India’s First Dengue Vaccine on Its Way! Phase III Clinical Study Initiated

The initiation of the Phase III clinical trial for India’s first dengue vaccine was declared by the Indian Council of Medical Research (ICMR) and Panacea Biotec on Wednesday. This was publicized at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak ().

This breakthrough trial aims to assess the effectiveness of India’s indigenous tetravalent dengue vaccine, known as DengiAll.

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Union Minister of Health and Family Welfare Shri Nadda said: “The initiation of this Phase III clinical trial for India’s first indigenous dengue vaccine marks a critical advancement in our fight against dengue. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India’s capabilities in vaccine research and development.”

Highlighting the significance of the partnership between ICMR and Panacea Biotec in taking ahead the development of the dengue vaccine., the Union Health Minister noted that "Through this partnership, we are not only taking a step towards ensuring the health and well-being of our people but also reinforcing our vision of Atmanirbhar Bharat in the healthcare sector."

Currently, India has no antiviral treatment or licensed vaccine for dengue, making the development of an effective vaccine a complex and urgent need. The challenge lies in achieving high efficacy across all four serotypes of the dengue virus, which are known to circulate or co-circulate in many regions of the country ().

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Panacea Biotec Leads in Developing this Vaccine Formulation

The tetravalent dengue vaccine strain (TV003/TV005) was originally developed by the National Institutes of Health (NIH) in the United States. It has shown encouraging outcomes in both preclinical and clinical trials worldwide.

Among the three Indian companies who have obtained this strain, Panacea Biotec has progressed much ahead in developing a vaccine formulation. The company possesses a process patent related to this work. Clinical trials for phases I and II of the Indian vaccine formulation were conducted in 2018-2019, showing promising outcomes.

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Phase III Clinical Trial of the Vaccine

Panacea Biotec, in partnership with ICMR, will conduct the Phase III clinical trial at 19 sites within 18 States and Union Territories in India, and will include over 10,335 healthy adult participants.

The study, which is mainly financed by ICMR and receives some funding from Panacea Biotec, will monitor participants over a period of two years.

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Dengue represents a significant public health issue in India, positioning the country among the top 30 nations with the highest rates of the disease. The World Health Organization reports that approximately 75-80% of dengue infections in India are asymptomatic; however, these individuals remain capable of spreading the virus via Aedes mosquito bites. In the 20-25% of cases that exhibit clinical symptoms, children face a notably increased risk of hospitalization and mortality.

According to GlobalData, a data analytics and consulting company, the Asia-Pacific region leads the dengue fever market, accounting for over 50% of the clinical trials conducted as of July 2023.

References:

ICMR and Panacea Biotec begin first pivotal dengue vaccine trial in India - (https://www.clinicaltrialsarena.com/news/icmr-panacea-biotec-pivotal-trial-dengue-vaccine/)
ICMR and Panacea Biotec initiate the First Dengue Vaccine Phase 3 Clinical Trial in India with Indigenous Dengue Vaccine, DengiAll - (https://pib.gov.in/PressReleasePage.aspx?PRID=2045090)

Source-Medindia