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1.
Advanced Therapeutics ; 6(5) (no pagination), 2023.
Article in English | EMBASE | ID: covidwho-20244710

ABSTRACT

Delivery of self-amplifying mRNA (SAM) has high potential for infectious disease vaccination due to its self-adjuvanting and dose-sparing properties. Yet a challenge is the susceptibility of SAM to degradation and the need for SAM to reach the cytosol fully intact to enable self-amplification. Lipid nanoparticles are successfully deployed at incredible speed for mRNA vaccination, but aspects such as cold storage, manufacturing, efficiency of delivery, and the therapeutic window can benefit from further improvement. To investigate alternatives to lipid nanoparticles, a class of >200 biodegradable end-capped lipophilic poly(beta-amino ester)s (PBAEs) that enable efficient delivery of SAM in vitro and in vivo as assessed by measuring expression of SAM encoding reporter proteins is developed. The ability of these polymers to deliver SAM intramuscularly in mice is evaluated, and a polymer-based formulation that yields up to 37-fold higher intramuscular (IM) expression of SAM compared to injected naked SAM is identified. Using the same nanoparticle formulation to deliver a SAM encoding rabies virus glycoprotein, the vaccine elicits superior immunogenicity compared to naked SAM delivery, leading to seroconversion in mice at low RNA injection doses. These biodegradable nanomaterials may be useful in the development of next-generation RNA vaccines for infectious diseases.Copyright © 2023 The Authors. Advanced Therapeutics published by Wiley-VCH GmbH.

2.
Vaccine ; 41(29): 4280-4286, 2023 06 29.
Article in English | MEDLINE | ID: covidwho-20230965

ABSTRACT

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants has significantly reduced the efficacy of some approved vaccines. A fourth dose of NVX-CoV2373 (5 µg SARS-CoV-2 recombinant spike [rS] protein + 50 µg Matrix-M™ adjuvant; Novavax, Gaithersburg, MD) was evaluated to determine induction of cross-reactive antibodies to variants of concern. A phase II randomized study (NCT04368988) recruited participants in Australia and the United States to assess a primary series of NVX-CoV2373 followed by two booster doses (third and fourth doses at 6-month intervals) in adults 18-84 years of age. The primary series was administered when the SARS-CoV-2 ancestral strain was prevalent and the third and fourth doses while the Alpha and Delta variants were prevalent in AUS and US. Local/systemic reactogenicity was assessed the day of vaccination and for 6 days thereafter. Unsolicited adverse events (AEs) were reported. Immunogenicity was measured before, and 14 days after, fourth dose administration, using anti-spike serum immunoglobulin G (IgG) and neutralization assays against ancestral SARS-CoV-2 strain and Omicron sublineages. Among 1283 enrolled participants, 258 were randomized to receive the two-dose primary series, of whom 104 received a third dose, and 45 received a fourth dose of NVX-CoV2373. The incidence of local/systemic reactogenicity events increased after the first three doses of NVX-CoV2373 and leveled off after dose 4. Unsolicited AEs were reported in 9 % of participants after dose 4 (none of which were severe or serious). Anti-rS IgG levels and neutralization antibody titers increased following booster doses to a level approximately four-fold higher than that observed after the primary series, with a progressively narrowed gap in response between the ancestral strain and Omicron BA.5. A fourth dose of NVX-CoV2373 enhanced immunogenicity for ancestral and variant SARS-CoV-2 strains without increasing reactogenicity, indicating that updates to the vaccine composition may not be currently warranted.


