Improved, affordable single strain whole cell-B subunit oral cholera vaccine

Purpose and goal

The goal has been to develop an improved, thermostable and affordable enterocoated capsule oral cholera vaccine (OCV), "Hillchol-B", based on lyophilized formalin-inactivated serotype Hikojima bacteria and recombinantly produced cholera toxin B subunit (rCTB). This has been accomplished at lab scale and a program launched for the further industrial development and clinical testing towards international licensing and WHO prequalification. The properties of Hillchol-B should make it highly attractive for use in the control of both epidemic and endemic cholera world-wide.

Expected results and effects

We have successfully developed at laboratory scale an improved, thermostable and affordable enterocoated capsule oral cholera vaccine (OCV), "Hillchol-B", based on lyophilized formalin-inactivated serotype Hikojima bacteria and recombinantly produced cholera toxin B subunit (rCTB). A program is launched for the further industrial development and clinical testing towards international licensing and WHO prequalification of the novel vaccine. Its properties should make Hillchol-B highly attractive for use in the control of both epidemic and endemic cholera world-wide.

Planned approach and implementation

The project plan, which has been accomplished at lab scale, has been: 1) to optimize fermentation and inactivation processes of the Hikojima V. cholerae O1 strain earlier developed here; 2) optimize strain and processes for rCTB production and purification; 3) Developing optimal dry formulation Hikojima-rCTB enterocoated tablet or capsule; 4) Establishing QC and QA release methods; 5) Demonstrating preclinical potency and stability; and 6) Initiating the further industrial development and clinical testing for international licensure and WHO prequalification of Hillchol-B .