The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, 6 months, or 11 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks, 6 months, or 11 months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks, 6 months, or 11 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks, 6 months, or 11 months following the first dose of vaccine. The hypothesis is that the vibriocidal GMT following the second dose, when given after 6 or 12 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.

开始日期2018-10-23

申办/合作机构

Johns Hopkins Bloomberg School of Public Health

[+1]

NCT03373669

/ Completed临床4期IIT

Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine

Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5 years in an endemic setting.
The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, or 6 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks or 6 months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (anti-LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine. Our hypothesis is that the vibriocidal GMT following the second dose, when given after 6 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.

开始日期2017-11-16

申办/合作机构

Johns Hopkins Bloomberg School of Public Health

100 项与 Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc) 相关的临床结果

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项与 Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc) 相关的文献（医药）

2025-05-01·VACCINE

A double-blind, randomised phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot to lot consistency of single component oral cholera vaccine BBV131 (Hillchol®) in comparison to Shanchol™

Article

作者: Chavan, Abhishek ; Patnaik, Badri ; Reddy, Siddharth ; Reddy, Bhargav ; Redkar, Sagar ; Suma Priya, M ; Singh, Chandramani ; Vadrevu, Krishna Mohan ; Ganneru, Brunda ; Khalatkar, Vasant ; Prasad, Sai D ; Yandapally, Sriharsha ; Ella, Raches ; Chakravarthy, B S ; Verma, Savita ; Holmgren, Jan ; Tripathi, Vishal ; Chawla, Amit

BACKGROUND:

Cholera is a vaccine-preventable disease that has faced a surge in outbreaks and a shortage of vaccines. The new generation oral cholera vaccine (OCV) BBV131, featuring a simplified single stable O1 Hikojima strain, aims to enhance production efficiency and affordability. This study evaluates BBV131's immune profile, safety, and non-inferiority compared to Shanchol™ in healthy adults and children. Adding BBV131 to the vaccine stockpile could improve supply, simplify logistics, and ease administration efforts.

METHODS:

In this randomised, modified, double-blind, multi-centre, phase III trial, 1800 participants were recruited across 10 clinical trial sites across India. Participants were stratified into three age groups (adults >18 years, children ≥5 to <18 years, and infants ≥1 to <5 years) and were randomised in a 3:1 ratio to receive either BBV131 or Shanchol™. All participants received two doses of the vaccine orally on days 0 and 14. Immunogenicity was assessed through blood samples collected at baseline, two weeks after each dose, and follow-ups at days 28, 56, 90, and 180. The primary endpoint focused on the proportion of participants achieving >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days post two doses. While secondary endpoints included Geometric Mean Titre (GMT) measurements and safety. Safety was evaluated throughout the study, reporting solicited and unsolicited adverse events (AEs). Another cohort of 1800 was added to the above study as an addendum to expand the safety database.

FINDINGS:

Of the 1800 enrolled participants, 1794 completed the study. Post-vaccination, the percentage of participants in the BBV131 group who exhibited a > 4-fold increase in anti-V. cholerae antibody titres were 68.25 % for Ogawa and 69.52 % for Inaba-demonstrating non-inferiority to Shanchol™, with a lower limit of 95 % CI above the non-inferiority margin. The safety profile revealed 257 AEs among 236 participants (13.1 %), with similar incidence across age groups and between vaccines; common AEs included dry mouth and headache.

INTERPRETATION:

The findings indicate that BBV131 demonstrates non-inferior immunogenicity and comparable safety to Shanchol™ in healthy Indian adults and children, supporting its potential as an effective OCV.

CLINICAL TRIAL REGISTRATION:

CTRI/2022/01/039734.

