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  1. Article ; Online: Decidualized human decidual stromal cells inhibit chemotaxis of activated T cells: a potential mechanism of maternal-fetal immune tolerance.

    Llorca, Tatiana / Ruiz-Magaña, Maria Jose / Martinez-Aguilar, Rocio / García-Valdeavero, Olga María / Rodríguez-Doña, Lucia / Abadia-Molina, Ana Clara / Ruiz-Ruiz, Carmen / Olivares, Enrique G

    Frontiers in immunology

    2023  Volume 14, Page(s) 1223539

    Abstract: ... T cells in the decidua. ...

    Abstract Background: Numerous lines of evidence confirm that decidual stromal cells (DSCs) play a key role in maternal-fetal immune tolerance. Under the influence of progesterone and other hormones, the DSCs go through a process of differentiation (decidualization) during normal pregnancy. In mice, DSCs inhibit the expression of chemokines that attract abortigenic Th1 and Tc cells to the decidua. We have studied this phenomenon in humans.
    Methods: We established human DSC lines and decidualized these cells
    Results: We demonstrated that
    Discussion: These results confirm in humans that decidualization of DSCs inhibits the expression by these cells of chemokines that attract Th1 and Tc cells and induces the secretion by DSCs of factors that inhibit the chemotaxis of these lymphocytes, thus preventing the arrival of abortigenic T cells in the decidua.
    MeSH term(s) Female ; Pregnancy ; Humans ; Animals ; Mice ; Chemotaxis ; Culture Media, Conditioned ; Progesterone ; Fetus ; CD8-Positive T-Lymphocytes
    Chemical Substances Culture Media, Conditioned ; Progesterone (4G7DS2Q64Y)
    Language English
    Publishing date 2023-08-23
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2023.1223539
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Improved quantitation of short-chain carboxylic acids in human biofluids using 3-nitrophenylhydrazine derivatization and liquid chromatography with tandem mass spectrometry (LC-MS/MS).

    Valdivia-Garcia, Maria A / Chappell, Katie E / Camuzeaux, Stephane / Olmo-García, Lucía / van der Sluis, Verena Horneffer / Radhakrishnan, Shiva T / Stephens, Hannah / Bouri, Sonia / de Campos Braz, Lucia M / Williams, Horace T / Lewis, Matthew R / Frost, Gary / Li, Jia V

    Journal of pharmaceutical and biomedical analysis

    2022  Volume 221, Page(s) 115060

    Abstract: Short-chain carboxylic acids (SCCAs) produced by gut microbial fermentation may reflect gastrointestinal health. Their concentrations in serum and urine are indicative of specific metabolic pathway activity; therefore, accurate quantitation of SCCAs in ... ...

