Bharat Biotech’s Oral Cholera Vaccine (Hillchol) Successfully Completes Phase III Clinical Trials
Context:
- Cholera, a vaccine-preventable waterborne disease, continues to pose a threat, particularly in low- and middle-income countries.
- Global demand for oral cholera vaccines (OCVs) is approximately 100 million doses annually, with only a single manufacturer supplying currently.
- Bharat Biotech’s Hillchol (BBV131) aims to address shortages and improve affordability and accessibility.
Clinical Trial Details:
- Phase III trial: Double-blind, randomized, conducted across 10 sites in India involving 1,800 participants ranging from infants to adults.
- Comparison: Single-component OCV vs. comparator vaccine (Shanchol).
- Primary endpoint: ≥4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses.
- Secondary endpoints: Geometric Mean Titre (GMT) and safety assessment.
Key Findings:
- Hillchol induced a >4-fold rise in antibodies:
- Ogawa serotype: 68.3%
- Inaba serotype: 69.5%
- Demonstrated non-inferiority to Shanchol.
- Safety profile: Adverse events mild and comparable; well-tolerated across all age groups.
Significance / Implications:
- Hillchol paves the way for enhanced vaccine production, targeting up to 200 million doses annually from Bharat Biotech’s facilities in Hyderabad and Bhubaneswar.
- Single stable O1 Hikojima strain simplifies production and improves vaccine stability.
- Supports affordable, accessible vaccination in populations at high risk of cholera.
- Market authorization in India received, allowing imminent distribution.
Policy / Public Health Relevance:
- Strengthens India’s capacity for indigenous vaccine production and global contribution to OCV supply.
- Complements ongoing national and global immunisation efforts, addressing vaccine gaps in vulnerable populations.
- Aligns with WHO’s push for equitable access to essential vaccines in endemic regions.
Prelims / Facts for UPSC:
- Vaccine trade name: Hillchol (BBV131)
- Developer: Bharat Biotech, India
- Clinical trial phase: Phase III
- Comparator vaccine: Shanchol
- Target population: Infants to adults
- Annual global OCV demand: ~100 million doses
Updated - May 21, 2025 08:25 pm | The Hindu