2025-05-01·VACCINE

Effectiveness of rBS/WC cholera vaccine against bacterial infectious diarrhea: A test-negative study on children aged 2–6 years in Guangzhou China

Article

作者: Zhang, Zhoubin ; Zhang, Chunhuan ; Liu, Wenhui ; Long, Qianyi ; He, Qing ; Luo, Lei ; Wang, Hui

BACKGROUND:

Recombinant B-subunit/Whole Cell Cholera Vaccine (rBS/WC) represents a new and effective way to protect against and control diarrhea. A test-negative case-control study was conducted to investigate the cross-protective effect of cholera vaccine immunization against bacterial infectious diarrhea in a real-world setting.

METHODS:

Using a test-negative design, children aged 2-6 years with infectious diarrhea in Guangzhou City were selected as study subjects. A 1:4 propensity score matching based on the basic characteristics of the included study subjects, and vaccine effects were calculated after correcting for confounders.

RESULTS:

A total of 2796 children with laboratory-confirmed infectious diarrhea were enrolled in the study, and 316 pairs were successfully enrolled in the matching after Propensity Score Matching(PSM), totaling 1306. By conditional logistic regression analysis, The results showed that the total protective effect of ≥1 dose of rBS/WC vaccine against bacterial infectious diarrhea in children aged 2-6 years was 57.7 % (95 % CI: 30.3-74.3); the rBS/WC vaccine had the best protective effect of 74.8 % (95 % CI: 16.8-95.6) within 6 months of vaccination and then showed a decreasing trend. The vaccine's protective effect was 54.6 % (95 % CI: 22.1-73.5) against Salmonella and 69.2 % (95 % CI: -133.7-95.9) against Escherichia coli. Stratified analyses revealed higher point estimates of the protective effect obtained by vaccination among healthy children with good hygiene.

CONCLUSIONS:

These findings support the idea that the rBS/WC vaccination program is effective in the real world in preventing bacterial diarrhea in children. For people who are susceptible to bacterial diarrhea, the cholera vaccine is a good preventive option.

2025-03-04·Journal of biomolecular structure & dynamics

Design of a multi-epitope vaccine (vme-VAC/MST-1) against cholera and vibriosis based on reverse vaccinology and immunoinformatics approaches

Article

作者: Santos, Eduardo Horta ; Tiwari, Sandeep ; Soares, Siomar ; Azevedo, Vasco ; Martins, Flaviano S. ; Marques, Pedro Henrique ; Oliveira, Carlo Jose Freire ; Rodrigues, Thais Cristina Vilela ; Aburjaile, Flavia Figueira ; Bleicher, Lucas

Vibriosis and cholera are serious diseases distributed worldwide and caused by six marine bacteria of the Vibrio genus. Thousands of deaths occur each year due to these illnesses, necessitating the development of new preventive measures. Presently, the existing cholera vaccine demonstrates an effectiveness of approximately 60%. Here we describe a new multi-epitope vaccine, 'vme-VAC/MST-1' based on vaccine targets identified by reverse vaccinology and epitopes predicted by immunoinformatics, two currently effective tools for predicting new vaccines for bacterial pathogens. The vaccine was designed to combat vibriosis and cholera by incorporating epitopes predicted for CTL, HTL, and B cells. These epitopes were identified from six vaccine targets revealed through subtractive genomics, combined with reverse vaccinology, and were further filtered using immunoinformatics approaches based on their predicted immunogenicity. To construct the vaccine, 28 epitopes (24 CTL/B and 4 HTL/B) were linked to the sequence of the cholera toxin B subunit adjuvant. In silico analyses indicate that the resulting immunogen is stable, soluble, non-toxic, and non-allergenic. Furthermore, it exhibits no homology to the host and demonstrates a strong capacity to elicit innate, B-cell, and T-cell immune responses. Our analysis suggests that it is likely to elicit immune reactions mediated through the TLR5 pathway, as evidenced by the molecular docking of the vaccine with the receptor, which revealed high affinity and a favorable reaction. Thus, vme-VAC/MST-1 is predicted to be a safe and effective solution against pathogenic Vibrio spp. However, further experimental analyses are required to measure the vaccine's effects In vivo.Communicated by Ramaswamy H. Sarma.

