{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["12"],"submitter":["Barbosa AN"],"pubmed_abstract":["We evaluated the safety, optimal dose, and preliminary effectiveness of a new-approach Africanized honeybee (<i>Apis mellifera</i>) 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, an"],"journal":["Frontiers in immunology"],"pagination":["653151"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8025786"],"repository":["biostudies-literature"],"pubmed_title":["Single-Arm, Multicenter Phase I/II Clinical Trial for the Treatment of Envenomings by Massive Africanized Honey Bee Stings Using the Unique Apilic Antivenom."],"pmcid":["PMC8025786"],"pubmed_authors":["Barraviera B","Cassaro CV","Chippaux JP","Pimenta DC","Barbosa AN","Schuelter-Trevisol F","Trevisol DJ","Medolago NB","da Cunha LER","Ferreira RS","Batista JN","Boyer L","de Carvalho FCT","Dos Santos LD","Mendes MB","Carneiro MTR","Mendonca BC","de Oliveira APP"],"additional_accession":[]},"is_claimable":false,"name":"Single-Arm, Multicenter Phase I/II Clinical Trial for the Treatment of Envenomings by Massive Africanized Honey Bee Stings Using the Unique Apilic Antivenom.","description":"We evaluated the safety, optimal dose, and preliminary effectiveness of a new-approach Africanized honeybee (<i>Apis mellifera</i>) 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, an","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021","modification":"2025-05-29T20:02:01.053Z","creation":"2025-05-29T20:02:01.053Z"},"accession":"S-EPMC8025786","cross_references":{"pubmed":["33841437"],"doi":["10.3389/fimmu.2021.653151"]}}