India begins first phase 3 clinical trial of dengue vaccine

The Indian Council of Medical Research (ICMR) and Panacea Biotec have launched the first phase 3 clinical trial for a dengue vaccine in indiaAccording to a statement released by the Union Health Ministry on Wednesday, this trial marks an important milestone in the country’s efforts to combat denguea mosquito-borne viral disease that represents a serious health problem.

Panacea Biotec has developed the country’s first indigenous tetravalent vaccine. dengue vaccinecalled DengiAll. The vaccine was administered to the first participant on Wednesday at the Pandit Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences in Rohtak, Haryana. The phase 3 clinical trial will be conducted at 19 sites across 18 states and union territories, involving over 10,335 healthy adult participants.

Union Health Minister JP Nadda stressed the importance of this trial and said, “The initiation of this Phase 3 clinical trial for India’s first indigenous dengue vaccine marks a major breakthrough in our fight against dengue. It reflects our commitment to protect our citizens from this widespread disease and underlines India’s capabilities in vaccine research and development.”

Currently, India has no licensed antiviral treatment or vaccine for dengue. Developing an effective vaccine is particularly challenging because of the need for robust efficacy against all four serotypes of dengue virus, all of which are known to circulate or co-circulate in various regions of the country.

The quadrivalent dengue vaccine strain (TV003/TV005) used in DengiAll was originally developed by the National Institutes of Health (NIH) in the United States. This strain has shown promising results in preclinical and clinical trials globally. Panacea Biotec, one of the three Indian companies that have received this strain, has made significant progress in its development and holds a process patent for the vaccine formulation. Phase 1 and 2 clinical trials of this Indian vaccine formulation were completed in 2018-19, and yielded encouraging results.

The ongoing Phase 3 trial, funded primarily by ICMR with partial support from Panacea Biotec, will involve a two-year follow-up of participants to assess the efficacy and safety of the vaccine.

Dengue remains a major public health problem in India, with the country among the 30 countries with the highest incidence of the disease. The global incidence of dengue has been steadily increasing over the past two decades, and by the end of 2023, more than 129 countries had reported cases of dengue, according to the World Health Organization (WHO).

In India, approximately 75-80 percent of dengue infections are asymptomatic, meaning people can carry and spread the virus without showing any signs of illness. However, in the 20-25 percent of cases where symptoms are present, children are at especially high risk of hospitalization and mortality. In adults, dengue can lead to serious complications, including dengue hemorrhagic fever and dengue shock syndrome, which can be fatal.

The successful development and deployment of DengiAll could make a difference in India’s fight against dengue, potentially reducing the burden of the disease and preventing serious consequences in vulnerable populations.