India's first phase 3 dengue vaccine trial hits 50% enrolment mark, early data shows no safety concerns

Indian Express

5 days ago

India has reached the 50 per cent enrolment mark in its first phase 3 clinical trial for the indigenous tetravalent dengue vaccine, DengiAll, with over 7,000 participants randomised across 20 trial sites. Initial results show no safety concerns for the one-shot vaccine for the mosquito-borne viral disease, according to researchers.
Developed by Panacea Biotec Limited under a licensing agreement with the National Institutes of Health (NIH), the primary United States federal agency for biomedical research, DengiAll targets all four dengue virus subtypes and has shown promising results in earlier clinical trials.
The study, coordinated by the Indian Council of Medical Research (ICMR), seeks to recruit 10,355 volunteers aged 18-60, with follow-ups extending for two years post-vaccination. Participants will receive either the vaccine or a placebo. The trial has been approved by the Drug Controller General of India and aims to conclude enrolment by October.
DengiAll has a weakened form of all four dengue virus subtypes and the same virus composition as the vaccine developed by NIH, except for the inactive ingredients. The NIH also evaluated the vaccine in the US and the results were found to be promising in the early-stage clinical studies. A Phase I/II clinical trial conducted in India among humans revealed a balanced and robust immune response across all four dengue virus types. The vaccine was also found to be safe and well-tolerated, in the trial.
Multiple ICMR institutes are involved in the study to evaluate the efficacy, immunogenicity, and safety of DengiAll. The ICMR-National Institute of Translational Virology (NITVAR) and AIDS Research (formerly ICMR-NARI) is responsible for overall trial coordination and has recently been identified as a designated site for participant enrollment.
Dr Sheela Godbole, director, ICMR-NITVAR and national principal investigator of the trial, told The Indian Express that follow-up will be completed in the last quarter of 2027.
According to Dr Abhijit Kadam, national co-principal investigator, healthy adults from the 18-60 years age group are being screened after obtaining informed consent and subsequently randomised after assessing their eligibility as per the trial protocol.
Participants are being randomised to receive either the dengue vaccine or a placebo (2:1) and will be followed up for two years,' he added.
Dr Suchit Kamble, principal investigator for the NITVAR clinical trial site, explained further that symptoms of dengue infection are fever, headache, muscle, joint pains, rash, nausea and vomiting.
'Some of the infections could result in severe manifestations like bleeding and shock (sudden drop in blood flow) and may threaten the life of the patient. Currently, there is no specific treatment available for dengue fever, and there is only supportive treatment like fever management and adequate fluid intake. Prevention and control of dengue depend on mosquito control measures,' he said.
The 20 trial sites are located in the following cities: Chennai, Pune (with two sites), Mysuru, Hyderabad, Puducherry, Kochi, Jodhpur, Ranchi, Kolkata, Aligarh, Patna, Rohtak, Ludhiana, Bengaluru, New Delhi, Bhubaneswar, Rishikesh, Guwahati, and Faridabad. The research teams at these sites come from well-known medical institutions, including three affiliated with ICMR.
Dengue fever is one of the top 10 threats to global health, according to the World Health Organisation (WHO). India accounts for a large fraction of global dengue cases, and the disease is endemic (regularly occurring within an area or community) in certain regions. Dengue causes frequent outbreaks, often coinciding with the monsoon season. According to a recent report in The Lancet Regional Health-Southeast Asia, approximately 100-400 million infections occur globally each year.
Data from the National Centre for Vector Borne Diseases Control, Ministry of Health and Family Welfare, shows that till March this year, around 12,043 dengue cases were reported, while 2.3 lakh cases and 297 deaths were reported in 2024. Over the years, scientists have been working towards a safe and effective vaccine, as current prevention methods focus on mosquito control, which can be difficult to implement in densely populated areas.
Anuradha Mascarenhas is a journalist with The Indian Express and is based in Pune. A senior editor, Anuradha writes on health, research developments in the field of science and environment and takes keen interest in covering women's issues. With a career spanning over 25 years, Anuradha has also led teams and often coordinated the edition.
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