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

Sub: Sci

Sec: Health

Context:

The Indian Council of Medical Research (ICMR) and Panacea Biotec Limited announced the start of India’s first-ever phase 3 clinical trial for a dengue vaccine on August 14, 2024.

Details:

The trial, conducted in collaboration with ICMR, will assess the efficacy of DengiAll, India’s indigenous tetravalent dengue vaccine developed by Panacea Biotec.
The first participant was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences in Rohtak, Haryana.
Currently, there is no antiviral treatment or licensed vaccine for dengue in India.
Developing an effective vaccine is complex, as it must achieve good efficacy across all four dengue virus serotypes, which co-circulate in many regions of India.

Development of the Dengue Vaccine- DengiAll:

The vaccine strain (TV003/TV005), originally developed by the U.S. National Institutes of Health, has shown promising results in preclinical and clinical trials globally.
Panacea Biotec, one of three Indian companies to receive this strain, has advanced to developing the vaccine and holds a patent for its process.
Phases 1 and 2 of the clinical trials were completed in 2018-19 and yielded promising results, according to the Health Ministry.

Dengue as a Public Health Concern:

Dengue (break-bone fever) is a viral infection that spreads from mosquitoes to people. It is more common in tropical and subtropical climates.
Dengue is a major public health issue in India, which is among the top 30 countries with the highest incidence of the disease.
According to the World Health Organization, the global incidence of dengue has been rising over the past two decades, with more than 129 countries reporting cases by the end of 2023.
In India, 75-80% of infections are asymptomatic, yet these individuals can still transmit the virus through mosquito bites.
Among symptomatic cases, children are at a higher risk of hospitalization and mortality, while adults can develop severe conditions like dengue hemorrhagic fever and dengue shock syndrome.
The dengue virus has four serotypes, with low cross-protection between them, leading to the possibility of repeated infections.