[Translation] A single-center, dose-escalation, open-label phase I clinical trial to evaluate the safety and tolerability of a recombinant B subunit bivalent O1/O139 cholera vaccine (enteric-coated capsules)

初步评价低剂量和高剂量重组B亚单位双价O1/O139 霍乱疫苗（肠溶胶囊）在中国16-60周岁常住健康人群中免疫3次的安全性和耐受性。

[Translation]

To preliminarily evaluate the safety and tolerability of three immunizations of low-dose and high-dose recombinant B subunit bivalent O1/O139 cholera vaccine (enteric-coated capsules) in healthy Chinese residents aged 16-60 years.

Start Date04 Mar 2016

Sponsor / Collaborator

Shanghai United Cell Biotechnology Co. Ltd.

100 Clinical Results associated with Recombinant B-subunit/whole cell cholera vaccine(Shanghai United Cell Biotechnology Co. Ltd.)

100 Translational Medicine associated with Recombinant B-subunit/whole cell cholera vaccine(Shanghai United Cell Biotechnology Co. Ltd.)

100 Patents (Medical) associated with Recombinant B-subunit/whole cell cholera vaccine(Shanghai United Cell Biotechnology Co. Ltd.)

Literatures (Medical) associated with Recombinant B-subunit/whole cell cholera vaccine(Shanghai United Cell Biotechnology Co. Ltd.)

06 Sep 2017·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Study on the immunogenicity and safety of recombinant B-subunit/whole cell cholera vaccine infused with antacids in healthy population at ages of 2-6 years].

Article

Author: Li, R C ; Liu, D P ; Huang, T

Objective: To assess the immunogenicity and safety of recombinant B-subunit/whole cell cholera vaccine (rBS/WC) oral cholera vaccine (Ora Vacs) infused with antacids in healthy population at ages of 2-6 years. Methods: Between December 2009 and January 2010, we recruited 900 volunteers aged 2-6 years od through giving out recruitment notice for the eligible children's parents from different vaccination clinics of Chongzuo city in Guangxi Zhuang Autonomous Region. This study was a randomized, double-blind, placebo-controlled trial, and subjects were randomly (2∶1) assigned to receive Cholera vaccine infused with antacids or placebo, and observed for safety. Serum samples of 300 subjects in immunogenicity subgroups (200 for vaccine groups, 100 for control groups) before the 1st dose and 49 d (±3 d) after immunization were collected, and determined for antibody levels against the cholera toxin (anti-CT) and cholera vibriocidal (anti-Vab) with Enzyme-linked immunosorbent assays (ELISA), based on which the GMT was calculated. There were 266 cases paired with the serum samples before and after immunization (177 for vaccine groups, 89 for control groups). The comparison of subjects' age at enrollment and the level of GMT before and after immunization between groups were analyzed by t test. The superiority test for the difference between seroconversion rates of vaccine groups and control groups were analyzed by χ(2) test. Results: Of 900 subjects enrolled, the number of males and females were 503 and 397 respectively (vaccine groups 335 vs. 265, control groups 168 vs. 132), the average ages of vaccine groups and control groups at enrollment were (4.8±1.2) years and (4.9±1.2) years respectively. There were no significant differences between groups in terms of gender and age (χ(2)=0.00, P=1.000; t=0.55, P=0.585). The 2 times increase rates of anti-CT and anti-Vab in vaccine groups after inoculation were 90.96% and 57.63% respectively, which were superiority to those of control groups (15.73% and 29.21%), and significant differences were observed between groups (χ(2)=15.89, χ(2)=3.85, P<0.001). There were significant differences between vaccine groups and control groups after inoculation in terms of GMTs of anti-CT (1∶647.56 vs. 1∶99.49) and anti-Vab antibodies (1∶16.19 vs. 1∶11.27) (t values were 15.82 and 3.43, respetively; both P values were<0.05), significant differences were observed in the growth rates when compared the GMTs of anti-CT (6.63 vs. 1.11) and anti-Vab antibodies (1.64 vs. 1.16) before inoculation between vaccine groups and control groups (t'=17.85 and 4.96, P<0.001). In terms of safety, the adverse reaction rates in vaccine groups and control groups were 37.67% (226/600) and 36.67% (110/300), respectively,the common adverse reaction including fever, nausea, vomiting, abdominal pain, diarrhea, headache, fatigue, allergies, rash, etc; and the severity degree were mainly for level 1. Conclusion: Ora Vacs infused with antacids could produce an positive effect on immune response and safety.