Subject(s)
COVID-19 , Adult , Humans , COVID-19/prevention & control , SARS-CoV-2 , Immunoglobulin G , Immunogenicity, Vaccine , Antibodies, Viral , Antibodies, Neutralizing
3.
Rheumatology (United Kingdom) ; 62(Supplement 2):ii51, 2023.
Article in English | EMBASE | ID: covidwho-2326056

ABSTRACT

Background/Aims Patients with immune-mediated rheumatic diseases (IMRD) are commonly treated with immunosuppressors and are prone to infections. Recently introduced mRNA SARS-Cov2 vaccines have demonstrated extraordinary efficacy across all ages. Immunosuppressed patients were excluded from phase III trials with SARS-We aim to fully characterize B and T cell immune responses elicited by mRNA SARS-Cov2 vaccines in patients with rheumatic diseases under immunotherapies, and to identify which drugs reduce vaccine's immunogenicity. Methods Humoral, CD4 and CD8 immune responses were investigated in 147 SARS-Cov2-naive patients with selected rheumatic diseases under immunosuppression after a two-dose regimen of SARS-Cov2 mRNA vaccine. Responses were compared with age, gender, and diseasematched IMRD patients not receiving immunosuppressors and with healthy controls Results IMRD patients showed decreased seroconversion rates (63% vs 100%, p=0.04) and cellular immune responses (59% vs 100%, p=0.007). Patients on methotrexate achieved seroconversion in 62% of cases and cellular responses in 80% of cases. Abatacept deeply affected humoral and cellular responses. Rituximab (31% responders) and belimumab (50% responders) showed severely impaired humoral responses but cellular responses were often preserved. Antibody titers were reduced with mycophenolate and azathioprine but preserved with leflunomide. Conclusion IMRD patients exhibit impaired SARS-CoV-2 vaccine-immunogenicity, variably reduced with immunosuppressors. Among commonly used therapies, abatacept and B-cell depleting therapies show the most deleterious effects, while anticytokines preserved immunogenicity. The effects of cumulative methotrexate and glucocorticoid doses on immunogenicity should be considered. Humoral and cellular responses are weakly correlated, but CD4 and CD8 tightly correlate. Seroconversion alone might not reflect the vaccine's immunogenicity.

4.
Respirology ; 28(Supplement 2):235, 2023.
Article in English | EMBASE | ID: covidwho-2318848

ABSTRACT

Introduction/Aim: The development of safe and effective vaccines is crucial to conquering the COVID-19 pandemic. Recombinant proteins represent the best understood and reliable approach to pandemic vaccine delivery with well-established safety;however, they face challenges in design, structural characterisation, manufacture, potency testing and ensuring adequate immunogenicity. Method(s): Our team used in silico structural modelling to design a vaccine based on a stabilised spike protein extracellular domain (ECD). The insect cell expressed recombinant spike ECD was formulated with Vaxine's proprietary Advax-CpG55.2 adjuvant. Result(s): The vaccine known as Covax-19 or SpikoGen induced high titers of antibody and memory T-cells which translated to protection against SARS-CoV-2 infection in hamsters, ferrets, and aged monkeys. Despite numerous challenges along the journey, clinical trials in Iran during a major wave of delta variant infection confirmed SpikoGen vaccine was 78% effective in reducing risk of severe disease and with no evidence of vaccine-associated thrombosis, myocarditis, or sudden death, receiving marketing approval under emergency use authorisation in Iran on 6 October 2021. This made it the first recombinant spike-protein vaccine in the world to be approved, and the first Australian-developed human vaccine to receive marketing approval in four decades. Since approval millions of doses have been administered and additional trials in Australia and Iran have confirmed its effectiveness as a booster to prevent waning immunity, as well as its safety and effectiveness in children from the age of 5 years. The ongoing Australian and overseas clinical trial program is focussed on gaining better understanding the effect of dosing intervals on vaccine immunogenicity, gathering additional data on use as a booster, and development of new variant formulations. Conclusion(s): Covax-19/Spikogen is safe and effective adjuvanted recombinant protein vaccine.

