%) received the Sputnik V vaccine. 2653 participants (55.56%) reported adverse effects after the first dose and 1704 (35.7%) after the second dose. Sputnik V caused the most adverse effects with 1449 (82.7%) vaccine recipients reporting symptoms after the first or second dose, compared with 1030 (70.5%) for AstraZeneca and only 585 (37.4%) for the Sinopharm vaccine. The most common adverse effects after the first dose were fatigue (28.37%), chill/fever (26.86%), and skeletal pain (22.38%). These three adverse effects were the same for the second dose, although their prevalence was lower. Conclusions In this study, we demonstrate that the Sputnik V vaccine has the highest rate of adverse effects, followed by the AstraZeneca and Sinopharm vaccines. COVID-19 vaccines used in Iran are safe and there were no reports of serious adverse effects.

The rapid development and deployment of injectable coronavirus disease 2019 (COVID-19) vaccines - in combination with non-pharmaceutical interventions and development of treatment options - significantly contributed to a decrease in both infection and mortality rates during the pandemic and saved millions of lives. However, injectable vaccines do not robustly and consistently induce a mucosal immune response, which is considered a key factor to prevent infection with and transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Hence, a tremendous effort is being made globally to develop next generation COVID-19 vaccines, which are capable of inducing a robust mucosal immune response in addition to a strong systemic cellular and humoral immune response. Mucosal COVID-19 vaccines have been evaluated successfully in preclinical and clinical trials, in which protection against SARS-CoV-2 infection has been demonstrated. This protective efficacy was associated with the upregulation of secretory IgA antibodies and the maturation of tissue-resident memory cells in the respiratory tract, which, together with an induced systemic immune response, significantly reduced viral replication and transmission in animal models. However, only five active mucosal vaccines (plus one ‘passive’ vaccine) have received approval for human use and robust data on their efficacy in inducing mucosal immune responses in humans and in blocking infection and transmission are missing. This highlights the importance of expanded research in this field. In this review, we aim to summarize what is known about these currently licensed vaccines, with an emphasis on the key findings obtained in both preclinical and clinical studies.

There is a limited amount of data on the safety profile of the COVID-19 vector vaccine Gam-COVID-Vac (Sputnik V). Previous infodemiology studies showed that social media discourse could be analyzed to assess the most concerning adverse events (AE) caused by drugs. We aimed to investigate mild AEs of Sputnik V based on a participatory trial conducted on Telegram in the Russian language. We compared AEs extracted from Telegram with other limited databases on Sputnik V and other COVID-19 vaccines. We explored symptom co-occurrence patterns and determined how counts of administered doses, age, gender, and sequence of shots could confound the reporting of AEs. We collected a unique dataset consisting of 11,515 self-reported Sputnik V vaccine AEs posted on the Telegram group, and we utilized natural language processing methods to extract AEs. Specifically, we performed multilabel classifications using the deep neural language model Bidirectional Encoder Representations from Transformers (BERT) \"DeepPavlov,\" which was pretrained on a Russian language corpus and applied to the Telegram messages. The resulting area under the curve score was 0.991. We chose symptom classes that represented the following AEs: fever, pain, chills, fatigue, nausea/vomiting, headache, insomnia, lymph node enlargement, erythema, pruritus, swelling, and diarrhea. Telegram users complained mostly about pain (5461/11,515, 47.43%), fever (5363/11,515, 46.57%), fatigue (3862/11,515, 33.54%), and headache (2855/11,515, 24.79%). Women reported more AEs than men (1.2-fold, P<.001). In addition, there were more AEs from the first dose than from the second dose (1.1-fold, P<.001), and the number of AEs decreased with age (β=.05 per year, P<.001). The results also showed that Sputnik V AEs were more similar to other vector vaccines (132 units) than with messenger RNA vaccines (241 units) according to the average Euclidean distance between the vectors of AE frequencies. Elderly Telegram users reported significantly more (5.6-fold on average) systemic AEs than their peers, according to the results of the phase 3 clinical trials published in The Lancet. However, the AEs reported in Telegram posts were consistent (Pearson correlation r=0.94, P=.02) with those reported in the Argentinian postmarketing AE registry. After the Sputnik V vaccination, Russian Telegram users reported mostly pain, fever, and fatigue. The Sputnik V AE profile was comparable with other vector COVID-19 vaccines. Discussion on social media could provide meaningful information about the AE profile of novel vaccines.

