1 Lab. of Vaccinol. & Appl. Immunol., Sch. of Pharm., Kanazawa Univ.2 Inst. Leônidas & Maria Deane, Fiocruz, Manaus, Brazil.3 Div. of Genetic Ther., Ctr. for Mol. Med., Jichi Med. Univ.4 Res. Inst. of Pharm. Sci., Musashino Univ.5 Lab. of Primate Model, Res. Ctr. for Infect. Dis., Inst. for Life & Med. Sci., Kyoto Univ.A Viral-Vectored Vaccine Targeting Multiple Stages of Plasmodium vivax We have developed an innovative and effective malaria vaccine platform, which consists of a highly attenuated vaccinia strain (LC16m8Δ) and adeno-associated virus type 1 (AAV1) expressing a P.vivax Pvs25-PvCSP fusion protein. The vaccine, m8∆/AAV1-Pv(s25-CSP), is designed to integrate with the WHO Expanded Program on Immunization (EPI) for infants.A heterologous m8Δ-prime/AAV1-boost regimen has demonstrated high efficacy in both protection and transmission blocking in a murine model, with notably longer-lasting immunity compared to other malaria vaccines.This study evaluated the safety and efficacy of m8∆/AAV1-Pv(s25-CSP) in a non-human primate model. Three rhesus monkeys were immunized with the m8Δ-prime/AAV1-boost regimen as the murine model, resulting in the robust induction of PvCSP-and Pvs25-specific IgG antibodies. Remarkably, vaccine-induced immune responses persisted for over six months and provided in vitro sporozoite neutralization against transgenic PvCSP/Pb sporozoites and transmission-blocking efficacy against P.vivax in the Brazil strain. These findings confirm that our vaccine has extensive high-quality preclinical data, a robust antibody response, and substantial efficacy against malaria’s pre-erythrocytic and sexual stages in non-human primates.Preclinical Immunogenicity and Efficacy 〇Yutaro Yamamoto1 Camila Fabbri2 Manaka Ono1 Yuma Asaki1Ryota Watano3 Mitsuhiro Iyori4 Ammar Abdurrahman Hasyim1 Hiroaki Mizukami3 Hisatoshi Shida5 Hiromi Sakawaki5 Tomoyuki Miura5 Stefanie Lopes2 Shigeto Yoshida131P 001
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