BCG REVACCINATION STUDY IN ADULTS ACROSS 23 STATES
BCG revaccination study targeting adults in 23 Indian states.
Conducted in “programme implementation study mode.”
Source: The Hindu
BCG Revaccination Study
- Target Groups:Focus on high-risk individuals: aged over 50, with prior TB, underweight adults, diabetics, smokers, and alcohol consumers.Phase-1 to start in Uttar Pradesh and Madhya Pradesh.
- Study Context and Concerns:
- No previous clinical trials in India;
- Global studies show mixed results on BCG revaccination
- Expert committee recommended a robust trial, but government opts for programmatic study.
- WHO currently doesn’t recommend BCG revaccination in adults.
- Concerns about the waning protective effect of a single BCG dose and the need for revaccination.
- Implementation Plan:
- Some districts used as an intervention arm, others as a control arm.
- TB incidence to be monitored over a couple of years.
Challenges:
- Challenges in Kerala due to field constraints and focus on closing immunization gaps post-pandemic.
- Limited evidence on efficacy; studies based on retrospective data analysis from 1968.
- Critics argue for a clinical trial first; WHO emphasizes a lack of current recommendations for widespread BCG revaccination.
- Lakhs of consenting participants from high-risk groups.
- Kerala, Bihar, Chhattisgarh, West Bengal, and Uttarakhand haven’t consented.
This programmatic study aims to address gaps in knowledge about BCG revaccination efficacy in adults, particularly in high-risk groups, while considering concerns and challenges posed by field constraints in some states.