‘DengiAll’: ICMR to hold trial of dengue vaccine; AIIIMS, Bibinagar among shortlisted hospitals

New Delhi: The Indian Council of Medical Research (ICMR) is conducting a large-scale clinical trial of a new dengue vaccine, `DengiAll’.

All India Institute of Medical Sciences (AIIMS), Bibinagar, Telangana, is one of the hospitals where the trial will be conducted.

The development of a vaccine will help to fight against the mosquito-borne disease.

The Phase III, multicenter, randomized, double-blind, placebo-controlled study is evaluating the efficacy, immunogenicity, and safety of a single dose of the Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized).

The trial, one of the largest of its kind in India, has enrolled over 10,000 participants across 20 sites nationwide.

Almost 70% of the recruitment is completed. This study seeks to provide robust data on the vaccine's performance in the Indian population, where all four serotypes of the dengue virus are prevalent.

Key sites for the trial include:

JSS Medical College and Hospital, Mysuru, Karnataka

Bangalore Medical College & Research Institute, Bengaluru, Karnataka

All India Institute of Medical Sciences (AIIMS), Bibinagar, Telangana

Each of these sites has been allocated an approximate budget ranging from 1.3 to 1.5 crore Rupees to facilitate the extensive research and participant monitoring required for the study.

Background:

Dengue fever is a major public health concern in India, with thousands of cases reported annually. The disease can range from a mild fever to severe and life-threatening conditions like dengue hemorrhagic fever and dengue shock syndrome. Despite ongoing efforts to control mosquito populations, the incidence of dengue remains high, underscoring the urgent need for an effective vaccine.

While several dengue vaccines have been developed globally, their efficacy can vary depending on the local epidemiology and the predominant serotypes of the virus. A vaccine specifically tailored and tested for the Indian context is crucial to ensure its effectiveness and widespread adoption. The ICMR's "DengiAll" trial represents a significant step forward in this direction, offering a glimmer of hope in the battle against this debilitating disease.

The double-blind, placebo-controlled design of the study is a gold standard in clinical research, ensuring unbiased results by preventing both participants and researchers from knowing who receives the vaccine and who receives the placebo. This rigorous approach is expected to yield high-quality data that will be instrumental in the potential future approval and rollout of the "DengiAll" vaccine. The completion of this trial could pave the way for a new, powerful tool in India's public health fight against dengue.