项与 Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc) 相关的新闻（医药）

2023-08-28

·Pharmaceutical Technology

GC Biopharma and Eubiologics enter deal to produce cholera vaccine

The companies will jointly manufacture the cholera vaccine from the first half of 2024. Credit: Andrey_Popov / Shutterstock.com. South Korean biopharmaceutical firm GC Biopharma has signed a memorandum of understanding (MOU) with Eubiologics to jointly manufacture oral cholera vaccine, Euvichol. Under the deal, both companies will collaborate for the vaccine supply. Eubiologics will oversee the bulk manufacturing of the vaccine while GC Biopharma will be responsible for conducting the packaging process including the bottling of vials. The parties will jointly manufacture Euvichol from the first half of 2024 for supply to the United Nations International Children’s Emergency Fund (UNICEF). UNICEF had sought further supply of vaccines apart from those of a plastic-tubed Euvichol-Plus to address the recent spread of cholera infection in various areas such as Africa. Eubiologics and the International Vaccine Institute (IVI) co-developed Euvichol for the prevention of cholera. The vaccine received World Health Organization Prequalification in 2015 and the supply of doses to UNICEF started in 2016. As of 2022, a total of 100 million vaccine doses were supplied to the UN agency. Eubiologics vice-president Kyeong-Ho Min said: “With the more frequent floods and droughts due to climate change and global warming, the world is currently experiencing rapid spread of cholera, leading to a shortage of vaccine supply. “The MOU will be a big boost to the increase of vaccine supply, and it will bring us not only more revenue, but also a way to further contribute to controlling the spread of cholera.”

疫苗

2023-08-25

·PRNewswire

GC Biopharma to Produce Cholera Vaccines Jointly with Eubiologics

YONGIN, South Korea, Aug. 25, 2023 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced today that it has signed a MOU at its headquarters in Yongin, South Korea with Eubiologics for a co-production of Euvichol, an oral cholera vaccine. Under the MOU, both parties agreed to cooperate for a successful supply of the vaccine. While Eubiologics, a developer and producer of Euvichol, takes charge of the bulk vaccine production, GC Biopharma will be in charge of the packaging process including vial bottling. The two companies will produce the vaccine together from the first half of 2024 in order to supply to UNICEF. UNICEF has requested for an additional supply of the vaccine on top of the normal supply of a plastic-tubed Euvichol-Plus to cope with a recent spread of cholera infection in many regions including Africa. Euvichol is an oral vaccine jointly developed by Eubiologics and International Vaccine Institute (IVI) for the prevention of cholera, a disease that is prevalent mainly in the developing countries. The vaccine has obtained WHO Prequalification in 2015, and since starting to supply to UNICEF in 2016, the total cumulative supply of the vaccine as of 2022 has exceeded 100 million doses. Eubiologics in currently supplying 100% of cholera vaccines administered by UNICEF. Kyeong-Ho Min, Vice President of Eubiologics commented, "With the more frequent floods and droughts due to climate change and global warming, the world is currently experiencing rapid spread of cholera, leading to a shortage of vaccine supply." And He added that "the MOU will be a big boost to the increase of vaccine supply, and it will bring us not only more revenue, but also a way to further contribute to controlling the spread of cholera". Woo Jin Lee, Head of Global Business Division of GC Biopharma, stated, "Both companies will extend their utmost efforts for the increase of cholera vaccine supply based on their unique strengths" and added that "we will continue to explore more collaboration with other parties to contribute to the better public health of the world". About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century. This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Sohee Kim [email protected] Yelin Jun [email protected] SOURCE GC Biopharma

