India’s first dengue vaccine candidate, DengiAll, has reached a significant milestone with the enrolment of over 7,248 participants in its Phase 3 clinical trial. Launched on August 14, 2024, the trial is a collaborative effort between the Indian Council of Medical Research (ICMR) and Panacea Biotec. The developers designed the tetravalent vaccine to protect against all four known dengue virus serotypes.
Global Origins, Indian Innovation
As reported by The Hindustan Times, the vaccine strain (TV003/TV005) was originally developed by the US National Institutes of Health (NIH), which later sub-licensed the technology to companies worldwide, including Panacea Biotec and Indian Immunologicals. Among these, Panacea Biotec has progressed the furthest, having completed Phase 1 and 2 trials in 2018–19 and developed a complete vaccine formulation with a process patent.
Robust Clinical Trial Underway
The ongoing multi-centre, double-blind, randomized, placebo-controlled Phase 3 trial is being conducted across 19 clinical sites in India. It aims to recruit a total of 10,355 healthy volunteers aged 18–60 years. The study has received all regulatory clearances from the Drug Controller General of India (DCGI), and participant monitoring will continue for two years. Researchers will submit the final data to the Central Drugs Standard Control Organisation (CDSCO) for review. They expect to conclude enrolment by October 2025.
A Step Toward Vaccine Self-Reliance
Dr. Shrikant Tripathi, Research Head at Dr. DY Patil Vidyapeeth, Pune, said, “India is conducting its first-ever Phase 3 dengue vaccine trial. ICMR is primarily funding the trial, with partial support from Panacea Biotec, and no external agencies are funding it. This effort showcases India’s commitment to vaccine self-reliance.”
Urgent Need for a Vaccine Amid Rising Dengue Cases
Dr. Rajesh Karyakarte, Head of Microbiology at B J Medical College, Pune, highlighted the growing burden of dengue in India. “India accounts for nearly a third of global dengue cases. With climate change, shifting monsoon patterns, and increasing humidity, outbreaks are becoming more frequent. He said, “DENV-2, which links to severe cases like dengue haemorrhagic fever, now dominates.” He stressed that India urgently needs a safe and effective dengue vaccine to protect communities and reduce hospitalisations.
No Fixed Timeline for Efficacy Endpoint
Panacea Biotec stated that the efficacy timeline depends on the natural transmission rate of dengue. DengiAll is designed to stimulate immune responses against all four dengue strains. Once authorities approve the vaccine, India may include it in the national immunisation programme. Currently, the programme excludes a dengue vaccine for both children and adults.
SII’s Dengusiil Prepares for Phase 3 Trials
Meanwhile, the Serum Institute of India (SII) is preparing to launch Phase 3 trials of its own tetravalent dengue vaccine, Dengusiil. Earlier trials in adults and children demonstrated high immunogenicity and no serious side effects. SII will involve around 10,000 children aged two to under 18 years in the upcoming trial, taking into account regional variations in dengue prevalence. The institute expects to begin the trial by the end of 2025 and plans to conduct the study over four to five years.
Collaborative Efforts Continue
SII signed a memorandum of understanding with ICMR for the Dengusiil trial. Once CDSCO approves the protocols, the team will finalise the study sites and submit them for review.
India’s dual-track effort to develop an indigenous dengue vaccine—through DengiAll and Dengusiil—is a major step forward. It strengthens public health preparedness and helps reduce the burden of vector-borne diseases.