01 Dec 2012·Biotechnology LettersQ4 · ENGINEERING & TECHNOLOGY

Effect of immunization with a recombinant cholera toxin B subunit/somatostatin fusion protein on immune response and growth hormone levels in mice

Q4 · ENGINEERING & TECHNOLOGY

Article

Author: Ruili Qi ; Weifen Li ; Jun He ; Taoyan Yuan ; Dong Niu ; Bingbing Wu ; Yan Fu

Somatostatin (SS) is a hormone that inhibits growth hormone secretion. Cholera toxin B subunit (CTB) is a widely used adjuvant to improve the immunogenicity of co-administrated antigen. To block the growth hormone-inhibiting effect of SS, a fusion gene of CTB and SS was constructed and expressed in Escherichia coli. The purified CTB/SS fusion protein polymerized into a biologically active pentamer required for CTB binding to the GM1 ganglioside receptor. Immunization with the CTB/SS protein induced specific immunity against CTB and SS in mice. The serum growth hormone of the CTB/SS-treated mice increased by 29 % (P < 0.05) compared with the control. The results indicated that the CTB/SS fusion protein was effective in inducing immune response against SS as well as elevating the growth hormone level.

01 Dec 2009·BMC Infectious DiseasesQ3 · MEDICINE

Effectiveness and economic analysis of the whole cell/recombinant B subunit (WC/rbs) inactivated oral cholera vaccine in the prevention of traveller's diarrhoea

Q3 · MEDICINE

ArticleOA

Author: Rosa Diez-Diaz ; Emilia Reina ; Rosa López-Gigosos ; Maria J Calvo ; Elena Plaza ; Pedro Garcia-Fortea

BACKGROUNDNowadays there is a debate about the indication of the oral whole-cell/recombinant B-subunit cholera vaccine (WC/rBS) in traveller's diarrhoea. However, a cost-benefit analysis based on real data has not been published.METHODSA cost-effectiveness and cost-benefit study of the oral cholera vaccine (WC/rBS), Dukoral for the prevention of traveller's diarrhoea (TD) was performed in subjects travelling to cholera risk areas. The effectiveness of WC/rBS vaccine in the prevention of TD was analyzed in 362 travellers attending two International Vaccination Centres in Spain between May and September 2005.RESULTSThe overall vaccine efficacy against TD was 42,6%. Direct healthcare-related costs as well as indirect costs (lost vacation days) subsequent to the disease were considered. Preventive vaccination against TD resulted in a mean saving of 79.26 euro per traveller.CONCLUSIONAccording to the cost-benefit analysis performed, the recommendation for WC/rBS vaccination in subjects travelling to zones at risk of TD is beneficial for the traveller, regardless of trip duration and visited continent.

100 Deals associated with Recombinant B-subunit/whole cell cholera vaccine(Shanghai United Cell Biotechnology Co. Ltd.)

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Indication	Country/Location	Organization	Date
Cholera	CN	Shanghai United Cell Biotechnology Co. Ltd.	24 Nov 2003
Diarrhea	CN	Shanghai United Cell Biotechnology Co. Ltd.	24 Nov 2003

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Indication	Highest Phase	Country/Location	Organization	Date
Turista	Preclinical	CN	Shanghai United Cell Biotechnology Co. Ltd.	04 Mar 2016

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