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<p>Enterovirus (EV) A71 causes endemic outbreaks of hand-foot-mouth disease (HFMD) and herpangina in young children, occasionally leading to severe complications and fatal outcomes. We evaluated EnVAX-A71, a bioreactor-produced, aluminum-adjuvanted inactivated EV-A71 (B4/E59) vaccine, in a randomized, double-blind, placebo-controlled phase 3 trial in Taiwan and Vietnam. A total of 4011 children aged 2–71 months were randomized 3:2 to vaccine or placebo; the primary endpoint was laboratory-confirmed EV-A71-associated HFMD/herpangina, evaluated from 28 days after dose two over a follow-up of 1 to 2 years (median, 490 days). In the primary analysis (<i>n</i> = 3733), one case occurred in vaccine recipients versus 70 in placebo (0.3 vs 39.2 per 1000 person-years), yielding 99.2% vaccine efficacy (95% CI: 94.3–99.9, <i>p</i> &lt; 0.001). Seroprotection (neutralizing antibody titer ≥1:32) reached 98.7% at day 56 and remained ≥98% through one year. No vaccine-group hospitalizations occurred versus 19 in placebo (100% efficacy, 95% CI: 90.6–100.0). Safety profiles were comparable between groups. These findings support EnVAX-A71 for endemic EV-A71 control (ClinicalTrials.gov NCT05099029).</p>

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A randomised trial of a bioreactor-produced EV-A71 vaccine for endemic control in children

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月12日

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  • Kao-Pin Hwang,
  • Quang Chan Luong,
  • Yhu-Chering Huang,
  • Chou-Cheng Lai,
  • Phuc Hong Le,
  • Mai Tuyet Thi Tran,
  • Boon-Fatt Tan,
  • Po-Yen Chen,
  • Shun-Cheng Yang,
  • Wei-Ting Liu,
  • Nguyen Thi Thanh Thao,
  • Pochun Lee,
  • Shu-Ting Lin,
  • Chung-Cheng Liu,
  • Chwen-Cheng Chen,
  • Chin-Fen Yang,
  • Li-Min Huang

摘要

Enterovirus (EV) A71 causes endemic outbreaks of hand-foot-mouth disease (HFMD) and herpangina in young children, occasionally leading to severe complications and fatal outcomes. We evaluated EnVAX-A71, a bioreactor-produced, aluminum-adjuvanted inactivated EV-A71 (B4/E59) vaccine, in a randomized, double-blind, placebo-controlled phase 3 trial in Taiwan and Vietnam. A total of 4011 children aged 2–71 months were randomized 3:2 to vaccine or placebo; the primary endpoint was laboratory-confirmed EV-A71-associated HFMD/herpangina, evaluated from 28 days after dose two over a follow-up of 1 to 2 years (median, 490 days). In the primary analysis (n = 3733), one case occurred in vaccine recipients versus 70 in placebo (0.3 vs 39.2 per 1000 person-years), yielding 99.2% vaccine efficacy (95% CI: 94.3–99.9, p < 0.001). Seroprotection (neutralizing antibody titer ≥1:32) reached 98.7% at day 56 and remained ≥98% through one year. No vaccine-group hospitalizations occurred versus 19 in placebo (100% efficacy, 95% CI: 90.6–100.0). Safety profiles were comparable between groups. These findings support EnVAX-A71 for endemic EV-A71 control (ClinicalTrials.gov NCT05099029).