NIBSC support meeting on cholera vaccine standardisation

In May representatives from academia, industry, regulatory agencies and the World Health Organization joined together to share their experiences with batch release testing of oral cholera vaccines.  

Organised by colleagues at the International Vaccine Institute (IVI) and NIBSC, and supported by the Bill and Melinda Gates foundation, the Meeting on International Standards for Oral Cholera vaccines saw experts review potency tests used for the batch release.

One of the key topics was the need for standards to harmonise the LPS inhibition ELISA, an in vitro assay commonly used for batch release, across manufacturers and regulatory agencies.   

Delegates at the meeting on International Standards for Oral Cholera Vaccines in Seoul, South Korea. Image Courtesy of the International Vaccine Institute (IVI-Seoul) 

During the meeting attendees agreed on the importance of developing reference reagents for coating antigens and primary detection antibodies used in this ELISA as well as a reference vaccine. Delegates highlighted the need for these reagents to be tested by a wide range of laboratories in an international collaborative study.

The proposed reference reagents will be filled and freeze-dried at NIBSC specialist manufacturing facility. Pending financial support, materials should be available within four to five years. The standards will support delivery of oral cholera vaccines for public health campaigns in Low and Middle Income countries and the management of the global WHO stock pile.