Major milestone for India’s dengue shot as Phase 3 trials begin
India reported 289,235 dengue cases and 485 deaths in 2023, according to data the National Centre for Vector Borne Diseases Control Programme
The Indian Council of Medical Research (ICMR) and Panacea Biotec announced on Wednesday that they have started the first-ever Phase 3 clinical trial for its anti-dengue vaccine candidate in India; the country currently does not have an approved vaccine for the illness.
Dengue is a major public health concern in India and many parts of the world because of the large number of cases detected each year. India reported 289,235 dengue cases and 485 deaths in 2023, according to data shared by the National Centre for Vector Borne Diseases Control Programme.
The phase 3 trial is meant to evaluate the efficacy of the vaccine candidate — DengiAll. Developed by Panacea Biotec, DengiAll, is India’s indigenous tetravalent dengue vaccine that is designed to work on all four dengue strains. Globally, two dengue vaccines are licensed, Dengvaxia (CYD-TDV), developed by Sanofi Pasteur, and Qdenga (TAK-003), developed by Takeda. Both, however, are not yet approved for use in India for want of more data generated locally, according to people familiar with the matter. Dengvaxia’s use is limited by the fact that it is recommended only for those who have already been infected with the virus.
The first participant in the DengiAll trial was vaccinated on Wednesday at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, according to a statement from the Union ministry of health and family welfare .
India ranks among the top 30 countries with the highest incidence of the vector-borne viral disease. The global incidence of dengue has been steadily increasing over the past two decades, with at least 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organization (WHO).
Commenting on the milestone, the 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. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India’s capabilities in vaccine research and development. 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.”
In India, approximately 75-80% of infections are asymptomatic, yet these individuals can still transmit the infection through the f Aedes mosquitoes. Among the 20-25% of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalization and mortality. In adults, the disease can escalate into severe conditions such as dengue hemorrhagic fever and dengue shock syndrome. The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections.
The highest number of dengue cases was recorded in 2023, affecting at least 80 countries in all regions of WHO. Since the beginning of 2023, ongoing transmission, combined with an unexpected spike in dengue cases, resulted in a historic high of about 6.5 million cases and nearly 7300 dengue-related deaths reported.
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 tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), US, 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 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results,” read the health ministry statement.
In collaboration with ICMR, Panacea Biotec will conduct the Phase 3 clinical trial across 19 sites in 18 States and Union Territories, involving at least 10,335 healthy adult trial participants. According to the study design, the trial, primarily funded by ICMR with partial support from Panacea Biotec, is set to follow up with participants for two years.