{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T07:04:14Z","timestamp":1782457454192,"version":"3.54.5"},"reference-count":35,"publisher":"Wiley","issue":"15","license":[{"start":{"date-parts":[[2021,6,3]],"date-time":"2021-06-03T00:00:00Z","timestamp":1622678400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["advanced.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Advanced Science"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tetanus is a fatal but vaccine\u2010preventable disease. The currently available tetanus vaccines are tetanus toxoid (TT)\u2010based. Although these vaccines are generally effective, challenges in vaccine development and access remain. A randomized, double\u2010blind, dose escalation, placebo\u2010 and positive\u2010controlled, phase 1\/2 trial (ChiCTR1800015865) is performed to evaluate the safety and immunogenicity of an alternative recombinant tetanus vaccine based on the Hc domain of tetanus neurotoxin (TeNT\u2010Hc) in healthy adult volunteers. The primary outcome is the safety profile of the recombinant tetanus vaccine, and immunogenicity is the secondary outcome. 150 eligible participants were\u00a0enrolled and randomly assigned to receive one of the three doses of recombinant tetanus vaccine (TeNT\u2010Hc 10\/20\/30\u00a0\u00b5g), TT vaccine, or placebo. The recombinant tetanus vaccine shows a good safety profile. The frequency of any solicited and unsolicited adverse events after each vaccination does not differ across the vaccine and placebo recipients. No serious treatment\u2010related adverse events occur. The recombinant tetanus vaccine shows strong immune responses (seroconversion rates, geometric mean titer, and antigen\u2010specific CD4+\/CD8+ T\u2010cell responses), which are roughly comparable to those of the TT vaccine. In conclusion, the findings from this study support that recombinant tetanus vaccine is safe and immunogenic; thereby, it represents a novel vaccine candidate against tetanus.<\/jats:p>","DOI":"10.1002\/advs.202002751","type":"journal-article","created":{"date-parts":[[2021,6,4]],"date-time":"2021-06-04T07:04:14Z","timestamp":1622790254000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Safety and Immunogenicity of a Recombinant Tetanus Vaccine in Healthy Adults in China: A Randomized, Double\u2010Blind, Dose Escalation, Placebo\u2010 and Positive\u2010Controlled, Phase 1\/2 Trial"],"prefix":"10.1002","volume":"8","author":[{"given":"Xiaowei","family":"Xu","sequence":"first","affiliation":[{"name":"State Key Laboratory for Diagnosis and Treatment of Infectious Diseases National Clinical Research Centre for Infectious Diseases Collaborative Innovation Centre for Diagnosis and Treatment of Infectious Diseases First 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