Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine
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ClinicalTrials.gov Identifier: NCT02823899 |
Recruitment Status :
Completed
First Posted : July 6, 2016
Last Update Posted : November 2, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | June 22, 2016 | ||||
First Posted Date ICMJE | July 6, 2016 | ||||
Last Update Posted Date | November 2, 2018 | ||||
Actual Study Start Date ICMJE | July 2016 | ||||
Actual Primary Completion Date | November 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine | ||||
Official Title ICMJE | A Phase I/II Dose-escalation Study to Evaluate Safety, Tolerability and Immunogenicity of '2-dose Primary Series' Single Strain (Hikojima Serotype) Inactivated Oral Cholera Vaccine Formulations (Two Formulations Based on Total O1 LPS Content), in Sequential Age Descending Population of Healthy Adults and Children | ||||
Brief Summary | Cholera, a rapidly dehydrating watery diarrheal disease transmitted through water or food contaminated with the bacterium, Vibrio cholerae, is a major cause of morbidity and mortality in low income countries like Bangladesh. In our country, Cholera disease burden consists of both cholera outbreaks and endemic cholera comprising at least 300,000 severe cases and 1.2 million infections each year. To combat this situation, Vaccination against cholera has been proved effective both in endemic and epidemic settings. But, the WHO recommended Dukoral and Prequalified Shanchol are quite expensive for our country perspective. Therefore, locally manufactured OCV can improve the cost effectiveness and make it affordable for all. The hypothesis of this proposal is that Locally produced orally administered whole cell inactivated HL-OCV test formulations A and B are safe and immunogenic in adults and children in Bangladesh as compared to ShancholTM. The results of the study will allow us to understand the safety and immunogenicity outcome of the HL-OCV compared to Shanchol vaccine. The total sample size will be 840 healthy participants. 840 healthy participants (360 adults, 240 Children and Adolescent and 240 young children) of 18-45 years, 5- less than 18 years and 1 year to less than 5 years will be enrolled in the study. Children whose parents/guardians give voluntary consent will be enrolled in the study. The investigators will provide 2 dose of vaccine for three groups in 14 days interval. Test formulations will be locally manufactured and the comparator group will get Shanchol. The Investigators propose to collect three blood samples (Day 0, 14 and 28). | ||||
Detailed Description | Background : Cholera continues to be a major cause of morbidity and mortality in low income countries including Bangladesh. It is estimated that there are at least 300,000 severe cases and over 4,500 deaths in Bangladesh each year1. The overall morbidity for cholera remains high. A global stockpile of OCV has been created by WHO in 2013 for epidemic and outbreak settings30. However, the global demand for the vaccine far exceeds the present supply for both epidemic and also endemic settings3. It can be envisioned that local production of an affordable OCV for high risk population in endemic settings will improve the present scenario in Bangladesh and other countries. Knowledge gap: The WHO recommends OCV for use in both endemic and epidemic cholera settings4. At present there are two vaccines that are WHO prequalified. These include Dukoral which is registered in Bangladesh and in over 50 countries. However, the disadvantage of use of Dukoral is that its current price is expensive for Bangladesh and other developing countries. In addition, the need for buffer to formulate the vaccine makes it less fieldable for mass vaccination programs.Another whole killed OCV, ShancholTM, which is WHO prequalified, is based on similar bacterial components as Dukoral and licensed in India but not in Bangladesh. Although this vaccine is relatively affordable it may not be sufficiently cost effective for the Government of Bangladesh to implement it in our poor endemic settings. At present, the vaccine is in short supply and will not be able to meet the global demands. In order to increase supply of OCV and make the vaccine more affordable, MSD Wellcome Trust Hilleman Labs. Pvt. Ltd in collaboration with Goteberg University, Sweden has engineered new oral cholera vaccine HL-OCV,consisting of formaldehyde-inactivated recombinant V.cholerae strain ,MS 1568 expressing both Ogawa and Inaba antigens. The vaccine formulation is quantified on total O1 lipopolysaccharide ,LPS content which is matched to that of ShancholTM ,not less than 600 mcg/ml LPS for O1; Formulation A and higher than Shanchol ,not less than 900 mcg/ml LPS for O1; Formulation B. The vaccine technology is transferred to local manufacturer ,INCEPTA in Bangladesh. Relevance: The study of this locally manufactured new HL-OCV, among children and adults will be able to give us information regarding the safety and immunogenicity of two different formulations of vaccine, based on LPS content. The study will not only identify safe formulation among the two formulation A or B, but will also be able to show superiority of higher LPS formulation in most naive population in children who are 1-5 years of age. Results of the study will be able to identify and select most suitable formulation in Phase II study for licensure in Bangladesh. This study will further pave the way forward for field studies which could establish field efficacy of vaccine compared to existing vaccines in Bangladesh. Hypothesis : Locally produced orally administered whole cell inactivated HL-OCV test formulations A and B are safe and immunogenic in adults and children in Bangladesh as compared to Shanchol TM. Objectives: The objective of this study is to determine most safe and immunogenic formulation for new oral cholera vaccine HL-OCV, and comparing with licensed vaccine ShancholTM. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Cholera | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
840 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 2017 | ||||
Actual Primary Completion Date | November 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year to 45 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Bangladesh | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02823899 | ||||
Other Study ID Numbers ICMJE | PR-16021 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | International Centre for Diarrhoeal Disease Research, Bangladesh | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | International Centre for Diarrhoeal Disease Research, Bangladesh | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. | ||||
Investigators ICMJE |
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PRS Account | International Centre for Diarrhoeal Disease Research, Bangladesh | ||||
Verification Date | January 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |