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      10Scopus© Citations 10
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    Safety and Immunogenicity of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Subgroup of Healthy Adults in Chile
    (2021)
    Susan M Bueno
    ;
    Katia Abarca
    ;
    GONZALEZ, PABLO
    ;
    Nicolás M S Gálvez
    ;
    Jorge A Soto
    <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>The development of effective vaccines against coronavirus disease 2019 is a global priority. CoronaVac is an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine with promising safety and immunogenicity profiles. This article reports safety and immunogenicity results obtained for healthy Chilean adults aged ≥18 years in a phase 3 clinical trial.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Volunteers randomly received 2 doses of CoronaVac or placebo, separated by 2 weeks. A total of 434 volunteers were enrolled, 397 aged 18–59 years and 37 aged ≥60 years. Solicited and unsolicited adverse reactions were registered from all volunteers. Blood samples were obtained from a subset of volunteers and analyzed for humoral and cellular measures of immunogenicity.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>The primary adverse reaction in the 434 volunteers was pain at the injection site, with a higher incidence in the vaccine than in the placebo arm. Adverse reactions observed were mostly mild and local. No severe adverse events were reported. The humoral evaluation was performed on 81 volunteers. Seroconversion rates for specific anti-S1-receptor binding domain (RBD) immunoglobulin G (IgG) were 82.22% and 84.44% in the 18–59 year age group and 62.69% and 70.37% in the ≥60 year age group, 2 and 4 weeks after the second dose, respectively. A significant increase in circulating neutralizing antibodies was detected 2 and 4 weeks after the second dose. The cellular evaluation was performed on 47 volunteers. We detected a significant induction of T-cell responses characterized by the secretion of interferon-γ (IFN-γ) upon stimulation with Mega Pools of peptides from SARS-CoV-2.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Immunization with CoronaVac in a 0–14 schedule in Chilean adults aged ≥18 years is safe, induces anti-S1-RBD IgG with neutralizing capacity, activates T cells, and promotes the secretion of IFN-γ upon stimulation with SARS-CoV-2 antigens.</jats:p> </jats:sec>
    Scopus© Citations 75  1
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    Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial
    (2022)
    Katia Abarca
    ;
    Carolina Iturriaga
    ;
    Marcela Urzúa
    ;
    Nicole Le Corre
    ;
    Augusto Pineda
    <jats:p>Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac®, an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac® in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged ≥60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac® is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.</jats:p>
      1  2Scopus© Citations 9
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    Reactivation of adult-onset Still’s disease after use of the COVID-19 ChAdOx1-S vaccine
    (2022)
    Sebastián E Ibáñez Vodnizza
    ;
    Luis Morales Murillo
    ;
    Matías de la Rivera Vergara
    ;
    Roberto Saldías Martínez
    <jats:p>A woman in her 60s with a history of adult-onset Still’s disease (AOSD) in remission for 14 years received the ChAdOx1-S vaccine as a booster to her initial vaccination schedule (two doses of CoronaVac vaccine 6 months apart). Two weeks later, she consulted for symptoms suggestive of AOSD reactivation. This was confirmed during hospitalisation, where renal and cardiac involvement were also observed. Despite using high-dose corticosteroids, troponin T and N-terminal pro hormone B-type natriuretic peptide (NT-proBNP) were persistently elevated. Tocilizumab was used, with which the patient achieved complete remission of her symptoms and normalised her laboratory tests.</jats:p>
      22Scopus© Citations 4
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    New Pharmacological Strategies for the Treatment of Non-Infectious Uveitis. A Minireview
    (2020)
    Rodrigo A. Valenzuela
    ;
    Iván Flores
    ;
    Beatriz Urrutia
    ;
    Francisca Fuentes
    ;
    Pablo E. Sabat
    Scopus© Citations 28  2
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    Chikungunya, enfermedad emergente en América Latina. Descripción de los primeros casos en Chile
    (2018)
    Cecilia Perret
    ;
    Cecilia Vizcaya
    ;
    WEITZEL, THOMAS  
    ;
    Reinaldo Rosas
    ;
    Jeannette Dabanch
    Scopus© Citations 6  2
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    Scopus© Citations 731  3