    Abstract Short-chain carboxylic acids (SCCAs) produced by gut microbial fermentation may reflect gastrointestinal health. Their concentrations in serum and urine are indicative of specific metabolic pathway activity; therefore, accurate quantitation of SCCAs in different biofluids is desirable. However, it is often challenging to quantitate SCCAs since matrix effects, induced by the presence of a vast variety of other compounds other than SCCAs in complex biofluids, can suppress or enhance signals. Materials used for sample preparation may introduce further analytical challenges. This study reports for the first time a LC-MS/MS-based method to quantitate ten SCCAs (lactate, acetate, 2-hydroxybutyrate, propionate, isobutyrate, butyrate, 2-methylbutyrate, isovalerate, valerate and hexanoate) and evaluates the matrix effects in five human biofluids: serum, urine, stool, and contents from the duodenum and intestinal stoma bags. The optimized method, using 3-Nitrophenylhydrazone as a derivatization agent and a Charge Surface Hybrid reverse phase column, showed clear separation for all SCCAs at a concentration range of 0.1-100 µM, in a 10.5 min run without carry-over effects. The validation of the method showed a good linearity (R2 > 0.99), repeatability (CV ≤ 15%) assessed by intra- and inter-day monitoring. The lowest limit of detection (LLOD) was 25 nM and lowest limit of quantitation (LLOQ) was 50 nM for nine SCCA except acetate at 0.5 and 1 µM, respectively. Quantitative accuracy in all biofluids for most compounds was < ±15%. In summary, this methodology has the advantages over other techniques for its simple and fast sample preparation and a high level of selectivity, repeatability and robustness for SCCA quantification. It also reduced interferences from the matrix or sample containers, making it ideal for use in high-throughput analyses of biofluid samples from large-scale studies.
    MeSH term(s) Caproates ; Carboxylic Acids ; Chromatography, High Pressure Liquid/methods ; Chromatography, Liquid/methods ; Humans ; Hydroxybutyrates ; Isobutyrates ; Lactates ; Phenylhydrazines ; Propionates ; Tandem Mass Spectrometry/methods ; Valerates
    Chemical Substances 3-nitrophenylhydrazine ; Caproates ; Carboxylic Acids ; Hydroxybutyrates ; Isobutyrates ; Lactates ; Phenylhydrazines ; Propionates ; Valerates
    Language English
    Publishing date 2022-09-15
    Publishing country England
    Document type Journal Article
    ZDB-ID 604917-5
    ISSN 1873-264X ; 0731-7085
    ISSN (online) 1873-264X
    ISSN 0731-7085
    DOI 10.1016/j.jpba.2022.115060
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  3. Article ; Online: SARS-CoV-2-reactive antibody waning, booster effect and breakthrough SARS-CoV-2 infection in hematopoietic stem cell transplant and cell therapy recipients at one year after vaccination.

    Piñana, José Luis / Martino, Rodrigo / Vazquez, Lourdes / López-Corral, Lucia / Pérez, Ariadna / Chorão, Pedro / Avendaño-Pita, Alejandro / Pascual, María-Jesús / Sánchez-Salinas, Andrés / Sanz-Linares, Gabriela / Olave, María T / Arroyo, Ignacio / Tormo, Mar / Villalon, Lucia / Conesa-Garcia, Venancio / Gago, Beatriz / Terol, María-José / Villalba, Marta / Garcia-Gutierrez, Valentín /
    Cabero, Almudena / Hernández-Rivas, José Ángel / Ferrer, Elena / García-Cadenas, Irene / Teruel, Anabel / Navarro, David / Cedillo, Ángel / Sureda, Anna / Solano, Carlos

    Bone marrow transplantation

    2023  Volume 58, Issue 5, Page(s) 567–580

    Abstract: ... and autologous stem cell transplantation (allo-HSCT, ASCT) and chimeric antigen receptor T-cell ... therapy (CAR-T) are of utmost importance for estimating risk of infection. A prospective multicenter ... recipients (429 allo-HSCT, 121 ASCT and 22 CAR-T cell therapy). A significant decline in antibody titers was ...