5.
Topics in Antiviral Medicine ; 31(2):147-148, 2023.
Article in English | EMBASE | ID: covidwho-2318500

ABSTRACT

Background: Immune responses to SARS-CoV-2 vaccines in people living with HIV (PLWH) have been the focus of several recent studies. As the gut microbiome can influence vaccine immunogenicity, in this study we are the first to investigate whether the baseline gut microbiota can predict immune responses to the BNT162b2 SARS-CoV-2 vaccine in people living with HIV (PLWH) and healthy controls (HC). Method(s): Fecal samples were collected from PLWH (n=68) and HC (n=75) at baseline, prior to the first vaccine dose, to extract DNA for 16S rRNA sequencing. The individuals were part of the COVAXID Clinical trial, where humoral and cellular responses to SARS-CoV-2 vaccine were evaluated on day 35 after the first dose. Comprehensive bioinformatic tools were used for bacterial identification to further reveal the associations between gut microbiota and SARS-CoV-2 antibody, spike CD4+ T cell responses, and clinical parameters such as age, gender, CD4/CD8 ratio, and length of antiretroviral (ART) treatment. Result(s): At day 35 post vaccination, HC showed significantly higher spike IgG titers than PLWH (p=0.0001). Interestingly, both phylogenetic and alpha-diversity were negatively correlated with antibody titers, in the whole cohort and within groups. Similarly, individuals with low alpha-diversity had higher levels of spike specific CD4+T-cell responses. Agathobacter, Lactobacillus, Bacteroides, and Lachnospira were positively correlated with both antibody levels and spike-specific CD4+ T-cell responses while Methanobrevibacter, Marvinbryantia, Cloacibacillus, and Succinivibrio have a negative one. Within the PLWH group, the gut microbiota taxa associated with CD4+ counts, such as Lachnospira (p=0.002), Oscillibacter (p=0.019) and Flavonifractor (p=0.017), were found to be positively correlated with spike IgG levels. Additionally, the length of ART treatment and CD4/CD8 ratio displayed a positive association with bacterial diversity. Notably, different microbiome profiles and immune status in PLWH, affect their immune responses to vaccination. Conclusion(s): Our results show potential associations between gut microbiota diversity and spike IgG responses after COVID-19 vaccination. These findings were consistent in the whole cohort, albeit group differences between the microbiome compositions in PLWH and HC were observed. Based on our findings, we propose that microbiome modulation could optimize immunogenicity to SARS-Cov-2 vaccines.

6.
Drugs of the Future ; 48(1):63-67, 2023.
Article in English | EMBASE | ID: covidwho-2317670

ABSTRACT

IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). For the first time since the COVID-19 public health emergency began, IDWeek 2022 returned to in-person attendance. It was held in Washington, D.C., and the meeting comprised 5 days of live sessions and on-demand content that included posters and oral presentations.Copyright © 2023 Clarivate.

7.
Topics in Antiviral Medicine ; 31(2):367, 2023.
Article in English | EMBASE | ID: covidwho-2316404

ABSTRACT

Background: As part of an international multi-country study on COVID-19 vaccine immunogenicity (InVITE, NCT05096091), we sought to characterize baseline anti-Nucleocapsid (N) and anti-Spike (S) seropositivity by country and by self-report of prior positive SARS-CoV-2 test result. Method(s): 3063 vaccine-naive individuals from the InVITE study cohort, who received a COVID-19 vaccine as part of their country's national immunization programs at participating sites in Democratic Republic of Congo (DRC), Guinea, Liberia and Mali, were enrolled between August 2021 and February 2022. Demographic and baseline characteristics were collected at study enrollment. Blood was collected at baseline prior to initiation of the vaccine regimen. SARS-CoV-2 anti-S antibody and anti-N antibody levels were measured using Quanterix anti-S IgG semi-quantitative antibody and BioRad Platelia SARSCoV- 2 anti-N Total Ab assays, respectively. Demographic characteristics were assessed for association with positive anti-S and anti-N serology. Result(s): Baseline demographics and serology results by country and overall are shown in the table. Conclusion(s): Despite low numbers of prior self-reported positive SARS-CoV-2 test, the serology results in this cohort indicate prior infection in a significant proportion of the InVITE study participants prior to receipt of a first dose of COVID-19 vaccination. These results suggest widespread previous SARS-CoV-2 infections that were unrecognized possibly due to mild-no symptoms, poor access to/availability of testing and/or limited monitoring through surveillance. Baseline Demographics and Serology Results.

