A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom

Alexandre Naime Barbosa, Leslie Boyer, Jean Philippe Chippaux, Natalia Bronzatto Medolago, Carlos Antonio Caramori, Ariane Gomes Paixão, João Paulo Vasconcelos Poli, Mônica Bannwart Mendes, Lucilene Delazari dos Santos, Rui Seabra Ferreira, Benedito Barraviera

Research output: Research - peer-reviewArticle

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Abstract

Background: Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality of 0.25%). The toxins present in the venom, which include melittin and phospholipase A2, cause lesions in diverse organs and systems that may be fatal. As there has been no specific treatment to date, management has been symptomatic and supportive only. Methods: In order to evaluate the safety and neutralizing capacity of a new apilic antivenom, as well as to confirm its lowest effective dose, a clinical protocol was developed to be applied in a multicenter, non-randomized and open phase I/II clinical trial. Twenty participants with more than five stings, aged more than 18 years, of both sexes, who have not previously received the heterologous serum against bee stings, will be included for 24 months. The proposed dose was based on the antivenom neutralizing capacity and the number of stings. Treatment will be administered only in a hospital environment and the participants will be evaluated for a period up to 30 days after discharge for clinical and laboratory follow-up. Results: This protocol, approved by the Brazilian regulatory agencies for ethics (National Commission for Ethics on Research - CONEP) and sanitation (National Health Surveillance Agency - ANVISA), is a guideline constituted by specific, adjuvant, symptomatic and complementary treatments, in addition to basic orientations for conducting a clinical trial involving heterologous sera. Conclusions: This is the first clinical trial protocol designed specifically to evaluate the preliminary efficacy and safety of a new antivenom against stings from the Africanized honeybee Apis mellifera. The results will support future studies to confirm a new treatment for massive bee attack that has a large impact on public health in the Americas.

LanguageEnglish (US)
Article number14
JournalJournal of Venomous Animals and Toxins Including Tropical Diseases
Volume23
Issue number1
DOIs
StatePublished - Mar 16 2017

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antivenoms
Apis mellifera
honey bees
clinical trials
Antivenins
Bees
Bites and Stings
Clinical Protocols
Clinical Trials
Therapeutics
ethics
neutralization
Apoidea
public health
dosage
Public health
Health
Public Health
Safety
Serum

Keywords

  • Apilic antivenom
  • Apis mellifera
  • Bee antivenom
  • Bee venom
  • Envenomation
  • Heterologous serum
  • Toxins

ASJC Scopus subject areas

  • Parasitology
  • Animal Science and Zoology
  • Toxicology
  • Infectious Diseases

Cite this

A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom. / Barbosa, Alexandre Naime; Boyer, Leslie; Chippaux, Jean Philippe; Medolago, Natalia Bronzatto; Caramori, Carlos Antonio; Paixão, Ariane Gomes; Poli, João Paulo Vasconcelos; Mendes, Mônica Bannwart; dos Santos, Lucilene Delazari; Ferreira, Rui Seabra; Barraviera, Benedito.

In: Journal of Venomous Animals and Toxins Including Tropical Diseases, Vol. 23, No. 1, 14, 16.03.2017.

Research output: Research - peer-reviewArticle

Barbosa, AN, Boyer, L, Chippaux, JP, Medolago, NB, Caramori, CA, Paixão, AG, Poli, JPV, Mendes, MB, dos Santos, LD, Ferreira, RS & Barraviera, B 2017, 'A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom' Journal of Venomous Animals and Toxins Including Tropical Diseases, vol 23, no. 1, 14. DOI: 10.1186/s40409-017-0106-y
Barbosa, Alexandre Naime ; Boyer, Leslie ; Chippaux, Jean Philippe ; Medolago, Natalia Bronzatto ; Caramori, Carlos Antonio ; Paixão, Ariane Gomes ; Poli, João Paulo Vasconcelos ; Mendes, Mônica Bannwart ; dos Santos, Lucilene Delazari ; Ferreira, Rui Seabra ; Barraviera, Benedito. / A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom. In: Journal of Venomous Animals and Toxins Including Tropical Diseases. 2017 ; Vol. 23, No. 1.
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