    Abstract The kinetics of SARS-CoV-2 reactive IgG antibodies after full vaccination and booster in allogeneic and autologous stem cell transplantation (allo-HSCT, ASCT) and chimeric antigen receptor T-cell therapy (CAR-T) are of utmost importance for estimating risk of infection. A prospective multicenter registry-based cohort study, conducted from December 2020 to July 2022 was used to analyze antibody waning over time, booster effect and the relationship of antibody response and breakthrough infection in 572 recipients (429 allo-HSCT, 121 ASCT and 22 CAR-T cell therapy). A significant decline in antibody titers was observed at 3 and 6 months after full vaccination in recipients without pre-vaccine SARS-CoV-2 infection, whereas recipients infected prior to vaccination showed higher and stable antibody titers over time. In poor responders, a booster dose was able to increase antibody titers in 83% of allo-HSCT and 58% of ASCT recipients but not in CART-T cell recipients [0%] (p < 0.01). One-year cumulative incidence of breakthrough infection was 15%, similar among cell therapy procedures. Immunosuppressive drugs at the time of vaccination [hazard ratio (HR) 1.81, p = 0.0028] and reduced intensity conditioning (HR 0.49, p = 0.011) were identified as the only conditions associated with different risk of breakthrough infection in allo-HSCT recipients. Antibody titers were associated with breakthrough infection and disease severity. No death was observed among the 72 breakthrough infections. Antibody level decay after the first two vaccine doses was common except in recipients with pre-vaccination SARS-CoV-2 infection. Poorly responding allo-HSCT recipients showed a response advantage with the booster as compared to ASCT and, especially, the null response found in CAR-T cell recipients. Antibody titers were positively correlated with the risk of breakthrough SARS-CoV-2 infection which was mainly driven by the immunosuppression status.
    MeSH term(s) Humans ; SARS-CoV-2 ; Hematopoietic Stem Cell Transplantation ; Cohort Studies ; Prospective Studies ; Receptors, Chimeric Antigen ; Transplantation, Autologous ; COVID-19 ; Antibodies, Viral ; Vaccination ; Breakthrough Infections ; Cell- and Tissue-Based Therapy ; Transplant Recipients
    Chemical Substances Receptors, Chimeric Antigen ; Antibodies, Viral
    Language English
    Publishing date 2023-02-28
    Publishing country England
    Document type Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632854-4
    ISSN 1476-5365 ; 0268-3369 ; 0951-3078
    ISSN (online) 1476-5365
    ISSN 0268-3369 ; 0951-3078
    DOI 10.1038/s41409-023-01946-0
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  4. Article ; Online: One-year breakthrough SARS-CoV-2 infection and correlates of protection in fully vaccinated hematological patients.

    Piñana, José Luis / Vazquez, Lourdes / Calabuig, Marisa / López-Corral, Lucia / Martin-Martin, Gabriel / Villalon, Lucia / Sanz-Linares, Gabriela / Conesa-Garcia, Venancio / Sanchez-Salinas, Andrés / Gago, Beatriz / Facal, Ana / Risco-Gálvez, Irene / Olave, María T / Espigado, Ildefonso / Lopez-Jimenez, Javier / Hernández-Rivas, José Ángel / Avendaño-Pita, Alejandro / Arroyo, Ignacio / Ferrer, Elena /
    García-Cadenas, Irene / González-Santillana, Clara / Roldán-Pérez, Alicia / Ferrer, Blanca / Guerreiro, Manuel / Suarez-Lledó, María / Camara, Angela / Campos-Beltrán, Diana / Navarro, David / Cedillo, Ángel / Sureda, Anna / Solano, Carlos / Martino, Rodrigo

    Blood cancer journal

    2023  Volume 13, Issue 1, Page(s) 8

    Abstract: The long-term clinical efficacy of SARS-CoV-2 vaccines according to antibody response in immunosuppressed patients such as hematological patients has been little explored. A prospective multicenter registry-based cohort study conducted from December 2020 ...

    Abstract The long-term clinical efficacy of SARS-CoV-2 vaccines according to antibody response in immunosuppressed patients such as hematological patients has been little explored. A prospective multicenter registry-based cohort study conducted from December 2020 to July 2022 by the Spanish Transplant and Cell Therapy group, was used to analyze the relationship of antibody response over time after full vaccination (at 3-6 weeks, 3, 6 and 12 months) (2 doses) and of booster doses with breakthrough SARS-CoV-2 infection in 1551 patients with hematological disorders. At a median follow-up of 388 days after complete immunization, 266 out of 1551 (17%) developed breakthrough SARS-CoV-2 infection at median of 86 days (range 7-391) after full vaccination. The cumulative incidence was 18% [95% confidence interval (C.I.), 16-20%]. Multivariate analysis identified higher incidence in chronic lymphocytic leukemia patients (29%) and with the use of corticosteroids (24.5%), whereas female sex (15.5%) and more than 1 year after last therapy (14%) were associated with a lower incidence (p < 0.05 for all comparisons). Median antibody titers at different time points were significantly lower in breakthrough cases than in non-cases. A serological titer cut-off of 250 BAU/mL was predictive of breakthrough infection and its severity. SARS-CoV-2 infection-related mortality was encouragingly low (1.9%) in our series. Our study describes the incidence of and risk factors for COVID-19 breakthrough infections during the initial vaccination and booster doses in the 2021 to mid-2022 period. The level of antibody titers at any time after 2-dose vaccination is strongly linked with protection against both breakthrough infection and severe disease, even with the Omicron SARS-CoV-2 variant.
    MeSH term(s) Humans ; Female ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines ; SARS-CoV-2 ; Cohort Studies ; Prospective Studies
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2023-01-05
    Publishing country United States
    Document type Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2600560-8
    ISSN 2044-5385 ; 2044-5385
    ISSN (online) 2044-5385
    ISSN 2044-5385
    DOI 10.1038/s41408-022-00778-3
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  5. Article ; Online: Plasma Extracellular Vesicles Play a Role in Immune System Modulation in Minimal Hepatic Encephalopathy.

