development and efficacy of the leish-f3+gla-se vaccine for visceral leishmaniasis

This study aimed to evaluate the safety, immunogenicity, and efficacy of the leish-f3+gla-se vaccine in preventing visceral leishmaniasis caused by leishmania donovani and leishmania infantum. the leish-f3+gla-se vaccine, which comprises the leish-f3 antigen and the gla-se adjuvant, was evaluated through preclinical and phase 1 clinical trials. the preclinical studies were conducted using hamster models, whereas the phase 1 trial involved healthy adult volunteers. immunogenicity was assessed by measuring antigen-specific cytokine production and antibody responses. in preclinical studies, the vaccine significantly reduced parasite burdens in hamster models, indicating strong protective efficacy. in the phase 1 clinical trial, the vaccine was found to be safe and well-tolerated, eliciting robust antigen-specific immune responses. participants exhibited increased levels of ifn-γ, tnf, and il-2, which are indicative of a potent th1-type immune response. additionally, low levels of il-5 and il-10 were observed, suggesting a balanced immune profile with minimal th2-type skewing. the leish-f3+gla-se vaccine has demonstrated promising results in both preclinical and clinical settings, showing potential as an effective intervention for the prevention of visceral leishmaniasis. further clinical trials in endemic regions are warranted to confirm its efficacy in immune response.