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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Autor(es): dc.contributorUniversidade Estadual Paulista (Unesp)-
Autor(es): dc.contributorNossa Senhora da Conceição Hospital-
Autor(es): dc.contributorUniversity of Southern Santa Catarina at Tubarão-
Autor(es): dc.contributorUniversity of Arizona College of Medicine-
Autor(es): dc.contributorUniversité Paris 5-
Autor(es): dc.contributorInstitut Pasteur-
Autor(es): dc.contributorButantan Institute-
Autor(es): dc.contributorVital Brazil Institute-
Autor(es): dc.creatorBarbosa, Alexandre Naime [UNESP]-
Autor(es): dc.creatorFerreira, Rui Seabra [UNESP]-
Autor(es): dc.creatorde Carvalho, Francilene Capel Tavares [UNESP]-
Autor(es): dc.creatorSchuelter-Trevisol, Fabiana-
Autor(es): dc.creatorMendes, Mônica Bannwart [UNESP]-
Autor(es): dc.creatorMendonça, Bruna Cavecci [UNESP]-
Autor(es): dc.creatorBatista, José Nixon-
Autor(es): dc.creatorTrevisol, Daisson José-
Autor(es): dc.creatorBoyer, Leslie-
Autor(es): dc.creatorChippaux, Jean-Philippe-
Autor(es): dc.creatorMedolago, Natália Bronzatto [UNESP]-
Autor(es): dc.creatorCassaro, Claudia Vilalva [UNESP]-
Autor(es): dc.creatorCarneiro, Márcia Tonin Rigotto [UNESP]-
Autor(es): dc.creatorde Oliveira, Ana Paola Piloto [UNESP]-
Autor(es): dc.creatorPimenta, Daniel Carvalho [UNESP]-
Autor(es): dc.creatorda Cunha, Luís Eduardo Ribeiro-
Autor(es): dc.creatorSantos, Lucilene Delazari dos [UNESP]-
Autor(es): dc.creatorBarraviera, Benedito [UNESP]-
Data de aceite: dc.date.accessioned2022-02-22T00:50:40Z-
Data de disponibilização: dc.date.available2022-02-22T00:50:40Z-
Data de envio: dc.date.issued2021-06-25-
Data de envio: dc.date.issued2021-06-25-
Data de envio: dc.date.issued2021-03-23-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.3389/fimmu.2021.653151-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/207580-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/207580-
Descrição: dc.descriptionWe 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].-
Descrição: dc.descriptionDepartment of Infectology Dermatology Imaging Diagnosis and Radiotherapy Botucatu Medical School (FMB) São Paulo State University UNESP – Univ Estadual Paulista)-
Descrição: dc.descriptionGraduate Program in Tropical Diseases Botucatu Medical School (FMB) São Paulo State University UNESP—Univ Estadual Paulista)-
Descrição: dc.descriptionCenter for the Study of Venoms and Venomous Animals (CEVAP) São Paulo State University (UNESP—Univ Estadual Paulista)-
Descrição: dc.descriptionGraduate Program in Clinical Research Center for the Study of Venoms and Venomous Animals (CEVAP) and Botucatu Medical School (FMB) São Paulo State University (UNESP—Univ Estadual Paulista)-
Descrição: dc.descriptionClinical Research Center Nossa Senhora da Conceição Hospital-
Descrição: dc.descriptionGraduate Program in Health Sciences University of Southern Santa Catarina at Tubarão-
Descrição: dc.descriptionVIPER Institute University of Arizona College of Medicine-
Descrição: dc.descriptionMERIT IRD Université Paris 5-
Descrição: dc.descriptionCRT Institut Pasteur-
Descrição: dc.descriptionClinical Research Unit (UPECLIN) Botucatu Medical School São Paulo State University UNESP—Univ Estadual Paulista)-
Descrição: dc.descriptionBiochemistry and Biophysics Laboratory Butantan Institute-
Descrição: dc.descriptionAntivenom Production Laboratory Vital Brazil Institute-
Descrição: dc.descriptionDepartment of Infectology Dermatology Imaging Diagnosis and Radiotherapy Botucatu Medical School (FMB) São Paulo State University UNESP – Univ Estadual Paulista)-
Descrição: dc.descriptionGraduate Program in Tropical Diseases Botucatu Medical School (FMB) São Paulo State University UNESP—Univ Estadual Paulista)-
Descrição: dc.descriptionCenter for the Study of Venoms and Venomous Animals (CEVAP) São Paulo State University (UNESP—Univ Estadual Paulista)-
Descrição: dc.descriptionGraduate Program in Clinical Research Center for the Study of Venoms and Venomous Animals (CEVAP) and Botucatu Medical School (FMB) São Paulo State University (UNESP—Univ Estadual Paulista)-
Descrição: dc.descriptionClinical Research Unit (UPECLIN) Botucatu Medical School São Paulo State University UNESP—Univ Estadual Paulista)-
Idioma: dc.languageen-
Relação: dc.relationFrontiers in Immunology-
???dc.source???: dc.sourceScopus-
Palavras-chave: dc.subjectantivenom-
Palavras-chave: dc.subjectApis mellifera (Africanized)-
Palavras-chave: dc.subjectclinical trial-
Palavras-chave: dc.subjectenzyme-linked immunosorbent assay (ELISA)-
Palavras-chave: dc.subjectsafety assessment-
Título: dc.titleSingle-Arm, Multicenter Phase I/II Clinical Trial for the Treatment of Envenomings by Massive Africanized Honey Bee Stings Using the Unique Apilic Antivenom-
Tipo de arquivo: dc.typelivro digital-
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