    Gallego, Juan José / Fiorillo, Alessandra / Casanova-Ferrer, Franc / Urios, Amparo / Ballester, María-Pilar / Durbán, Lucia / Megías, Javier / Rubio, Teresa / Cabrera-Pastor, Andrea / Escudero-García, Desamparados / Felipo, Vicente / Montoliu, Carmina

    International journal of molecular sciences

    2022  Volume 23, Issue 20

    Abstract: ... an increased pro-inflammatory environment and altered differentiation of CD4+ T lymphocytes. The mechanisms ... differentiation of CD4+ T lymphocyte subtypes in MHE patients. We characterized the miRNA and protein cargo ... of plasma EVs from 50 cirrhotic patients (27 without and 23 with MHE) and 24 controls. CD4+ T ...

    Abstract Minimal hepatic encephalopathy (MHE) is associated with changes in the immune system including an increased pro-inflammatory environment and altered differentiation of CD4+ T lymphocytes. The mechanisms remain unknown. Changes in extracellular vesicle (EV) cargo including proteins and miRNAs could play a main role as mediators of immune system changes associated with MHE. The aim was to assess whether plasma EVs from MHE patients played a role in inducing the pro-inflammatory environment and altered differentiation of CD4+ T lymphocyte subtypes in MHE patients. We characterized the miRNA and protein cargo of plasma EVs from 50 cirrhotic patients (27 without and 23 with MHE) and 24 controls. CD4+ T cells from the controls were cultured with plasma EVs from the three groups of study, and the cytokine release and differentiation to CD4+ T-cell subtypes were assessed. Plasma EVs from MHE patients had altered miRNA and protein contents, and were enriched in inflammatory factors compared to the controls and patients without MHE. EVs from MHE patients modulated the expression of pro-inflammatory IL-17, IL-21, and TNF-α and anti-inflammatory TGF-β in cultured CD4+ T lymphocytes, and increased the proportion of Th follicular and Treg cells and the activation of Th17 cells. In conclusion, plasma EVs could play an important role in the induction of immune changes observed in MHE.
    MeSH term(s) Humans ; Hepatic Encephalopathy ; Interleukin-17/metabolism ; Tumor Necrosis Factor-alpha/metabolism ; Extracellular Vesicles/metabolism ; Cytokines/metabolism ; T-Lymphocytes, Helper-Inducer ; MicroRNAs/genetics ; MicroRNAs/metabolism ; Transforming Growth Factor beta/metabolism ; Liver Cirrhosis/metabolism
    Chemical Substances Interleukin-17 ; Tumor Necrosis Factor-alpha ; Cytokines ; MicroRNAs ; Transforming Growth Factor beta
    Language English
    Publishing date 2022-10-15
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2019364-6
    ISSN 1422-0067 ; 1422-0067 ; 1661-6596
    ISSN (online) 1422-0067
    ISSN 1422-0067 ; 1661-6596
    DOI 10.3390/ijms232012335
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  6. Article: Interobserver Reliability and Sensitivity to Change of a Composite Ocular Inflammatory Activity Index: UVEDAI

