International Centre for Diarrhoeal Disease Research Bangladesh(icddr,b), Dhaka, Bangladesh; Menzies Health Institute Queensland, Gold Coast, Australia.
MSD-Wellcome trust Hilleman Laboratories, India.
Vaccine. 2021 Jul 22;39(32):4450-4457. doi: 10.1016/j.vaccine.2021.06.069. Epub 2021 Jul 1.
The World Health Organization (WHO) recommends the use of oral cholera vaccines (OCVs) as part of an integrated control program, both in highly endemic settings and during cholera epidemics. The available and internationally recommended WHO-prequalified OCVs (Dukoral, Shanchol, Euvichol) contain multiple heat and formalin-killed V. cholerae strains of Inaba and Ogawa serotypes. MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. in technical collaboration with University of Gothenburg, Sweden has developed a new single strain OCV, Hillchol. This vaccine consists of formaldehyde-inactivated whole cell El Tor V. cholerae O1 bacteria engineered into the Hikojima serotype for stable expression of both the Ogawa (AB) and Inaba (AC) LPS antigens on the bacterial surface. We evaluated the safety and immunogenicity of this novel and potentially much less expensive OCV in comparison with Shanchol.
We conducted a randomized, non-inferiority, age-descending clinical trial of OCV (Hillchol vs. Shanchol) in the Mirpur area of Dhaka city from July 2016 to May 2017. This study was carried out in three different age cohorts (1-<5, 5-17 and ≥18 years old). Two doses of vaccine were given at 14 days intervals to 560 healthy participants.
No serious adverse events were reported. There were no significant differences in the rates of adverse events between the test vaccine (Hillchol) and the comparator (Shanchol) group. Serum vibriocidal antibody responses in all age groups combined were comparable for all the O1 Ogawa (59% vs. 67%; 90% CI of difference: -14.55, -0.84) and Inaba (70% vs. 71%; 90% CI of difference: -7.24, 5.77) serotypes, showing that the Hillchol vaccine was non-inferior to Shanchol. This new vaccine was also non-inferior to Shanchol in the different age strata.
The safety and immunogenicity profile of the new OCV Hillchol is comparable to Shanchol in persons residing in a cholera-endemic setting. ClinicalTrials.gov number: NCT02823899.
世界卫生组织（WHO）建议在高度流行地区和霍乱流行期间，将口服霍乱疫苗（OCV）作为综合控制计划的一部分使用。现有的、国际推荐的 WHO 资格预审 OCV（Dukoral、Shanchol、Euvichol）含有多种经热处理和福尔马林灭活的霍乱弧菌 Inaba 和 Ogawa 血清型菌株。瑞典哥德堡大学与 MSD 惠康信托基金会 Hilleman 实验室私人有限公司合作开发了一种新的单一菌株 OCV，Hillchol。该疫苗由福尔马林灭活的全细胞 El Tor 霍乱弧菌 O1 细菌组成，该细菌被工程改造为 Hikojima 血清型，以在细菌表面稳定表达 Ogawa（AB）和 Inaba（AC）LPS 抗原。我们评估了这种新型、潜在价格便宜得多的 OCV 与 Shanchol 相比的安全性和免疫原性。
我们于 2016 年 7 月至 2017 年 5 月在达卡市米尔普尔地区进行了一项 OCV（Hillchol 与 Shanchol）的随机、非劣效性、年龄下降临床试验。这项研究在三个不同的年龄组（1-<5 岁、5-17 岁和≥18 岁）进行。560 名健康参与者在 14 天间隔内接受两剂疫苗。
未报告严重不良事件。试验疫苗（Hillchol）与对照疫苗（Shanchol）组的不良事件发生率无显著差异。所有年龄组的血清杀菌抗体反应在所有 O1 Ogawa（59%对 67%；差异 90%置信区间：-14.55，-0.84）和 Inaba（70%对 71%；差异 90%置信区间：-7.24，5.77）血清型方面相当，表明 Hillchol 疫苗与 Shanchol 疫苗相当。在不同的年龄组中，这种新疫苗也与 Shanchol 疫苗相当。
新的 OCV Hillchol 在居住在霍乱流行地区的人群中的安全性和免疫原性与 Shanchol 相当。ClinicalTrials.gov 编号：NCT02823899。
