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The efficacy limitations and safety concerns of the existing killed whole cell and live\u2010attenuated vaccines call for the development of new vaccines. In this study, we evaluated the immunogenicity and safety of a novel subunit plague vaccine, comprising native F1 antigen and recombinant V antigen. The cynomolgus macaques in low\u2010 and high\u2010dose vaccine groups were vaccinated at weeks 0, 2, 4 and 6, at dose levels of 15 \u03bcg F1 + 15 \u03bcg rV and 30 \u03bcg F1 + 30 \u03bcg rV respectively. Specific antibodies and interferon\u2010\u03b3 and interleukin\u20102 expression in lymphocytes were measured. For safety, except for the general toxicity and local irritation, we made a systematic immunotoxicity study on the vaccine including immunostimulation, autoimmunity and anaphylactic reaction. The vaccine induced high levels of serum anti\u2010F1 and anti\u2010rV antibodies, and caused small increases of interferon\u2010\u03b3 and interleukin\u20102 in monkeys. The vaccination led to a reversible increase in the number of peripheral blood eosinophils, the increases in serum IgE level in a few animals and histopathological change of granulomas at injection sites. The vaccine had no impact on general conditions, most clinical pathology parameters, percentages of T\u2010cell subsets, organ weights and gross pathology of treated monkeys and had passable local tolerance. The F1 + rV subunit plague vaccine can induce very strong humoral immunity and low level of cellular immunity in cynomolgus macaques and has a good safety profile.<\/jats:p>","DOI":"10.1002\/jat.3550","type":"journal-article","created":{"date-parts":[[2017,11,14]],"date-time":"2017-11-14T01:22:41Z","timestamp":1510622561000},"page":"408-417","source":"Crossref","is-referenced-by-count":9,"title":["A safety and immunogenicity study of a novel subunit plague vaccine in cynomolgus macaques"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9801-128X","authenticated-orcid":false,"given":"Li","family":"Liu","sequence":"first","affiliation":[{"name":"National Center for Safety Evaluation of Drugs National Institutes for Food and Drug Control  A8 Hong Da Middle Street, Yizhuang Economic Development Area Beijing 100176 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dong","family":"Wei","sequence":"additional","affiliation":[{"name":"Institute for the Control of Biological Products National Institutes for Food and Drug Control  31 Huatuo Road, Daxing District Beijing 102269 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhe","family":"Qu","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs National Institutes for Food and Drug Control  A8 Hong Da Middle Street, Yizhuang Economic Development Area Beijing 100176 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Sun","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs National Institutes for Food and Drug Control  A8 Hong Da Middle Street, Yizhuang Economic Development Area Beijing 100176 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yufa","family":"Miao","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs National Institutes for Food and Drug Control  A8 Hong Da Middle Street, Yizhuang Economic Development Area Beijing 100176 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanwei","family":"Yang","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs National Institutes for Food and Drug Control  A8 Hong Da Middle Street, Yizhuang Economic Development Area Beijing 100176 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinbiao","family":"Lu","sequence":"additional","affiliation":[{"name":"Institute for the Control of Biological Products National Institutes for Food and Drug Control  31 Huatuo Road, Daxing District Beijing 102269 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weixin","family":"Du","sequence":"additional","affiliation":[{"name":"Institute for the Control of Biological Products National Institutes for Food and Drug Control  31 Huatuo Road, Daxing District Beijing 102269 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bingxiang","family":"Wang","sequence":"additional","affiliation":[{"name":"Lanzhou Institute of Biological Products Co.  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