8.
Journal of Young Pharmacists ; 15(2):245-256, 2023.
Article in English | EMBASE | ID: covidwho-2315085

ABSTRACT

Aim and Background: The coronavirus disease 2019 (Covid-19) virus pandemic is still ravaging the world with its ongoing resurgence and the continuous mutation, suggesting the need for continuous research on safe and effective novel vaccines. Presently several types of vaccines have been developed and emerged in the global market to control COVID-19 virus. Consequently, the knowledge and information on COVID-19 have been expanding at a high level. Researchers need to gain relevant knowledge regarding the different vaccines;however scattered information makes this process time-consuming and laborious. The present study aimed to evaluate the characteristics and trends in global COVID-19 vaccine high-cited literature using bibliometric and visualizations methods and offer some directions and suggestions for future research. Methodology: Studies published between December 2019 and 22 Nov 2022 on COVID-19 vaccines were retrieved from the Scopus database. From the 16026 studies retrieved, 406 were identified as high-cited papers (HCPs) having received 100 or more citations. From the 406 HCPs, information about publications outputs, countries, institutions, journals, keywords, and citation counts was identified. Data analysis and visualization were conducted using Microsoft Excel, VOSviewer and Bibliometrix R software. Result(s): The 406 global HCPs on COVID-19 vaccines research were identified in Scopus database since Dec 2019 till 30 Nov 2022 using a search strategy, which received 123614 citations, averaging 304.17 citations per publication (CPP). An external funding was received by 53.20% (216 publications), which were cited 76107 times (with an average of 352.35 CPP). The 7086 authors from 694 organizations affiliated to 76 countries and publishing in 121 journals were involved in global COVID-19 vaccine research. The most productive countries were USA (n=213), U.K (n=91), China (n=36) and Germany (n=35). The most impactful countries in terms of citations per paper (CPP) and relative citation index (RCI) were South Africa (794.68 and 2.61), Germany (507.11 and 1.67), U.K. (396.59 and 1.30) and Spain (367.5 and 1.121). The most productive organizations were University of Oxford, U.K., Imperial College London, U.K. (n=25 each), Center for Disease Control and Prevention (CDC), USA and Tel Aviv University (n=19 each) and the most impactful organizations were University of Cambridge, U.K (783.4 and 2.57), Emory University, USA (780.1 and 2.56), John Hopkins Bloomberg School of Public Health, USA (702.67 and 2.31) and National Institute of Allergy and Infectious Diseases. USA (676.41 and 2.22). The most productive authors were A.J. Pollard (n=16) and T. Lambe (n=14) (of University of Oxford), O. Tureci and P.R. Dormitzer (n=12 each) (of BioNTechSE, Germany) and the most impactful were D. Cooper (1239.22 and 4.07), K.J. Janseu (1228.11 and 4.03) (BioNTechSE, Germany, K.A. Swanson (987.0 and 3.24) (University of Oxford, U.K.) and P.R. Dormitzer (983 and 3.23) (BioNTechSE, Germany). The most productive journals were New England Journal of Medicine (n=53), The Lancet (n=28), Nature (n=22) and JAMA (N=17). The most impactful journals (as per citations per paper) were New England Journal of Medicine (613.15), Lancet (496.39), Human Vaccines and Immunotherapeutics (369.67) and Nature (360.64). Among population age groups, the major focus was on adults (51.48%) and Middle Aged (39.16%). Among publication types, the major focus was Clinical Studies (26.85%), Epidemiology (22.66%) and Genetics (21.92%). The most significant keywords by frequency of appearances were "Covid-19" (n=388), "Covid-19 Vaccines" (n=357), "Vaccination" (n=221), "Prevention and Control" (n=181) and "Vaccine Immunogenicity" (n=133), Conclusion(s): The HCPs in COVID-19 vaccine research was done mainly by the authors and institutions of high-income Countries (HIC) and was published in high-impact medical journals. Our research has identified the leading countries, institutions, journals, hotspots and development trend in the field that could provide the foundati n for further investigations. The bibliometric analysis will help the clinicians to rapidly identify the potential collaborative partners, identify significant studies, and research topics within their domains of COVID-19 vaccines.Copyright Author (s) 2023.

