First-ever phase-three clinical trial for dengue vaccine initiated in India

New Delhi: The ICMR and Panacea Biotec have initiated the first-ever phase three clinical trial for developing a dengue vaccine in India, the Union Health Ministry said on Wednesday.

India's indigenous tetravalent dengue vaccine, DengiAll, has been developed by Panacea Biotec and the first participant in this trial was vaccinated on Wednesday at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak.

The phase three clinical trial will be conducted across 19 sites in 18 states and union territories, involving more than 10,335 healthy adult participants.

"The initiation of this phase three clinical trial for India's first indigenous dengue vaccine marks a critical advancement in our fight against dengue. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India's capabilities in vaccine research and development," Union Health Minister J P Nadda said.

"Through this collaboration between ICMR and Panacea Biotec, we are not only taking a step towards ensuring the health and well-being of our people but also reinforcing our vision of Atmanirbhar Bharat in the healthcare sector," he said.

Currently, there is no antiviral treatment or licensed vaccine against dengue in India.

The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes.

In India, all four serotypes of dengue virus are known to circulate or co-circulate in many regions, the ministry statement said.

The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials worldwide.

Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development.

The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work.

Phase one and two clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results, the statement said.

The trial, primarily funded by the ICMR with partial support from Panacea Biotec, is set to follow up with participants for two years.

Dengue is a major public health concern in India, ranking among the top 30 countries with the highest incidence of the disease.

The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organisation (WHO).

In India, approximately 75-80 per cent of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes, the statement said.

Among the 20-25 per cent of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalisation and mortality.

In adults, the disease can escalate into severe conditions like dengue hemorrhagic fever and dengue shock syndrome, the statement said.