疫苗

2022-07-11

·E药经理人

关于武汉大学出现的霍乱病例，官方回应来了！

据湖北省武汉市武昌区卫生健康局7月11日通报，武汉大学出现一例感染性腹泻病例，经省市区三级疾控中心复核，该病例的血清学凝集试验为O139阳性，诊断为霍乱。患者经有效诊治，病情已得到控制，症状已消失。图 | 武昌区卫生健康局通报（来源：大成武昌）武汉大学回应据人民日报7月11日报道，武汉大学对该病例情况及相关问题进行了回复：Q1：武昌区卫生健康局发布消息，确认武汉大学出现一例霍乱病例，具体情况是怎样的？A1：7月9日21:30，武昌区疾控通知武汉大学发现一名疑似霍乱感染病例，学校迅即行动，在省、市、区疾控部门指导下开展处置工作。经核查，该病例为武汉大学研究生，住工学部八舍，有胃肠炎既往病史。7月8日5时左右出现发热、呕吐、腹泻，7月8日10时前往武汉大学医院就诊，因其腹泻3次以上转诊至武汉大学中南医院。目前该生已按相关要求转诊至武汉大学人民医院隔离治疗。据疾控部门反馈，该生新冠病毒核酸检测阴性，湖北省疾控中心和武汉市疾控中心对原样开展复核，血清学凝集试验均为O139阳性，诊断为霍乱，毒力基因阴性（霍乱弧菌致病力较弱），目前经有效诊治，该生情况稳定，症状已消失。截至7月10日19：36，通过对264名重点人群、259个点位进行快检，未检出O1、O139群霍乱弧菌，未发现新增病例。Q2：针对该情况，武汉大学采取了哪些应急措施？A2：7月9日晚，接疾控中心通知后，学校高度重视，学校党政主要领导立即指示党政办公室、校医院、学生工作部门、后勤部门、保卫部门等积极对接，全力配合政府卫健、疾控部门，切实做好学生治疗、环境监测、封控楼栋学生生活保障、心理援助等工作。1.主动对接属地7月9日晚起，在区卫健局、区疾控部门指导下，连夜对工学部八舍、该生所在实验室进行封控。同时，对接武昌区委、区政府成立应急处置工作领导小组，学校成立公共卫生应急处置工作专班，各相关部门积极配合属地，共同做好处置工作。2.迅即做好密接人员检测和环境处置7月9日，确定该生密接3人（同住室友2人、同餐人员1人），已转至学校隔离点集中隔离。7月9日晚至10日凌晨，完成工学部八舍254名学生、3名宿管、15家商户的采样工作，相关区域临时封控，相关人员按要求进行隔离，并服用预防性药物。组织专门力量，全面做好对封控人员的生活保障、心理帮扶等工作。对工学部八舍公共区域、宿舍、卫生间、排污管道，该生所在的实验室楼栋等封控后已开展环境采样和终末消毒。针对该生7月8日在武汉大学医院接触的医护人员、检验人员进行采样，开展霍乱弧菌检测，对相关环境开展检测和终末消毒。排查7月1日-10日以来就诊的19例腹泻病例情况，按要求采样并开展霍乱弧菌检测。针对该生7月5日以来校内就餐、购买食物和饮品的食堂、餐馆、小卖部等6个点位，进行环境采样和终末消杀，相关人员进行服用预防性药物、居家观察等处置。3.全面开启夏季肠道传染病宣教工作武汉大学已开展一系列夏季肠道传染病的健康宣教工作，譬如：将《关于加强夏季肠道传染病预防的温馨提示》发布在学校主页，提高师生个人防护意识；邀请医学专家开展专题宣讲；通过新媒体等多种形式提示师生，做好夏季肠道疾病预防；在全校范围内进一步开展爱国卫生运动等。Q3：目前，武汉大学的情况怎样？A3：霍乱属于消化道传播疾病，在我国一直有零星出现。根据国家疾病预防控制局2022年4月发布的数据，2021年全国甲类传染病霍乱报告发病5例，无死亡病例。现代医学对霍乱有成熟的治疗手段，可防、可控、可治。夏季是肠道传染病的高发季节，武汉大学已采取一系列防范措施，保护师生身体健康。目前，武汉大学各方面秩序良好，工作正常开展。