9.
Journal of Liver Transplantation ; 4 (no pagination), 2021.
Article in English | EMBASE | ID: covidwho-2298219
10.
Journal of Liver Transplantation ; 8 (no pagination), 2022.
Article in English | EMBASE | ID: covidwho-2297028
11.
Complex Issues of Cardiovascular Diseases ; 11(2):196-203, 2022.
Article in Russian | EMBASE | ID: covidwho-2294438

ABSTRACT

The COVID-19 pandemic is going on, which makes it crucial to prevent the spread of coronavirus disease. Vaccination is the only way of specific prevention of COVID-19. The SARS-CoV-2 virus is continuously evolving and new variants appear. Moreover, the effectiveness of protective immunity after vaccination tends to decrease over several months. Booster vaccination may be the solution to these problems. The booster is an extra vaccination that helps to reactivate the immunity against COVID-19. Booster doses can be homologous (the same as the primary vaccine) and heterologous (different from the primary vaccine). It is of current interest to study heterologous vaccination as the injection of different vaccines may result in a more intense immune response. Furthermore, the same vaccine may not be available at the time of booster vaccination. This review is aimed at summarizing the key research findings in the field of booster vaccination against COVID-19.Copyright © 2022 Booster vaccination against. All rights reserved.

12.
Vaccines (Basel) ; 11(4)2023 Mar 23.
Article in English | MEDLINE | ID: covidwho-2300738

ABSTRACT

BACKGROUND: Vaccines that prevent SARS-CoV-2 infection are considered the most promising approach to modulating the pandemic. There is scarce evidence on the efficacy and safety of different vaccine prime-boost combinations in MHD patients since most clinical trials have used homologous mRNA vaccine regimens. METHODS: This prospective observational study assessed the immunogenicity and safety of homologous CoronaVac® (SV-SV), ChAdOx1 nCoV-19 (AZD1222) (AZ-AZ), and the heterologous prime-boost of SV-AZ, among MHD patients. RESULTS: A total of 130 MHD participants were recruited. On day 28, after the second dose, seroconversion results of the surrogate virus neutralization test were not different between vaccine regimens. The magnitude of the receptor-binding domain-specific IgG was highest among the SV-AZ. Different vaccine regimens had a distinct impact on seroconversion, for which the heterologous vaccine regimen demonstrated a higher probability of seroconversion (OR 10.12; p = 0.020, and OR 1.81; p = 0.437 for SV-AZ vs. SV-SV, and SV-AZ vs. AZ-AZ, respectively). There were no serious adverse events reported in any of the vaccine groups. CONCLUSIONS: Immunization with SV-SV, AZ-AZ, and SV-AZ could generate humoral immunity without any serious adverse events among MHD patients. Using the heterologous vaccine prime-boost seemed to be more efficacious in terms of inducing immunogenicity.