    Pato-Cour, Esperanza / Borrego-Sanz, Lara / Domínguez-Álvaro, Marta / Sánchez-Alonso, Fernando / Rodríguez-González, Fayna / Tejera-Santana, Marta / Esteban-Ortega, Mar / García-Lozano, Isabel / Martínez-Costa, Lucia / González-Ocampo, Samuel / Sainz-de-la-Maza, Maite / Moll-Udina, Aina / Plaza, Zulema / Fonollosa, Alejandro / Artaraz, Joseba / Díaz-Valle, Teresa / Gurrea-Almela, Maria / Díaz-Valle, David / Méndez-Fernández, Rosalía

    Ophthalmology and therapy

    2024  Volume 13, Issue 6, Page(s) 1669–1682

    Abstract: ... The mean change between both measures was compared using the repeated-measures t-test.: Results: A total ...

    Abstract Introduction: This was a multicenter, prospective, longitudinal, observational study involving eight Spanish tertiary hospitals to determine the interobserver reliability of an uveitis disease activity index, (UVEDAI) and assess its sensitivity to change in patients with receiving pharmacologic treatment.
    Methods: Patients aged ≥ 18 years diagnosed with active noninfectious uveitis were included. A complete baseline assessment was performed by two ophthalmologists who determined ocular inflammatory activity using the UVEDAI index independently of each other. The principal ophthalmologist made a new visit at 4 weeks to determine the change in inflammatory activity. The interobserver reliability analysis was performed by calculating the intraclass correlation coefficient (ICC), with the values of the variables and the UVEDAI obtained by both ophthalmologists in the more active eye at the baseline visit. Sensitivity to change in the UVEDAI index was assessed at 4 weeks from the start of pharmacologic treatment by determining the clinically relevant change, defined as a change in UVEDAI of ≥ 0.8 points over baseline. The mean change between both measures was compared using the repeated-measures t-test.
    Results: A total of 111 patients were included. In the interobserver reliability analysis, the ICC for the UVEDAI value was 0.9, and, when compared with the mean UVEDAI values obtained by the ophthalmologists, no statistically significant differences were found (p value > 0.05). As for the sensitivity to change in UVEDAI, statistically significant differences (p value = 0.00) were found for the mean values of the index compared with baseline. In all cases, the index value decreased by > 1 point at the 4-week visit.
    Conclusions: The interobserver reliability of the UVEDAI was high in the total sample. Furthermore, the index was sensitive in determining the change in inflammatory activity after treatment. We believe that UVEDAI is a disease activity index that enables objective comparison of results in clinical practice and trials.
    Language English
    Publishing date 2024-04-18
    Publishing country England
    Document type Journal Article
    ISSN 2193-8245
    ISSN 2193-8245
    DOI 10.1007/s40123-024-00943-w
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  7. Article ; Online: Association between use of enhanced recovery after surgery protocols and postoperative complications after gastric surgery for cancer (POWER 4): a nationwide, prospective multicentre study.

    Ripollés-Melchor, Javier / Abad-Motos, Ane / Bruna-Esteban, Marcos / García-Nebreda, María / Otero-Martínez, Isabel / Abdel-Lah Fernández, Omar / Tormos-Pérez, María P / Paseiro-Crespo, Gloria / García-Álvarez, Raquel / A Mayo-Ossorio, María / Zugasti-Echarte, Orreaga / Nespereira-García, Paula / Gil-Gómez, Lucia / Logroño-Ejea, Margarita / Risco, Raquel / Parreño-Manchado, Felipe C / Gil-Trujillo, Silvia / Benito, Carmen / Jericó, Carlos /
    De-Miguel-Cabrera, María I / Ugarte-Sierra, Bakarne / Barragán-Serrano, Cristina / García-Erce, José A / Muñoz-Hernández, Henar / Río-Fernández, Sabela Del- / Herrero-Bogajo, María L / Espinosa-Moreno, Alma M / Concepción-Martín, Vanessa / Zorrilla-Vaca, Andrés / Vaquero-Pérez, Laura / Mojarro, Irene / Llácer-Pérez, Manuel / Gómez-Viana, Leticia / Fernández-Martín, María T / Abad-Gurumeta, Alfredo / Ferrando-Ortolà, Carlos / Ramírez-Rodríguez, José M / Aldecoa, César

    Cirugia espanola

    2023  Volume 101, Issue 10, Page(s) 665–677

    Abstract: Introduction: The effectiveness of the Enhanced Recovery After Surgery (ERAS) protocols in gastric cancer surgery remains controversial.: Methods: Multicentre prospective cohort study of adult patients undergoing surgery for gastric cancer. Adherence ...

