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Lancet ; 393(10174): 889-898, 2019 03 02.
Artigo em Inglês | MEDLINE | ID: mdl-30686586


BACKGROUND: mAb114 is a single monoclonal antibody that targets the receptor-binding domain of Ebola virus glycoprotein, which prevents mortality in rhesus macaques treated after lethal challenge with Zaire ebolavirus. Here we present expedited data from VRC 608, a phase 1 study to evaluate mAb114 safety, tolerability, pharmacokinetics, and immunogenicity. METHODS: In this phase 1, dose-escalation study (VRC 608), conducted at the US National Institutes of Health (NIH) Clinical Center (Bethesda, MD, USA), healthy adults aged 18-60 years were sequentially enrolled into three mAb114 dose groups of 5 mg/kg, 25 mg/kg, and 50 mg/kg. The drug was given to participants intravenously over 30 min, and participants were followed for 24 weeks. Participants were only enrolled into increased dosing groups after interim safety assessments. Our primary endpoints were safety and tolerability, with pharmacokinetic and anti-drug antibody assessments as secondary endpoints. We assessed safety and tolerability in all participants who received study drug by monitoring clinical laboratory data and self-report and direct clinician assessment of prespecified infusion-site symptoms 3 days after infusion and systemic symptoms 7 days after infusion. Unsolicited adverse events were recorded for 28 days. Pharmacokinetic and anti-drug antibody assessments were completed in participants with at least 56 days of data. This trial is registered with, number NCT03478891, and is active but no longer recruiting. FINDINGS: Between May 16, and Sept 27, 2018, 19 eligible individuals were enrolled. One (5%) participant was not infused because intravenous access was not adequate. Of 18 (95%) remaining participants, three (17%) were assigned to the 5 mg/kg group, five (28%) to the 25 mg/kg group, and ten (55%) to the 50 mg/kg group, each of whom received a single infusion of mAb114 at their assigned dose. All infusions were well tolerated and completed over 30-37 min with no infusion reactions or rate adjustments. All participants who received the study drug completed the safety assessment of local and systemic reactogenicity. No participants reported infusion-site symptoms. Systemic symptoms were all mild and present only in four (22%) of 18 participants across all dosing groups. No unsolicited adverse events occurred related to mAb114 and one serious adverse event occurred that was unrelated to mAb114. mAb114 has linear pharmacokinetics and a half-life of 24·2 days (standard error of measurement 0·2) with no evidence of anti-drug antibody development. INTERPRETATION: mAb114 was well tolerated, showed linear pharmacokinetics, and was easily and rapidly infused, making it an attractive and deployable option for treatment in outbreak settings. FUNDING: Vaccine Research Center, US National Institute of Allergy and Infectious Diseases, and NIH.

Anticorpos Monoclonais/imunologia , Anticorpos Monoclonais/farmacocinética , Vacinas contra Ebola/imunologia , Ebolavirus/imunologia , Doença pelo Vírus Ebola/imunologia , Fatores Imunológicos/imunologia , Fatores Imunológicos/farmacocinética , Proteínas Virais/imunologia , Administração Intravenosa , Adulto , Animais , Anticorpos Monoclonais/administração & dosagem , Relação Dose-Resposta a Droga , Vacinas contra Ebola/administração & dosagem , Feminino , Doença pelo Vírus Ebola/prevenção & controle , Humanos , Fatores Imunológicos/administração & dosagem , Macaca mulatta , Masculino , Pessoa de Meia-Idade , Adulto Jovem
Children (Basel) ; 5(6)2018 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-29882771


This study examined caregiver perceptions of risk of food allergen exposure, and food allergy severity, worry, and health-related quality of life, and identified variations by race/ethnicity. Given the lack of data on racial/ethnic background in research on the psychosocial impacts of food allergy, this study meets a pressing need for research regarding food allergy-related experiences among diverse populations. This study found there were significant differences in perceived risk of allergen exposure among racial/ethnic groups with Asian Americans reporting significantly higher perceived risk of allergen exposure than Hispanic, Caucasian, and African American caregivers. There were no significant differences in food allergy severity, food allergy worry, or health-related quality of life among racial/ethnic groups; however, variability among racial/ethnic groups was apparent. Data may inform screening, counseling, and education practices for families from diverse backgrounds and aid in hypothesis generation for future research.

Acad Pediatr ; 18(3): 357-359, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29408680


Management of referral and consultation is an entrustable professional activity for pediatric residents; however, few tools exist to teach these skills. We designed and implemented tools to prompt discussion, feedback, and reflection about the process of referral, notably including the family's perspective.

Issue Brief (Commonw Fund) ; 33: 1-12, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24354048


Part of states' roles in administering the new health insurance marketplaces is to certify the health plans available for purchase. This analysis focuses on how state-based and state partnership marketplaces are using their flexibility in setting certification standards to shape plan design in the individual market. It focuses on three aspects of certification: provider networks; inclusion of essential community providers; and benefit substitution, which allows plans to offer benefits that differ from a state's benchmark plan. A review of documents collected from 18 states and the District of Columbia finds that 13 states go beyond the minimum federal requirements with respect to provider network standards, four states specify additional standards for including essential community providers, and five states and Washington, D.C., bar benefit substitution. These interstate variations in plan design reflect the challenges policymakers face in balancing health care affordability, benefit coverage, and access to care through the marketplace plans.

Certificação/legislação & jurisprudência , Reforma dos Serviços de Saúde/legislação & jurisprudência , Trocas de Seguro de Saúde/legislação & jurisprudência , Benefícios do Seguro/legislação & jurisprudência , Seguro Saúde/legislação & jurisprudência , Certificação/normas , Redes Comunitárias/legislação & jurisprudência , Redes Comunitárias/normas , Governo Federal , Reforma dos Serviços de Saúde/normas , Trocas de Seguro de Saúde/normas , Humanos , Benefícios do Seguro/normas , Seguro Saúde/normas , Patient Protection and Affordable Care Act , Governo Estadual , Estados Unidos