The Salmonella Vaccine Study in Oxford is a randomised placebo-controlled participant-observer blind phase I study of the iNTS-GMMA vaccine. Healthy adult volunteers will be randomised to receive three intramuscular injections of the iNTS-GMMA vaccine, containing equal quantities of S. Typhimurium and S. Enteritidis GMMA particles adsorbed on Alhydrogel, or an Alhydrogel placebo at 0, 2 and 6 months. Participants will be sequentially enrolled into three groups: group 1, 1:1 randomisation to low dose iNTS-GMMA vaccine or placebo; group 2, 1:1 randomisation to full dose iNTS-GMMA vaccine or placebo; group 3, 2:1 randomisation to full dose or lower dose (dependant on DSMC reviews of groups 1 and 2) iNTS-GMMA vaccine or placebo.The primary objective is safety and tolerability of the vaccine. The secondary objective is immunogenicity as measured by O-antigen based ELISA. Further exploratory objectives will characterise the expanded human immune profile.
Ethical approval for this study has been obtained from the South Central-Oxford A Research Ethics Committee (Ethics REF:22/SC/0059). Appropriate documentation and regulatory approvals have been acquired. Results will be disseminated via peer-reviewed articles and conferences.
EudraCT Number: 2020-000510-14.
方法:牛津的沙门氏菌疫苗研究是一项关于iNTS-GMMA疫苗的随机安慰剂对照参与者-观察者盲I期研究。健康的成年志愿者将随机接受三次肌内注射iNTS-GMMA疫苗,含有等量的吸附在Alhydrogel上的鼠伤寒沙门氏菌和肠炎沙门氏菌GMMA颗粒,或在0、2和6个月服用Alhydrogel安慰剂。参与者将依次分为三组:第1组,1:1随机分配给低剂量iNTS-GMMA疫苗或安慰剂;第2组,1:1随机分配给全剂量iNTS-GMMA疫苗或安慰剂;第3组,2:1随机分配给全剂量或低剂量(取决于第1组和第2组的DSMC评论)iNTS-GMMA疫苗或安慰剂。主要目标是疫苗的安全性和耐受性。第二个目的是通过基于O-抗原的ELISA测量的免疫原性。进一步的探索目标将表征扩大的人类免疫谱。
背景:这项研究的伦理批准已从牛津中南部A研究伦理委员会获得(伦理学REF:22/SC/0059)。已获得适当的文件和监管批准。结果将通过同行评审的文章和会议传播。
背景:EudraCT编号:2020-000510-14。