    Abstract Introduction: The effectiveness of the Enhanced Recovery After Surgery (ERAS) protocols in gastric cancer surgery remains controversial.
    Methods: Multicentre prospective cohort study of adult patients undergoing surgery for gastric cancer. Adherence with 22 individual components of ERAS pathways were assessed in all patients, regardless of whether they were treated in a self-designed ERAS centre. Each centre had a three-month recruitment period between October 2019 and September 2020. The primary outcome was moderate-to-severe postoperative complications within 30 days after surgery. Secondary outcomes were overall postoperative complications, adherence to the ERAS pathway, 30 day-mortality and hospital length of stay (LOS).
    Results: A total of 743 patients in 72 Spanish hospitals were included, 211 of them (28.4 %) from self-declared ERAS centres. A total of 245 patients (33 %) experienced postoperative complications, graded as moderate-to-severe complications in 172 patients (23.1 %). There were no differences in the incidence of moderate-to-severe complications (22.3% vs. 23.5%; OR, 0.92 (95% CI, 0.59 to 1.41); P = 0.068), or overall postoperative complications between the self-declared ERAS and non-ERAS groups (33.6% vs. 32.7%; OR, 1.05 (95 % CI, 0.70 to 1.56); P = 0.825). The overall rate of adherence to the ERAS pathway was 52% [IQR 45 to 60]. There were no differences in postoperative outcomes between higher (Q1, > 60 %) and lower (Q4, ≤ 45 %) ERAS adherence quartiles.
    Conclusions: Neither the partial application of perioperative ERAS measures nor treatment in self-designated ERAS centres improved postoperative outcomes in patients undergoing gastric surgery for cancer.
    Trial registration: ClinicalTrials.gov Identifier NCT03865810.
    MeSH term(s) Adult ; Humans ; Enhanced Recovery After Surgery ; Perioperative Care ; Postoperative Complications/epidemiology ; Postoperative Complications/etiology ; Prospective Studies ; Stomach Neoplasms/surgery ; Stomach Neoplasms/complications
    Language English
    Publishing date 2023-04-23
    Publishing country Spain
    Document type Journal Article ; Multicenter Study
    ISSN 2173-5077
    ISSN (online) 2173-5077
    DOI 10.1016/j.cireng.2023.04.011
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  8. Article ; Online: Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial.

    Vanni, Tazio / Thomé, Beatriz C / Sparrow, Erin / Friede, Martin / Fox, Christopher B / Beckmann, Anna Marie / Huynh, Chuong / Mondini, Gabriella / Silveira, Daniela H / Viscondi, Juliana Y K / Braga, Patrícia Emilia / Silva, Anderson da / Salomão, Maria da Graça / Piorelli, Roberta O / Santos, Joane P / Gattás, Vera Lúcia / Lucchesi, Maria Beatriz B / Oliveira, Mayra M M de / Koike, Marcelo E /
    Kallas, Esper G / Campos, Lucia M A / Coelho, Eduardo B / Siqueira, Marilda A M / Garcia, Cristiana C / Miranda, Milene Dias / Paiva, Terezinha M / Timenetsky, Maria do Carmo S T / Adami, Eduardo A / Akamatsu, Milena A / Ho, Paulo Lee / Precioso, Alexander R

    PloS one

    2022  Volume 17, Issue 10, Page(s) e0274943

    Abstract: The emergence of potentially pandemic viruses has resulted in preparedness efforts to develop candidate vaccines and adjuvant formulations. We evaluated the dose-sparing effect and safety of two distinct squalene-based oil-in-water adjuvant emulsion ... ...