感谢社会公众、广大校友对武汉大学的关心，也请广大师生不要恐慌，注意个人卫生，并做好自我健康监测。关于霍乱根据世界卫生组织官网显示，针对霍乱，有以下几点知识需要了解：1.霍乱是由摄入被霍乱弧菌污染的食物或水引起的急性腹泻感染。2.大多数感染者没有症状或症状轻微，可以通过口服补液成功治疗。3.严重病例需要静脉输液和适当抗生素快速治疗。4.提供安全的水和卫生设施对于预防和控制霍乱和其他水传播疾病的传播至关重要。5.口服霍乱疫苗应与改善水和卫生设施一起使用，以控制霍乱暴发，并在已知的霍乱高风险地区进行预防。6.研究人员估计，全世界每年有1.3到400万例霍乱病例，全球有2.1万到14.3万人死于霍乱。霍乱是由霍乱弧菌引起的急性消化道传染病，这是一种毒性极强的疾病，可导致严重的急性水样腹泻。人在摄入受污染的食物或水后可能在12小时到5天出现症状。大多数感染霍乱弧菌的人不会出现任何症状。霍乱弧菌会在患者感染后1-10天出现在他们的粪便中，重新排放到环境中，从而可能感染其他人。在出现症状的人中，大多数是轻度或中度症状，少数出现急性水样腹泻并伴有严重脱水，若不及时治疗，可能导致死亡。霍乱弧菌有许多血清群，但只有O1群和O139血清群会引起霍乱，这两种血清群引起的疾病没有区别。在19世纪，霍乱从印度恒河三角洲的原始水库蔓延到世界各地。随后的六次大流行在各大洲造成数百万人死亡。当前的（第七次）大流行于1961年在南亚开始，1971年到达非洲，1991年到达美洲。目前，霍乱仍在许多国家流行。针对霍乱的治疗，大多数人可通过及时服用口服补液盐溶液(ORS)得到治疗。成年患者在第一天可能需要6 L的ORS来治疗中度脱水。有休克风险的严重脱水患者，需要快速静脉输液。还需给这些患者使用适当的抗生素以减少腹泻持续时间及补液量，并减少粪便中霍乱弧菌的排泄量和持续时间。不建议大量使用抗生素，以防产生抗菌素耐药性。通过早期和适当的治疗，病死率应保持在1％以下。针对霍乱的防控，多以口服霍乱疫苗来达到目的。目前共有三种经世卫组织资格预审的口服霍乱疫苗：来自赛诺菲巴斯德的Dukoral®和Shanchol™，以及韩国上市生物制药公司EuBiologics的Euvichol-Plus®。三种疫苗都需要两剂才能获得全面保护。参考资料：(1)霍乱-世卫组织：https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/cholera登记邮箱信息订阅E药经理人信息服务扫描二维码

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霍乱	印度	-	2009-01-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02145377 (Pubmed)	临床2期	霍乱	150	Shanchol Inactivated Oral Vaccine	壓餘製襯鹹觸餘衊選蓋(網選繭築艱糧觸簾鬱顧) = 選蓋鹽鹹壓艱膚廠繭範鏇遞選顧製積鬱膚構遞 (製廠鏇齋窪選壓範艱鏇 )	-	2017-12-01
NCT02027207 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	霍乱	204,700	Cholera Vaccine	廠簾顧構艱範餘觸壓選(憲獵繭顧觸簾簾選鏇淵) = 襯構鹹憲餘遞築鹹艱鹽衊積淵餘淵觸鏇齋夢糧 (製淵廠簾鏇構繭簾齋網 )	积极	2016-05-05
NCT02027207 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	霍乱	204,700	Placebo	-	积极	2016-05-05