Single-arm, multicenter phase I/II clinical trial for the treatment of envenomings by massive africanized honey bee stings using the unique apilic antivenom

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dc.contributorLab. Bioquímicapt_BR
dc.contributor.authorBarbosa, Alexandre Naimept_BR
dc.contributor.authorFerreira Jr, Rui Seabrapt_BR
dc.contributor.authorCarvalho, Francilene Capel Tavares dept_BR
dc.contributor.authorSchuelter-Trevisol, Fabianapt_BR
dc.contributor.authorMendes, Mônica Bannwartpt_BR
dc.contributor.authorMendonça, Bruna Caveccipt_BR
dc.contributor.authorBatista, José Nixonpt_BR
dc.contributor.authorTrevisol, Daisson Josépt_BR
dc.contributor.authorBoyer, Lesliept_BR
dc.contributor.authorChippaux, Jean-Philippept_BR
dc.contributor.authorMedolago, Natália Bronzattopt_BR
dc.contributor.authorCassaro, Claudia Vilalvapt_BR
dc.contributor.authorCarneiro, Márcia Tonin Rigottopt_BR
dc.contributor.authorOliveira, Ana Paola Piloto dept_BR
dc.contributor.authorPimenta, Daniel Carvalhopt_BR
dc.contributor.authorCunha, Luís Eduardo Ribeiro dapt_BR
dc.contributor.authorSantos, Lucilene Delazari dospt_BR
dc.contributor.authorBarraviera, Beneditopt_BR
dc.date.accessioned2021-04-13T15:04:18Z-
dc.date.available2021-04-13T15:04:18Z-
dc.date.issued2021pt_BR
dc.identifier.citationBarbosa AN, Ferreira Jr RS, Carvalho FCT, Schuelter-Trevisol F, Mendes MB, Mendonça BC, et al. Single-arm, multicenter phase I/II clinical trial for the treatment of envenomings by massive africanized honey bee stings using the unique apilic antivenom. Front Immunol. 2021 Mar;12. doi:10.3389/fimmu.2021.653151.pt_BR
dc.identifier.urihttps://repositorio.butantan.gov.br/handle/butantan/3665-
dc.description.abstractWe evaluated the safety, optimal dose, and preliminary effectiveness of a new-approach Africanized honeybee (Apis mellifera) Antivenom (AAV) in a phase I/II, multicenter, non-randomized, single-arm clinical trial involving 20 participants with multiple stings. Participants received 2 to 10 vials of AAV depending on the number of stings they suffered, or a predefined adjuvant, symptomatic, and complementary treatment. The primary safety endpoint was the occurrence of early adverse reactions within the first 24 h of treatment. Preliminary efficacy based on clinical evolution, including laboratory findings, was assessed at baseline and at various time points over the four following weeks. ELISA assays and mass spectrometry were used to estimate venom pharmacokinetics before, during, and after treatment. Twenty adult participants, i.e., 13 (65%) men and 7 (35%) women, with a median age of 44 years and a mean body surface area of 1.92 m2 (median = 1.93 m2) were recruited. The number of stings ranged from 7 to > 2,000, with a median of 52.5. Symptoms of envenoming were classified as mild, moderate, or severe in 80% (16), 15% (3), and 5% (1) of patients, respectively; patients with mild, moderate, or severe envenoming received 2, 6, and 10 vials of AAV as per the protocol. None of the patients had late reactions (serum sickness) within 30 d of treatment. There was no discontinuation of the protocol due to adverse events, and there were no serious adverse events. One patient had a moderate adverse event, transient itchy skin, and erythroderma. All participants completed the intravenous antivenom infusion within 2 h, and there was no loss to follow-up after discharge. ELISA assays showed venom (melittin and PLA2) concentrations varying between 0.25 and 1.479 ng/mL prior to treatment. Venom levels decreased in all patients during the hospitalization period. Surprisingly, in nine cases (45%), despite clinical recovery and the absence of symptoms, venom levels increased again during outpatient care 10 d after discharge. Mass spectrometry showed melittin in eight participants, 30 d after treatment. Considering the promising safety results for this investigational product in the treatment of massive Africanized honeybee attack, and its efficacy, reflected in the clinical improvements and corresponding immediate decrease in blood venom levels, the AAV has shown to be safe for human use. Clinical Trial Registration: UTN: U1111-1160-7011, identifier [RBR-3fthf8].pt_BR
