Collaborative Clinical Trial for Oral Cholera Vaccine Launched
- Public-private collaboration among Incepta Vaccine, IVI, and icddr,b
- Following technology transfer from IVI to Incepta Vaccine, clinical trials to start in Dhaka, Bangladesh
The International Vaccine Institute (IVI), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), and Incepta Vaccine Ltd. announced today initiation of a clinical trial for Cholvax®, an inactivated oral cholera vaccine, in Dhaka, Bangladesh.The three groups are collaborating on its clinical development in order to register the vaccine in Bangladesh, the first oral cholera vaccine to be registered in the country.
The clinical trial will assess vaccine safety and immunogenicity in 2,052 people 1-45 years of age in Dhaka. As the trial sponsor, IVI will lead this research effort in collaboration with icddr,b, an international health research organization based in Bangladesh, and will also monitor the trial for quality assurance and provide technical support in data management and evaluation of participants’ safety and immune response to the vaccine. Incepta, the first human vaccine manufacturer in Bangladesh, will be responsible for manufacturing and quality control of clinical lots of Cholvax® for the trial. The trial is supported by the Bill & Melinda Gates Foundation.
The partnership between IVI and Incepta began in July 2014 when IVI transferred the technology for oral cholera vaccine production and quality control methods to the company. Both IVI and Incepta are committed to developing the vaccine for the public sector in Bangladesh where a high burden of cholera exists. This is the first collaboration between IVI and Incepta. The two organizations are also working together on the development of a typhoid conjugate vaccine.
The vaccine is a bivalent killed whole-cell oral cholera vaccine given orally in two doses over a 14-day interval and intended for use in people one year old and above. It was originally reformulated by IVI and developed through an international public-private partnership led by IVI, with partners from Sweden, India, Vietnam, and South Korea, and with support from the governments of South Korea and Sweden, and the Bill & Melinda Gates Foundation.
"The collaboration with Incepta and icddr,b will result in a vaccine that can reduce needless suffering of so many people from a debilitating and potentially fatal disease,” said Dr. Jerome Kim, IVI’s Director General, “This collaboration is critical to achieving our goal of making vaccines available and accessible for the world’s most vulnerable and impoverished people."