The challenge lies in creating a vaccine with broad efficacy across all four serotypes of the dengue virus, which circulate or co-circulate in several regions across India.
Published Oct 19, 2024 | 4:37 PM ⚊ Updated Oct 19, 2024 | 4:37 PM
Kerala joins ICMR’s clinical trial for indigenous dengue vaccine. (iStock)
Kerala is now part of the 18 states and union territories participating in the Indian Council of Medical Research’s (ICMR) phase-3 clinical trial for an indigenous dengue vaccine.
The trial in the state will be conducted at the Amrita Institute of Medical Sciences, Kochi, as part of a nationwide initiative to develop a much-needed vaccine against dengue, a disease that has become a growing public health concern in India.
The Kerala Health Department has approved the trial, stipulating that all legitimate protocols must be strictly followed.
The trial launched in August 2024 at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, is now extended to 19 sites in 18 states and union territories.
The vaccine being tested— DengiAll— is a tetravalent dengue vaccine developed by Panacea Biotec, marking India’s first major effort to produce a dengue vaccine.
The vaccine strain (TV003/TV005) used in the study was originally developed by the National Institutes of Health (NIH) in the United States.
Panacea Biotec, one of three Indian companies licensed to work with the NIH strain, has made significant progress in formulating the vaccine and holds a process patent for the development.
ICMR, with partial funding support from Panacea Biotec, is conducting the trial, which will enrol 10,335 healthy adults aged between 18 and 60 years.
Participants will be monitored for two years to assess the vaccine’s efficacy, immunogenicity, and safety. This trial follows the successful completion of phase 1 and 2 trials in 2018-19, where promising results were reported.
While giving a nod for the vaccine trial, the study team has been directed by the Kerala Health Department to ensure transparency by properly briefing dengue patients or parents (in the case of minors) about the importance of developing the vaccine.
The privacy of the participants must be maintained throughout the process. Additionally, the institute must obtain informed written consent from participants or their parents (where applicable), adhering strictly to ethical and legal standards.
Currently, there is no antiviral treatment or licensed dengue vaccine in India, making the development of an effective vaccine an urgent necessity.
The challenge lies in creating a vaccine with broad efficacy across all four serotypes of the dengue virus, which circulate or co-circulate in several regions across India.
Repeated infections due to low cross-protection between the serotypes can result in severe conditions like dengue hemorrhagic fever and dengue shock syndrome.
With approximately 75-80 percent of infections being asymptomatic, individuals unknowingly contribute to the transmission of the virus through mosquito bites, exacerbating the spread of the disease. Children are particularly vulnerable, with severe infections often leading to hospitalization and, in some cases, death.
Kerala, along with states like West Bengal, Uttar Pradesh, Karnataka, Tamil Nadu, Gujarat, and Delhi, is among the worst-affected regions in the country.
Kerala has been grappling with a significant dengue burden in 2024. In 2024, the state reported 18,070 confirmed cases and 62 deaths, with a further 48,689 suspected cases and 57 suspected deaths.
Between 1-16 October alone, 893 cases and two deaths were recorded, underscoring the urgent need for preventive solutions.
Dengue has emerged as a major global health concern, with the World Health Organization (WHO) identifying it as one of the top ten global health threats in 2019.
The incidence of dengue has increased dramatically, with more than 129 countries reporting cases by the end of 2023.
Globally, 100-400 million infections occur annually, with over 80 percent being mild or asymptomatic. The phase-3 trial initiated by ICMR is expected to be a turning point in the fight against dengue in India.
An effective vaccine like DengiAll would help reduce the morbidity and mortality associated with the disease, providing much-needed relief to states like Kerala that experience regular outbreaks.
Dengue is a viral infection transmitted through the bite of infected Aedes mosquitoes, primarily Aedes aegypti, which are active during the day.
Found mostly in tropical and subtropical regions, dengue poses a risk to nearly half of the world’s population, with 100–400 million infections reported annually.
While many cases are mild or asymptomatic, symptoms such as high fever, severe headache, muscle pain, and rash may appear 4–10 days after infection.
Severe dengue, marked by abdominal pain, bleeding, and fatigue, can develop after the fever subsides, requiring urgent medical care. With no specific treatment, early detection and vector control remain critical in preventing fatalities.
(Edited by Sumavarsha Kandula)
