First Dengue Vaccine Phase 3 Clinical Trial in India
Context:
The Indian Council of Medical Research (ICMR) and Panacea Biotec have initiated the first-ever Phase 3 clinical trial for India’s indigenous dengue vaccine, DengiAll.
- This trial represents a significant milestone in India’s efforts to combat dengue, a major public health concern.
- The trial will assess the efficacy of the tetravalent dengue vaccine developed by Panacea Biotec, marking a crucial step toward developing an effective solution against all four serotypes of the dengue virus in India.
- The trial’s initiation aligns with India’s vision of Atmanirbhar Bharat, aiming for self-reliance in the healthcare sector.
Relevance:
GS-03 (Science and technology)
Key Highlights:
1. Initiation of Phase 3 Clinical Trial:
- The first Phase 3 clinical trial for India’s indigenous dengue vaccine, DengiAll, has begun.
- The trial commenced with the first participant being vaccinated at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.
2. Vaccine Development:
- The tetravalent dengue vaccine strain (TV003/TV005) was originally developed by the National Institutes of Health (NIH), USA, and has shown promising results in previous trials globally.
- Panacea Biotec, one of three Indian companies to receive the vaccine strain, has advanced the vaccine’s development to this stage, holding a process patent for its formulation.
- Phase 1 and 2 trials conducted in India between 2018-2019 yielded positive results, paving the way for this Phase 3 trial.
3. Trial Details:
- The Phase 3 trial will be conducted across 19 sites in 18 States and Union Territories of India.
- It will involve more than 10,335 healthy adult participants, with a follow-up period of two years.
- The trial is primarily funded by ICMR, with additional support from Panacea Biotec.
4. Current Dengue Situation:
- Dengue is a significant public health issue in India, with the country ranking among the top 30 globally in terms of dengue incidence.
- All four serotypes of the dengue virus circulate in India, with 75-80% of infections being asymptomatic.
- Dengue can escalate into severe forms such as dengue hemorrhagic fever and dengue shock syndrome, particularly affecting children and adults.
Significance:
Indigenous Vaccine Development:
- The initiation of this trial represents a critical step in developing an indigenous solution to a pressing public health challenge.
- Success in this trial could lead to the availability of the first indigenous dengue vaccine, enhancing India’s self-reliance in vaccine production and aligning with the vision of Atmanirbhar Bharat.
Public Health Impact:
- An effective dengue vaccine would significantly reduce the disease burden in India, which is among the countries with the highest incidence of dengue.
- This vaccine has the potential to protect against all four dengue serotypes, addressing the issue of repeated infections and improving overall public health outcomes.
Global Relevance:
- As dengue continues to rise globally, India’s success in developing a tetravalent dengue vaccine could contribute to global efforts in combating the disease, positioning India as a leader in vaccine innovation and public health interventions.
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