A Phase 1/2 interventional study of HL-OCV and Shanchol in Cholera, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 1 Year to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-02.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Phase 1/2, Interventional, and Prevention
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).
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.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's enrollment of 840 is above the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 206 studies on the registry; 31 are open to participants now.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pharmaceutical company in Bangladesh is now producing HL-OCV, with technological support from MSD wellcome trust Hilleman pt. ltd, which meets international Good manufacturing practice( GMP) standards and WHO production guidelines.
Biological: HL-OCV
The vaccine is manufactured by Shantha Biotechnics in hyderabad, India and is prequalified by the WHO. Shanchol is available in a single dose. This vaccine is used as two dose regimen.
Biological: Shanchol
Pharmaceutical company in Bangladesh is now producing HL-OCV, with technological support from MSD wellcome trust Hilleman pt. ltd, which meets international Good manufacturing practice( GMP) standards and WHO production guidelines.
The vaccine is manufactured by Shantha Biotechnics in hyderabad, India and is prequalified by the WHO. Shanchol is available in a single dose. This vaccine is used as two dose regimen.
Number of participants with vaccine related reactogenicity as assessed by study personnel.
Number of participants having reactogenicity events will be compared between test group and comparator group
Time frame: Within 30 minutes after administration of vaccine
Number of participants with solicited adverse events as assessed by study personnel
Number of participant having solicited adverse events observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group.
Time frame: Within 7 days after administration of vaccine
Number of participants with unsolicited adverse event including serious adverse event as assessed by study personnel.
Time frame: Within 14 days after administration of vaccine.
Number of participant showing seroconversion of vibriocidal antibody against serogroup O1 Inaba
Number of participants showing sero-conversion against V. cholerae O1 upon vaccination HL-OCV being tested in comparison with Shanchol TM .
Time frame: 14 days after administration of vaccine
Number of participant showing seroconversion of vibriocidal antibody against serogroup O1 Ogawa.
Number of participants showing sero-conversion against V. cholerae O1 upon vaccination HL-OCV being tested in comparison with Shanchol TM .
Time frame: 14 days after administration of vaccine
Plan to share: Yes — Data will be shared with MSD Wellcome Trust Hilleman Laboratories (P) Ltd.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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