    Abstract The emergence of potentially pandemic viruses has resulted in preparedness efforts to develop candidate vaccines and adjuvant formulations. We evaluated the dose-sparing effect and safety of two distinct squalene-based oil-in-water adjuvant emulsion formulations (IB160 and SE) with influenza A/H7N9 antigen. This phase I, randomized, double-blind, placebo-controlled, dose-finding trial (NCT03330899), enrolled 432 healthy volunteers aged 18 to 59. Participants were randomly allocated to 8 groups: 1A) IB160 + 15μg H7N9, 1B) IB160 + 7.5μg H7N9, 1C) IB160 + 3.75μg H7N9, 2A) SE + 15μg H7N9, 2B) SE + 7.5μg H7N9, 2C) SE + 3.75μg H7N9, 3) unadjuvanted vaccine 15μg H7N9 and 4) placebo. Immunogenicity was evaluated through haemagglutination inhibition (HI) and microneutralization (MN) tests. Safety was evaluated by monitoring local and systemic, solicited and unsolicited adverse events (AE) and reactions (AR) 7 and 28 days after each study injection, respectively, whereas serious adverse events (SAE) were monitored up to 194 days post-second dose. A greater increase in antibody geometric mean titers (GMT) was observed in groups receiving adjuvanted vaccines. Vaccinees receiving IB160-adjuvanted formulations showed the greatest response in group 1B, which induced an HI GMT increase of 4.7 times, HI titers ≥40 in 45.2% of participants (MN titers ≥40 in 80.8%). Vaccinees receiving SE-adjuvanted vaccines showed the greatest response in group 2A, with an HI GMT increase of 2.5 times, HI titers ≥40 in 22.9% of participants (MN titers ≥40 in 65.7%). Frequencies of AE and AR were similar among groups. Pain at the administration site and headache were the most frequent local and systemic solicited ARs. The vaccine candidates were safe and the adjuvanted formulations have a potential dose-sparing effect on immunogenicity against influenza A/H7N9. The magnitude of this effect could be further explored.
    MeSH term(s) Humans ; Influenza, Human ; Squalene ; Influenza A Virus, H7N9 Subtype ; Influenza Vaccines ; Pandemics/prevention & control ; Polysorbates ; Emulsions ; Antibodies, Viral ; Hemagglutination Inhibition Tests ; Adjuvants, Immunologic ; Adjuvants, Pharmaceutic ; Water
    Chemical Substances Squalene (7QWM220FJH) ; Influenza Vaccines ; Polysorbates ; Emulsions ; Antibodies, Viral ; Adjuvants, Immunologic ; Adjuvants, Pharmaceutic ; Water (059QF0KO0R)
    Language English
    Publishing date 2022-10-18
    Publishing country United States
    Document type Randomized Controlled Trial ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0274943
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  9. Article: Correction to: Validation of UVEDAI: An Index for Evaluating the Level of Inflammatory Activity in Uveitis.

    Pato-Cour, Esperanza / Martin-Martinez, Mª Auxiliadora / Borrego-Sanz, Lara / Martinez-Costa, Lucia / Esteban-Ortega, Mar / Sánchez-Costa, Jesús T / Cordero-Coma, Miguel / Fonollosa, Alejandro / Diaz-Valle, Teresa / Rodríguez-González, Fayna / Sainz-de-la-Maza, Maite / Diaz-Valle, David / Gonzalez-Ocampo, Samuel / López-Sierra, Sara / Garcia-Lozano, Isabel / Garzo-García, Irene / Artaraz, Joseba / Gurrea-Almela, Maria / Tejera, Marta /
    Moll-Udina, Aina / Valls-Pascual, Elia / Muñoz-Fernández, Santiago / Méndez-Fernandez, Rosalía

    Ophthalmology and therapy

    2023  Volume 12, Issue 2, Page(s) 1057–1058

    Language English
    Publishing date 2023-02-17
    Publishing country England
    Document type Published Erratum
    ISSN 2193-8245
    ISSN 2193-8245
    DOI 10.1007/s40123-023-00681-5
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  10. Article ; Online: Applicability of probabilistic graphical models for early detection of SARS-CoV-2 reactive antibodies after SARS-CoV-2 vaccination in hematological patients.

