Single-Arm, Multicenter Phase I/II Clinical Trial for the Treatment of Envenomings by Massive Africanized Honey Bee Stings Using the Unique Apilic Antivenom

We evaluated the safety, optimal dose, and preliminary effectiveness of a new-approach Africanized honeybee ( Apis mellifera ) Antivenom (AAV) in phase I/II, multicenter, non-randomized, single-arm clinical trial involving 20 participants with multiple stings. Participants received 2 to 10 vials AAV depending on number stings they suffered, or predefined adjuvant, symptomatic, complementary treatment. The primary safety endpoint was occurrence early adverse reactions within first 24 h Preliminary efficacy based evolution, including laboratory findings, assessed at baseline various time points over four following weeks. ELISA assays mass spectrometry were used estimate venom pharmacokinetics before, during, after Twenty adult participants, i.e., 13 (65%) men 7 (35%) women, median age 44 years mean body surface area 1.92 m (median = 1.93 recruited. ranged from > 2,000, 52.5. Symptoms envenoming classified as mild, moderate, severe 80% (16), 15% (3), 5% (1) patients, respectively; patients 2, 6, per protocol. None had late (serum sickness) 30 d There no discontinuation protocol due events, there serious events. One patient moderate event, transient itchy skin, erythroderma. All completed intravenous antivenom infusion h, loss follow-up discharge. showed (melittin PLA concentrations varying between 0.25 1.479 ng/mL prior Venom levels decreased all during hospitalization period. Surprisingly, nine cases (45%), despite recovery absence symptoms, increased again outpatient care Mass melittin eight Considering promising results for this investigational product treatment massive attack, its efficacy, reflected improvements corresponding immediate decrease blood levels, has shown be safe human use. Clinical Trial Registration: UTN: U1111-1160-7011, identifier [RBR-3fthf8].