Hillchol® marks a revolutionary step in global cholera prevention, resonating with the vision of BBIL. Hillchol® is a novel, innovative single-strain Oral Cholera Vaccine (OCV) developed by Bharat Biotech International Limited in a global partnership with MSD-Wellcome Trust and Hilleman Laboratories. The active ingredient in Hillchol® is a formaldehyde-inactivated novel V. cholerae strain (O1 El Tor Hikojima serotype recombinant strain). It embodies the expression properties of Ogawa and Inaba strains within a single strain, exhibiting safety and robust immunity against cholera.
The manufacturing process has been scaled for better yields, ease, and efficiency while maintaining the vaccine's properties. Extensive clinical trials at each stage have demonstrated adequate immune response compared to a WHO-prequalified vaccine in terms of anti-Ogawa and anti-Inaba serotype antibody titres and lot-to-lot consistency.
It is administered in two 1.5 mL oral doses on Day 0 and Day 14, with an easy-to-use delivery system. It is intended for individuals of 1 year and above. For optimal efficacy, Hillchol® should be stored between +2°C and +8°C.
Key Features and Benefits:
- Proven efficacy: Robust immunity against cholera, which can significantly reduce cholera burden and severity, has been demonstrated at each step comparable to other OCVs.
- Ease of Administration: Oral delivery method made convenient for mass immunization campaigns.
- Broad Age Range: Safe for children and adults over the age of 1 year.
- Convenient Packaging: A Single dose respule, which can be conveniently packed for multiple doses for ease and precision in storage, transport and administration, has been designed.
- Single Strain Formulation: Single-strain use simplifies manufacturing and enables large-scale production while retaining protection.
- Engineered Strain: Utilizes a formalin-inactivated V. cholerae O1 El Tor strain with stable expression of Ogawa and Inaba O1 LPS antigens.
- Robust Antigen Expression: Maintains effective immunogenicity.
- Efficient Manufacturing: Scalable efficient production and broad coverage are possible as the components needed are simplified and minimized.
- Innovative Engineering: The novel partial inactivation of the WbeT gene of O1 El Tor Hikojima serotype complements vaccine effectiveness.
- Proven Foundation: Hillchol® stands as the carry forward work of Prof. Jan Holmgren (recipient of the Albert B. Sabin Gold Medal (2018) & 3rd IVI-SK Bioscience Park MahnHoon Award (2024), a Swedish pioneer who identified anti-cholera IgA, developed the world’s first effective oral cholera vaccine, and his teams’ radiant work on novel strains of Vibrio cholerae co-expressing the Inaba and Ogawa serotype antigens(Lebens et al, 2011), which formed the basis of this vaccine.
- Global Licensing and Development: Optimized for worldwide use and equitable distribution.