Safety and immunogenicity of the anti-cocaine vaccine UFMG-VAC-V4N2 in a non-human primate model

• Published in: Vaccine Vol. 41; no. 13; pp. 2127 - 2136
• Main Authors: Sabato, Brian, Augusto, Paulo Sérgio de Almeida, Lima Gonçalves Pereira, Raissa, Coutinho Batista Esteves, Felipe, Caligiorne, Sordaini M., Rodrigues Dias Assis, Bruna, Apolo Correia Marcelino, Sóstenes, Pires do Espírito Santo, Larissa, Dias dos Reis, Karine, Da Silva Neto, Leonardo, Goulart, Gisele, de Fátima, Ângelo, Pierezan, Felipe, Toshio Fujiwara, Ricardo, Castro, Maila, Garcia, Frederico
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 24-03-2023; Elsevier Limited
• Subjects: Addictions; Aluminum; Animals; Anti-drug vaccine; Antibodies; Anticocaine vaccine; Blood-brain barrier; Brain research; Calixarenes; Cholera; Clinical trials; Cocaine; Cocaine - adverse effects; Cocaine use disorder; Cocaine-Related Disorders - therapy; Drug abuse; Drug dosages; FDA approval; Feeding behavior; Immune response; Immune system; Immunogenicity; Immunogenicity, Vaccine; International regulations; Laboratory animals; Medical research; Molecular weight; Monkeys & apes; Narcotics; NMR; Nuclear magnetic resonance; Polyethylene glycol; Preclinical study; Primates; Proteins; Safety; Safety study; Toxicity; Vaccines; United States > US; Safety study; Preclinical study; Cocaine use disorder; Anti-drug vaccine; Anticocaine vaccine
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2023.02.031

A promising strategy for cocaine addiction treatment is the anti-drug vaccine. These vaccines induce the production of anticocaine antibodies, capable of linking to cocaine, and decrease the passage of cocaine throughout the blood–brain barrier, decreasing drug activity in the brain. Our research group developed a new vaccine candidate, the UFMG-V4N2, to treat cocaine use disorders (CUD) using an innovative carrier based on calixarenes. This study assessed the safety and immunogenicity of the anti-cocaine vaccine UFMG-VAC-V4N2 in a non-human primate toxicity study using single and multiple vaccine doses. The UFMG-VAC-V4N2 yielded only mild effects in the injection site and did not influence the general health, feeding behavior, or hematological, renal, hepatic, or metabolic parameters in the vaccinated marmosets. The anti-cocaine vaccine UFMG-VAC-V4N2 presented a favorable safety profile and induced the expected immune response in a non-human primate model of Callithrix penicillata. This preclinical UFMG-VAC-V4N2 study responds to the criteria required by international regulatory agencies contributing to future anticocaine clinical trials of this anti-cocaine vaccine.