13.
Kidney International Reports ; 8(3 Supplement):S455-S456, 2023.
Article in English | EMBASE | ID: covidwho-2275731

ABSTRACT

Introduction: We report results on immunogenicity of the recombinant adenovirus (rAd) 26 and rAd5 vector-based COVID-19 vaccine Gam-COVID-Vac (Sputnik V, developed by Gamaleya National Research Centre, Russia) in patients, receiving maintenance hemodialysis (HD). We aimed to compare the dynamics of humoral and cellular immunity after 2 doses of Gam-COVID-Vac in patients receiving HD and individuals with normal kidney function. Method(s): We recruited 23 patients treated with maintenance HD and 28 volunteers with normal kidney function (control group). All participates were adult, had been vaccinated twice with Gam-COVID-Vac vaccine and had no prior history of confirmed COVID-19. In all participants, the levels of anti-SARS-CoV-2-specific IgG were quantified at 1 month and 6 months from the second vaccine shot using ELISA. Specific T-cell responses (CD4+ and CD8+ cytotoxic T-lymphocytes) were evaluated using the TIGRA-test (Generium, Russia) at the same timepoints. [Formula presented] Results: Participant's characteristics and tolerability data are summarized in Table 1. Patients receiving HD were older and had more comorbidities compared with the control group. The seropositivity rate declined in both groups over time and was 100% vs 68% in non-renal controls and 91% vs 50% in HD group at months 1 and 6, respectively. In both groups, IgG levels decreased from month 1 to 6, however, antibodies did not vanish more rapidly in the HD group (analysis of variance p = 0.709 for the "time x group" interaction, age-adjusted model) - Figure 1. [Formula presented] IgG levels correlated inversely with age of HD patients (rho= -0.42 [95% CI: -0.64;-0.13], p=0.0047), whereas no correlation was observed in control group. Initially, the T-test result was positive in 79% non-renal and 73% HD subjects. At the end of the study, 48% non-renal and 64% HD participants showed T-cell positivity. T-spot responses to SARS-CoV-2 structural peptides S did not differ in the control group and in patients receiving HD at month 1 (p = 0.75) and 6 (p = 0.6) after vaccination. However, T-spot counts dropped over time in non-renal controls, but not in HD subjects (p=0.008 and p=0.18, respectively) - Figure 2. Over the course of the study, there were 2 confirmed cases of COVID-19 reinfection in control group, and 1 case in HD group. Conclusion(s): Patients receiving hemodialysis maintain significant long-term humoral response after vaccination with Gam-COVID-Vac vaccine, which is comparable to that in subjects with normal kidney function. Cellular response turned up to be more sustained over time in HD group. [Formula presented] No conflict of interestCopyright © 2023

14.
Journal of Laboratory and Precision Medicine ; 7 (no pagination), 2022.
Article in English | EMBASE | ID: covidwho-2271338

ABSTRACT

Predicting the humoral, cellular and clinical response to coronavirus disease 2019 (COVID-19) vaccination remains a central aspect for efficiently tackling the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Several current studies have focused on predicting the clinical response to COVID-19 vaccination by testing both immunological and cellular biomarkers. Nonetheless, this strategy is plagued by a number of drawbacks, so that a "biological marker" which may help predicting vaccine efficacy, efficiently surrogating laboratory-based tests, would be a valuable resource for optimizing vaccine delivery. A number of recent studies, summarized in this clinical practice review, have repeatedly emphasized the existence of a significant relationship between increased body temperature and humoral response after mRNA-based COVID-19 vaccination. Therefore, we put forward the idea that fever should be no longer considered only an adverse (almost undesirable) post-vaccination side effect, wherein its onset may actually reflect enhanced immunological response to vaccine, and its measurement could hence be used for screening at least mRNA-based vaccine immunogenicity in terms of humoral response up to 3 months after mRNA-based COVID-19 vaccination by using specifically validated algorithms incorporating the integrate assessment of body temperature and anti-SARS-CoV-2 antibodies.Copyright © Journal of Laboratory and Precision Medicine. All rights reserved.

15.
International Journal on Advanced Science, Engineering and Information Technology ; 13(1):130-140, 2023.
Article in English | Scopus | ID: covidwho-2270412

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) is still surging across the globe and has affected serious problems for both health and the global economy;therefore, the development of a vaccine with good efficacy becomes a must. To tackle the pandemic, numerous sectors of academia, industry, and the government collaborate to develop and investigate potential vaccine platforms. The recombinant subunit vaccine is one of the safest types of vaccine. However, its development has lagged behind other platforms, owing to the need for greater antigen manufacturability and immunogenicity. In this review, we outline several protein engineering strategies carried out in developing the recombinant COVID-19 vaccine, including the fusion of antigens with Fc fragment of human IgG, carrier proteins, trimerization domains, and stabilizing mutations. A systematic literature review was performed to summarize key takeaways from studies on developing recombinant subunit vaccines of SARS-CoV, MERS-CoV, and SARS-CoV-2, highlighting vaccine design and expression system, antigen structure, and in vivo and in vitro results of each protein engineering strategy. Several protein engineering strategies, particularly S protein and RBD, can improve the antigen's stability, manufacturability, and immunogenicity. Finally, novel protein engineering strategies are expected to be further developed to increase the vaccines' overall manufacturing, and the current recombinant vaccine candidates will be further processed into clinical stages to confirm their efficacy against pathogenic human coronaviruses. © 2023, International Journal on Advanced Science, Engineering and Information Technology. All Rights Reserved.