    Piñana, José Luis / Rodríguez-Belenguer, Pablo / Caballero, Dolores / Martino, Rodrigo / Lopez-Corral, Lucia / Terol, María-José / Vazquez, Lourdes / Calabuig, Marisa / Sanz-Linares, Gabriela / Marin-Jimenez, Francisca / Alonso, Carmen / Montoro, Juan / Ferrer, Elena / Facal, Ana / Pascual, María-Jesús / Rodriguez-Fernandez, Alicia / Olave, María T / Cascales-Hernandez, Almudena / Gago, Beatriz /
    Hernández-Rivas, José-Ángel / Villalon, Lucia / Corona, Magdalena / Roldán-Pérez, Alicia / Ribes-Amoros, Julia / González-Santillana, Clara / Garcia-Sanz, Ramon / Navarro, David / Serrano-López, Antonio J / Cedillo, Ángel / Soria-Olivas, Emilio / Sureda, Anna / Solano, Carlos

    Annals of hematology

    2022  Volume 101, Issue 9, Page(s) 2053–2067

    Abstract: Prior studies of antibody response after full SARS-CoV-2 vaccination in hematological patients have confirmed lower antibody levels compared to the general population. Serological response in hematological patients varies widely according to the disease ... ...

    Abstract Prior studies of antibody response after full SARS-CoV-2 vaccination in hematological patients have confirmed lower antibody levels compared to the general population. Serological response in hematological patients varies widely according to the disease type and its status, and the treatment given and its timing with respect to vaccination. Through probabilistic machine learning graphical models, we estimated the conditional probabilities of having detectable anti-SARS-CoV-2 antibodies at 3-6 weeks after SARS-CoV-2 vaccination in a large cohort of patients with several hematological diseases (n= 1166). Most patients received mRNA-based vaccines (97%), mainly Moderna® mRNA-1273 (74%) followed by Pfizer-BioNTech® BNT162b2 (23%). The overall antibody detection rate at 3 to 6 weeks after full vaccination for the entire cohort was 79%. Variables such as type of disease, timing of anti-CD20 monoclonal antibody therapy, age, corticosteroids therapy, vaccine type, disease status, or prior infection with SARS-CoV-2 are among the most relevant conditions influencing SARS-CoV-2-IgG-reactive antibody detection. A lower probability of having detectable antibodies was observed in patients with B-cell non-Hodgkin's lymphoma treated with anti-CD20 monoclonal antibodies within 6 months before vaccination (29.32%), whereas the highest probability was observed in younger patients with chronic myeloproliferative neoplasms (99.53%). The Moderna® mRNA-1273 compound provided higher probabilities of antibody detection in all scenarios. This study depicts conditional probabilities of having detectable antibodies in the whole cohort and in specific scenarios such as B cell NHL, CLL, MM, and cMPN that may impact humoral responses. These results could be useful to focus on additional preventive and/or monitoring interventions in these highly immunosuppressed hematological patients.
    MeSH term(s) Antibodies, Monoclonal ; Antibodies, Viral ; Antineoplastic Agents ; BNT162 Vaccine ; COVID-19/diagnosis ; COVID-19/prevention & control ; COVID-19 Vaccines ; Early Detection of Cancer ; Humans ; SARS-CoV-2 ; Vaccination
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Viral ; Antineoplastic Agents ; COVID-19 Vaccines ; BNT162 Vaccine (N38TVC63NU)
    Language English
    Publishing date 2022-07-02
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1064950-5
    ISSN 1432-0584 ; 0939-5555 ; 0945-8077
    ISSN (online) 1432-0584
    ISSN 0939-5555 ; 0945-8077
    DOI 10.1007/s00277-022-04906-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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