Open AccessSafety and Immunogenicity of a Recombinant Tetanus Vaccine in Healthy Adults in China: A Randomized, Double‐Blind, Dose Escalation, Placebo‐ and Positive‐Controlled, Phase 1/2 Trial
Author(s) -
Xu Xiaowei,
Yu Rui,
Xiao Lanlan,
Wang Jie,
Yu Meihong,
Xu Junjie,
Tan Yajun,
Ma Xiao,
Wu Xiaoxin,
Lian Jiangshan,
Huang Kaizhou,
Ouyang Xiaoxi,
Bi Sheng,
Wu Shipo,
Wang Xiaoyan,
Jin Jiandi,
Yu Ling,
Zhang Huafen,
Wei Qi,
Shi Jinfa,
Chen Wei,
Li Lanjuan
Publication year - 2021
Publication title -
advanced science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.388
H-Index - 100
ISSN - 2198-3844
DOI - 10.1002/advs.202002751
Subject(s) - tetanus , medicine , toxoid , immunogenicity , vaccination , adverse effect , placebo , immunology , virology , immune system , alternative medicine , pathology
Tetanus is a fatal but vaccine‐preventable disease. The currently available tetanus vaccines are tetanus toxoid (TT)‐based. Although these vaccines are generally effective, challenges in vaccine development and access remain. A randomized, double‐blind, dose escalation, placebo‐ and positive‐controlled, 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‐Hc) 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 enrolled and randomly assigned to receive one of the three doses of recombinant tetanus vaccine (TeNT‐Hc 10/20/30 µg), 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‐related adverse events occur. The recombinant tetanus vaccine shows strong immune responses (seroconversion rates, geometric mean titer, and antigen‐specific CD4+/CD8+ T‐cell 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.