16.
Journal of Crohn's and Colitis ; 17(Supplement 1):i32-i34, 2023.
Article in English | EMBASE | ID: covidwho-2269457

ABSTRACT

Background: Anti-tumour necrosis factor drugs such as infliximab are associated with attenuated antibody responses after COVID-19 vaccination It is unknown how infliximab impacts vaccine-induced serological responses against highly transmissible Omicron variants, which possess the ability to evade host immunity and are now the dominating variants causing current waves of infection Methods: In this prospective, multicentre, observational cohort study we investigated neutralising antibody responses against SARS-CoV-2 wild-type and Omicron BA.1 and BA.4/5 variants after three doses of COVID-19 vaccination in 1288 patients with IBD without prior COVID-19 infection, who were established on either infliximab (n=871) or vedolizumab (n=417). Cox proportional hazards models were constructed to investigate the risk of breakthrough infection in relation to neutralising antibody titres Results: Following three doses of COVID-19 vaccine, neutralising titre NT50 (half-inhibitory neutralising titre) was significantly diminished in patients treated with infliximab as compared to patients treated with vedolizumab, against wild-type, BA.1 and BA.4/5 variants (Fig 1). Patients with Crohn's disease showed lower antibody NT50 compared to patients with ulcerative colitis against wild-type strain and BA.4/5 (Fig 2). Older age and thiopurine were independently associated with lower NT50 against wild-type strain and BA.4/5 (Fig 2). Non-white ethnicity was associated with higher NT50 compared to white ethnicity against wild-type strain, BA.1 and BA.4/5 (Fig 2). Breakthrough infection was significantly more frequent in patients treated with infliximab compared to patients treated with vedolizumab (Fig 3). Cox proportional hazards models of time to breakthrough infection after the third dose showed infliximab treatment to be associated with a higher hazard risk (HR) of 1.71 (95% CI [1.08 to 2.71], p=0.022) compared to vedolizumab (Fig 4). Higher neutralising antibody titres against BA.4/5 were associated with a lower hazard risk and a longer time to breakthrough infection (HR 0.87 [0.79 to 0.95] p=0.0028) (Fig 4) Conclusion(s): Following a third COVID-19 vaccine dose, patients established on infliximab treatment have significantly lower neutralising titres against SARS-CoV-2, which were especially low against Omicron variants. Increased breakthrough infection in infliximab recipients was associated with lower neutralising antibody titres against BA.4/5. These data underline the importance of continued COVID-19 vaccination programs, including second-generation bivalent vaccines, especially in patient subgroups where vaccine immunogenicity and efficacy may be reduced.

17.
BIOpreparations ; Prevention, Diagnosis, Treatment. 22(4):435-445, 2022.
Article in Russian | EMBASE | ID: covidwho-2266616

ABSTRACT

In November 2020, the Armed Forces of the Russian Federation began mass immunisation of the personnel with Gam-COVID-Vac (Sputnik V), the first Russia vaccine against the new coronavirus infection (COVID-19). Thus, it became necessary to assess post-vaccination antibody levels and the duration and intensity of humoral immunity to COVID-19. The aim of the study was to investigate the immunogenicity and efficacy of Gam-COVID-Vac in military medical staff after vaccination. Material(s) and Method(s): the authors determined the presence of specific antibodies in the serum of individuals immunised with Gam-COVID-Vac (477 volunteers) and COVID-19 convalescents (73 patients), using virus neutralisation (VN), enzyme-linked immunosorbent assay (ELISA) with reagent kits by several manufacturers, and immunoblotting. The results of the study were evaluated using analysis of variance. Result(s): VN detected virus neutralising antibodies in 90.7% of vaccinated subjects;ELISA, in 95.4%. Both VN and ELISA showed lower antibody levels in the vaccinated over 50 years of age. ELISA demonstrated a significantly higher concentration of anti-SARS-CoV-2 spike IgG in the Gam-COVID-Vac group than in the COVID-19 convalescent group. The correlation between antibody detection results by VN and ELISA was the strongest when the authors used their experimental reagent kit for quantitative detection of virus neutralising antibodies by competitive ELISA with the recombinant human ACE2 receptor. Having analysed the time course of neutralising antibody titres, the authors noted a significant, more than two-fold decrease in geometric means of the titres three months after administration of the second vaccine component. Conclusion(s): the subjects vaccinated with Gam-COVID-Vac gain effective humoral immunity to COVID-19. The decrease in titres indicates the need for revaccination in 6 months.Copyright © 2023 Safety and Risk of Pharmacotherapy. All rights reserved.

