ICMR/Panacea Biotec dengue vaccine starts advanced phase-3 trials

The Indian Council of Medical Research and Panacea Biotec have started advanced Phase III clinical trials for a dengue vaccine in India, with the first participant on the trial being vaccinated on Wednesday.

The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec, a note from the Union Health Ministry said, adding that the first participant on the trial was vaccinated at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.

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Union Health Minister JP Nadda said, “The initiation of this phase-3 clinical trial for India’s first indigenous dengue vaccine marks a critical advancement in our fight against dengue.” Presently, there is no antiviral treatment or licensed vaccine against dengue in India, the note said, adding that the development of an effective vaccine was complex due to the need to achieve 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 said. The four serotypes of the virus provide low cross-protection against each other, meaning individuals can experience repeated infections, the note added.

The ICMR and Panacea Biotec will conduct the phase-3 trials across 19 sites in 18 States and Union Territories across the country, and involving more than 10,335 healthy adult participants. The trial, primarily funded by ICMR with partial support from Panacea Biotec, is set to follow up with participants for two years.

Earlier this year, Japan’s Takeda had inked a partnership with India’s Biological E, involving its dengue vaccine QDENGA (TAK-003), to ramp up vaccine supplies.

Tetravalent vaccine

On the ICMR / Panacea Biotec trial, the note said, the tetravalent dengue vaccine strain (TV003/TV005), originally developed by the US National Institutes of Health (NIH), had 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 note said. “The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results,” it added.

Dengue is a 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 Organization (WHO). In India, approximately 75-80 percent of infections are asymptomatic, yet these individuals can transmit the infection through the bite of Aedes mosquitoes, the note said.

Among the 20-25 percent 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, it added.