dc.description.sponsorship(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológicopt_BR
dc.description.sponsorship(CAPES) Coordenação de Aperfeiçoamento de Pessoal de Nível Superiorpt_BR
dc.description.sponsorship(FAPESP) Fundação de Amparo à Pesquisa do Estado de São Paulopt_BR
dc.description.sponsorship(UNESP) Universidade Estadual Paulistapt_BR
dc.format.extent653151pt_BR
dc.language.isoEnglishpt_BR
dc.relation.ispartofFrontiers in Immunologypt_BR
dc.rightsOpen accesspt_BR
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/pt_BR
dc.titleSingle-arm, multicenter phase I/II clinical trial for the treatment of envenomings by massive africanized honey bee stings using the unique apilic antivenompt_BR
dc.typeArticlept_BR
dc.rights.licenseCC BYpt_BR
dc.identifier.doi10.3389/fimmu.2021.653151pt_BR
dc.identifier.urlhttps://doi.org/10.3389/fimmu.2021.653151pt_BR
dc.contributor.external(UNESP) Universidade Estadual Paulista Júlio de Mesquita Filhopt_BR
dc.contributor.externalHospital de Clínicas Nossa Senhora da Conceiçãopt_BR
dc.contributor.external(UNISUL) Universidade do Sul de Santa Catarinapt_BR
dc.contributor.external(NAU) Northern Arizona Universitypt_BR
dc.contributor.externalUniversité Paris-Estpt_BR
dc.contributor.external(IP) Institut Pasteurpt_BR
dc.contributor.externalInstituto Vital Brazilpt_BR
dc.identifier.citationvolume12pt_BR
dc.subject.keywordantivenompt_BR
dc.subject.keywordApis mellifera (Africanized)pt_BR
dc.subject.keywordclinical trialpt_BR
dc.subject.keywordsafety assessmentpt_BR
dc.subject.keywordenzyme-linked immunosorbent assay (ELISA)pt_BR
dc.relation.ispartofabbreviatedFront Immunolpt_BR
dc.identifier.citationabntv. 12, :653151, mar. 2021pt_BR
dc.identifier.citationvancouver2021 Mar;12pt_BR
dc.contributor.butantanPimenta, Daniel Carvalho|:Pesquisador:Docente permanente PPGTOX|:Lab. Bioquímicapt_BR
dc.sponsorship.butantan(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológico¦¦437089/2018-5pt_BR
dc.sponsorship.butantan(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológico¦¦563582/2010-3pt_BR
dc.sponsorship.butantan(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológico¦¦401170/2013-6pt_BR
dc.sponsorship.butantan(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológico¦¦303224/2018-5pt_BR
dc.sponsorship.butantan(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológico¦¦301974/2019-5pt_BR
dc.sponsorship.butantan(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológico¦¦306339/2020-0pt_BR
dc.sponsorship.butantan(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológico¦¦841906/2016-SICONVpt_BR
dc.sponsorship.butantan(CNPq) Conselho Nacional de Desenvolvimento Científico e Tecnológico¦¦841904/2016-SICONVpt_BR
dc.sponsorship.butantan(CAPES) Coordenação de Aperfeiçoamento de Pessoal de Nível Superior¦¦23,038.000823/201121pt_BR
dc.sponsorship.butantan(FAPESP) Fundação de Amparo à Pesquisa do Estado de São Paulo¦¦2020/09819-6pt_BR
dc.sponsorship.butantan(FAPESP) Fundação de Amparo à Pesquisa do Estado de São Paulo¦¦2020/16747-1pt_BR
dc.identifier.bvsccBR78.1pt_BR
dc.identifier.bvsdbIBProdpt_BR
dc.description.dbindexedYespt_BR
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