18.
Flora ; 27(4):519-526, 2022.
Article in Turkish | EMBASE | ID: covidwho-2285236

ABSTRACT

Despite the development of new antigens and adjuvants in conventional vaccine studies, different approaches are required in vaccine formulations due to the poor immunogenicity, in vivo intrinsic instability, toxicity, and the need for multiple administrations of conventional vaccines. To overcome these problems, nanotechnology approaches have recently been incorporated into vaccine formulations. As the development of vaccines is directed towards "minimal" compositions with low immunogenicity, there is an increasing need for new formulations that enhance the efficacy of antigens and adjuvants. There is an urgent need to regulate existing advanced treatment options for the global health threat posed by COVID-19, as well as to accelerate the development of new vaccines and drugs. Nano-sized carrier systems developed for the diagnosis and treatment of many diseases, especially cancer, continue to maintain their importance in the COVID-19 pandemic. The use of nanoparticles in medicine started about 30 years ago, but gained momentum with the pandemic and reached many people in a short time with vaccine formulation. The rapid development, approval and delivery of SARS-CoV-2 vaccines is one of the most important achievements in the history of medicine, and nanomedicine is part of that history. Within the scope of the review, up-to-date information was given about the use of nanotechnology and nanoparticles in COVID-19 vaccine development studies.Copyright © Telif Hakki 2022 Flora.

19.
Antibiotiki i Khimioterapiya ; 67(5-6):70-80, 2022.
Article in Russian | EMBASE | ID: covidwho-2251756

ABSTRACT

The problem of coronavirus disease 2019 (COVID-19) still remains relevant even now, after two years. As one of the methods of combating the current COVID-19 pandemic, most experts suggest the widespread use of vaccination. The use of anticovid vaccines in patients with rheumatic diseases raises a number of questions related to efficacy, immunogenicity (especially in patients receiving immunosuppressive therapy), as well as safety of immunization. With that in mind, it is very important to analyze the data on the above-mentioned aspects in real time. This review presents the results of studies on COVID-19 vaccination immunogenicity in rheumatology conducted over the past two years. The ability of a number of antirheumatic drugs to have a negative effect (to varying degrees) on the post-vaccination response has been demonstrated. Interpretation and comparison of the results of vaccine immunogenicity studies are complicated by a number of factors usually associated with the design of works. Within the framework of the problem under consideration, there are still a sufficient number of questions, the answers to which should be found in further research.Copyright © Team of Authors, 2022.

20.
Antibiotiki i Khimioterapiya ; 67(5-6):70-80, 2022.
Article in Russian | EMBASE | ID: covidwho-2251755

ABSTRACT

The problem of coronavirus disease 2019 (COVID-19) still remains relevant even now, after two years. As one of the methods of combating the current COVID-19 pandemic, most experts suggest the widespread use of vaccination. The use of anticovid vaccines in patients with rheumatic diseases raises a number of questions related to efficacy, immunogenicity (especially in patients receiving immunosuppressive therapy), as well as safety of immunization. With that in mind, it is very important to analyze the data on the above-mentioned aspects in real time. This review presents the results of studies on COVID-19 vaccination immunogenicity in rheumatology conducted over the past two years. The ability of a number of antirheumatic drugs to have a negative effect (to varying degrees) on the post-vaccination response has been demonstrated. Interpretation and comparison of the results of vaccine immunogenicity studies are complicated by a number of factors usually associated with the design of works. Within the framework of the problem under consideration, there are still a sufficient number of questions, the answers to which should be found in further research.Copyright © Team of Authors, 2022.

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