India's first dengue vaccine may soon head to the market
What's the story
The Phase-III clinical trial of India's first indigenous dengue vaccine, DengiAll, is nearing completion. The trial, sponsored by the Indian Council of Medical Research (ICMR) and Panacea Biotec, has enrolled around 8,000 participants so far. The final enrollment of some 10,500 participants is expected to be done by October across 20 centers in India.
Enrollment details
Trial underway in multiple cities
The Phase-III trial is being conducted at various centers in Pune, Chennai, Kolkata, Delhi, and Bhubaneswar. Out of the total participants, some have been given the vaccine while others have received a placebo. The trial is co-led by ICMR-National Institute of Translational Virology, AIDS research in Pune; National Institute of Epidemiology (NIE), Chennai; and National Institute of Virology, Pune.
Trial objectives
No safety concerns seen so far
The trial will follow participants for two years to assess the efficacy of this tetravalent dengue vaccine. This multi-center, double-blind, randomized, placebo-controlled trial began in August last year. The first participant was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak. So far, results from the Phase-1/2 trials have shown no safety concerns for this one-shot vaccine.
Vaccine development
Challenges in developing a successful vaccine
Developing a successful vaccine is challenging due to the need for good efficacy against all four serotypes of the dengue virus. These serotypes have low cross-protection against each other, allowing for repeated infections. The Union Health Ministry had previously said that the tetravalent dengue vaccine strain (TV003/TV005), developed by the National Institutes of Health (NIH), US, has shown promising results in clinical trials in Brazil.
Development progress
Panacea Biotec is at the most advanced stage
Panacea Biotec is one of three Indian firms to have received the strain and is at the most advanced stage of development. The company has extensively worked on these strains to make a full-fledged vaccine formulation and holds a process patent for this work. Dengue is a major public health concern in our country, ranking among the top 30 countries with the highest incidence of this disease.