Analysis of spontaneous reports of suspected adverse reactions after vaccination against COVID-19 in Slovakia

Lassánová, M; Laššán, Štefan; Líšková, Silvia; Tesař, Tomáš; Cicova, Monika

doi:10.3389/fphar.2023.1097890

Cited by 5 publications

(4 citation statements)

References 16 publications

(23 reference statements)

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“…We developed an electronic case report form (CRF) using our institution’s web-based software to collect research information, including patients’ and donors’ characteristics, concurrent medications, lymphocyte subpopulation count, and SARS-CoV-2 anti-S1 titers. To evaluate the safety profiles of a new RBD–TT-conjugated SARS-CoV-2 vaccine, we employed active surveillance systems to report any vaccination-related adverse events through daily telenursing calls, which have a higher accuracy than passive monitoring in specific population subgroups ( 28 , 29 ).…”

Section: Methodsmentioning

confidence: 99%

Three doses of a recombinant conjugated SARS-CoV-2 vaccine early after allogeneic hematopoietic stem cell transplantation: predicting indicators of a high serologic response—a prospective, single-arm study

et al. 2023

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BackgroundAllogeneic hematopoietic stem cell transplant (allo-HSCT) recipients must be vaccinated against SARS-CoV-2 as quickly as possible after transplantation. The difficulty in obtaining recommended SARS-CoV-2 vaccines for allo-HSCT recipients motivated us to utilize an accessible and affordable SARS-CoV-2 vaccine with a recombinant receptor-binding domain (RBD)–tetanus toxoid (TT)-conjugated platform shortly after allo-HSCT in the developing country of Iran.MethodsThis prospective, single-arm study aimed to investigate immunogenicity and its predictors following a three-dose SARS-CoV-2 RBD–TT-conjugated vaccine regimen administered at 4-week (± 1-week) intervals in patients within 3–12 months post allo-HSCT. An immune status ratio (ISR) was measured at baseline and 4 weeks (± 1 week) after each vaccine dose using a semiquantitative immunoassay. Using the median ISR as a cut-off point for immune response intensity, we performed a logistic regression analysis to determine the predictive impact of several baseline factors on the intensity of the serologic response following the third vaccination dose.ResultsThirty-six allo-HSCT recipients, with a mean age of 42.42 years and a median time of 133 days between hematopoietic stem cell transplant (allo-HSCT) and the start of vaccination, were analyzed. Our findings, using the generalized estimating equation (GEE) model, indicated that, compared with the baseline ISR of 1.55 [95% confidence interval (CI) 0.94 to 2.17], the ISR increased significantly during the three-dose SARS-CoV-2 vaccination regimen. The ISR reached 2.32 (95% CI 1.84 to 2.79; p = 0.010) after the second dose and 3.87 (95% CI 3.25 to 4.48; p = 0.001) after the third dose of vaccine, reflecting 69.44% and 91.66% seropositivity, respectively. In a multivariate logistic regression analysis, the female sex of the donor [odds ratio (OR) 8.67; p = 0.028] and a higher level donor ISR at allo-HSCT (OR 3.56; p = 0.050) were the two positive predictors of strong immune response following the third vaccine dose. No serious adverse events (i.e., grades 3 and 4) were observed following the vaccination regimen.ConclusionsWe concluded that early vaccination of allo-HSCT recipients with a three-dose RBD–TT-conjugated SARS-CoV-2 vaccine is safe and could improve the early post-allo-HSCT immune response. We further believe that the pre-allo-HSCT SARS-CoV-2 immunization of donors may enhance post-allo-HSCT seroconversion in allo-HSCT recipients who receive the entire course of the SARS-CoV-2 vaccine during the first year after allo-HSCT.

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Section: Methodsmentioning

confidence: 99%

Three doses of a recombinant conjugated SARS-CoV-2 vaccine early after allogeneic hematopoietic stem cell transplantation: predicting indicators of a high serologic response—a prospective, single-arm study

et al. 2023

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“…Therefore, it is currently impossible to accurately evaluate the efficacy of anti‐fibrotic drugs in the treatment of PCPF. Unfortunately, the patients with PCPF succumb to respiratory failure and death [1, 15].…”

Section: Discussionmentioning

confidence: 99%

“…The coronavirus disease 2019 (COVID‐19) has caused public health crises worldwide due to lack of effective treatment and high mortality rate [1]. Pulmonary fibrosis (PF) is one of the serious complications of COVID‐19 that is caused by severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) [2, 3].…”

Section: Introductionmentioning

confidence: 99%

Targeting mevalonate pathway by zoledronate ameliorated pulmonary fibrosis in a rat model: Promising therapy against post‐COVID‐19 pulmonary fibrosis

Mohamed,

Abdel hay,

Fawzy

et al. 2024

Fundamemntal Clinical Pharma

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BackgroundRho kinase (ROCK) pathway plays a critical role in post‐COVID‐19 pulmonary fibrosis (PCPF) and its intervention with angiotensin‐converting enzyme 2 (ACE2) and vascular endothelial growth factor (VEGF) will be a potential therapeutic target.ObjectivesThe present study was conducted to investigate the efficacy of zoledronate (ZA) on carbon tetrachloride (CCl4) induced pulmonary fibrosis (PF) in rats through targeting ACE2, ROCK, and VEGF signaling pathways.MethodsFifty male Wistar rats were divided into five groups: control, vehicle‐treated, PF, PF‐ZA 50, and PF‐ZA 100 groups. ZA was given in two different doses 100 and 50 μg/kg/week intraperitoneally. After anesthesia, mean arterial blood pressure (MBP) was measured. After scarification, lung coefficient was calculated. Lung levels of ACE 2, interleukin‐1β (IL‐1β), transforming growth factor‐β (TGF‐β), VEGF, glutathione (GSH), and superoxide dismutase (SOD) were measured. Expression of ROCK, phosphorylated myosin phosphatase target subunit 1 (P‐MYPT1), and matrix metalloproteinase (MMP‐1), along with histopathological changes and immune‐histochemical staining for lung α‐smooth muscle actin (α‐SMA), tumor necrosis factor‐alpha (TNFα), and caspase‐3, were evaluated.ResultsZA significantly prevented the decrease in MBP. ZA significantly increased ACE2, GSH, and SOD and significantly decreased IL‐1β, TGF‐β, and VEGF in lung in comparison to PF group. ZA prevented the histopathological changes induced by CCl4. ZA inhibited lung expression of ROCK, P‐MYPT1, MMP‐1, α‐SMA, TNFα, and caspase‐3 with significant differences favoring the high dose intervention.ConclusionZA in a dose‐dependent manner prevented the pathological effect of CCl4 in the lung by targeting mevalonate pathway. It could be promising therapy against PCPF.

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“…22 In fact, drugs for IPF, including pirfenidone and nintedanib, have been co-opted during emergency treatment of PCPF. 23 Thus, shared genetic associations between critically ill COVID-19 and IPF might reflect common pathophysiology that could be utilized for therapeutic benefit in both diseases.…”

Section: Introductionmentioning

confidence: 99%

Context-specific eQTLs reveal causal genes underlying shared genetic architecture of critically ill COVID-19 and idiopathic pulmonary fibrosis

Dalapati,

Wang,

Jones

et al. 2024

Preprint

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SUMMARYMost genetic variants identified through genome-wide association studies (GWAS) are suspected to be regulatory in nature, but only a small fraction colocalize with expression quantitative trait loci (eQTLs, variants associated with expression of a gene). Therefore, it is hypothesized but largely untested that integration of disease GWAS with context-specific eQTLs will reveal the underlying genes driving disease associations. We used colocalization and transcriptomic analyses to identify shared genetic variants and likely causal genes associated with critically ill COVID-19 and idiopathic pulmonary fibrosis. We first identified five genome-wide significant variants associated with both diseases. Four of the variants did not demonstrate clear colocalization between GWAS and healthy lung eQTL signals. Instead, two of the four variants colocalized only in cell-type and disease-specific eQTL datasets. These analyses pointed to higherATP11Aexpression from the C allele of rs12585036, in monocytes and in lung tissue from primarily smokers, which increased risk of IPF and decreased risk of critically ill COVID-19. We also found lowerDPP9expression (and higher methylation at a specific CpG) from the G allele of rs12610495, acting in fibroblasts and in IPF lungs, and increased risk of IPF and critically ill COVID-19. We further found differential expression of the identified causal genes in diseased lungs when compared to non-diseased lungs, specifically in epithelial and immune cell types. These findings highlight the power of integrating GWAS, context-specific eQTLs, and transcriptomics of diseased tissue to harness human genetic variation to identify causal genes and where they function during multiple diseases.

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Analysis of spontaneous reports of suspected adverse reactions after vaccination against COVID-19 in Slovakia

Cited by 5 publications

References 16 publications

Three doses of a recombinant conjugated SARS-CoV-2 vaccine early after allogeneic hematopoietic stem cell transplantation: predicting indicators of a high serologic response—a prospective, single-arm study

Three doses of a recombinant conjugated SARS-CoV-2 vaccine early after allogeneic hematopoietic stem cell transplantation: predicting indicators of a high serologic response—a prospective, single-arm study

Targeting mevalonate pathway by zoledronate ameliorated pulmonary fibrosis in a rat model: Promising therapy against post‐COVID‐19 pulmonary fibrosis

Context-specific eQTLs reveal causal genes underlying shared genetic architecture of critically ill COVID-19 and idiopathic pulmonary fibrosis

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