The choice of vaccine platform fundamentally influences the magnitude and durability of antibody responses against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). We compared humoral immune responses between BNT162b2/mRNA-1273 (mRNA) and Sputnik V (adenoviral vector) vaccines across multiple timepoints. Anti-ancestral (WT) spike binding antibodies were measured by enzyme-linked immunosorbent assay (ELISA) and neutralizing antibodies by microneutralization assay using live SARS-CoV-2 WA.1 strain. Sera from 48 naïve and 24 convalescent study participants were collected prior and after the primary immunization (mRNA: 28; Sputnik V: 44). mRNA vaccines elicited higher binding antibody responses (p < 0.001 in naïve, p < 0.05 in convalescent participants) and neutralizing antibody responses (p < 0.001 in naïve participants) compared to Sputnik V. Antibody decay kinetics were similar between platforms (half-life ∼5 months), with mRNA vaccines maintaining sustained superiority through 6 months post-vaccination. mRNA vaccination provides markedly superior and sustained antibody responses compared to adenoviral vector vaccine, which is particularly relevant for long-term protection strategies.

Although unprecedented efforts aiming to stop the COVID-19 pandemic have been made over the past two years, SARSCoV-2 virus still continues to cause intolerable health and economical losses. Vaccines are considered the most effective way to prevent infectious diseases, which has been reaffirmed for COVID-19. However, in the context of the continuing virus spread because of insufficient vaccination coverage and emergence of new variants of concern, there is a high demand for vaccination strategy amendment. The ability to elicit protective immunity at the entry gates of infection provided by mucosal vaccination is key to block virus infection and transmission. Therefore, these mucosal vaccines are believed to be a \"silver bullet\" that could bring the pandemic to an end. Here, we demonstrate that the intranasally delivered Gam-COVID-Vac (Sputnik V) vaccine induced a robust (no less than 180 days) systemic and local immune response in mice. High immunogenic properties of the vaccine were verified in non-human primates (common marmosets) by marked IgG and neutralizing antibody (NtAb) production in blood serum, antigen-specific Tcell proliferation and cytokine release of peripheral blood mononuclear cells accompanied by formation of IgA antibodies in the nasal mucosa. We also demonstrate that Sputnik V vaccine can provide sterilizing immunity in K18-hACE2 transgenic mice exposed to experimental lethal SARS-CoV-2 infection protecting them against severe lung immunopathology and mortality. We believe that intranasal Sputnik V vaccine is a promising novel needle-free mucosal vaccine candidate for primary immunization as well as for revaccination and is worth further clinical investigation.

Mutations in surface proteins enable emerging variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to escape a substantial fraction of neutralizing antibodies and may thus weaken vaccine-driven immunity. To compare available vaccines and justify revaccination, rapid evaluation of antibody (Ab) responses to currently circulating SARS-CoV-2 variants of interest (VOI) and concern (VOC) is needed. Here, we developed a multiplex protein microarray-based system for rapid profiling of anti-SARS-CoV-2 Ab levels in human sera. The microarray system was validated using sera samples from SARS-CoV-2-free donors and those diagnosed with COVID-19 based on PCR and enzyme immunoassays. Microarray-based profiling of vaccinated donors revealed a substantial difference in anti-VOC Ab levels elicited by the replication-deficient adenovirus vector-base (Sputnik V) and whole-virion (CoviVac Russia COVID-19) vaccines. Whole-virion vaccine-induced Abs showed minor but statistically significant cross-reactivity with the human blood coagulation factor 1 (fibrinogen) and thrombin. However, their effects on blood clotting were negligible, according to thrombin time tests, providing evidence against the concept of pronounced cross-reactivity-related side effects of the vaccine. Importantly, all samples were collected in the pre-Omicron period but showed noticeable responses to the receptor-binding domain (RBD) of the Omicron spike protein. Thus, using the new express Ab-profiling system, we confirmed the inter-variant cross-reactivity of the anti-SARS-CoV-2 Abs and demonstrated the relative potency of the vaccines against new VOCs.