The phase three clinical trial will be conducted across 19 sites in 18 states and union territories, involving more than 10,335 healthy adult participants.
“The initiation of this phase three 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,” Union Health Minister J P Nadda said.
DengiALL is a tetravalent dengue vaccine
DengiALL is a tetravalent recombinant live attenuated tetravalent candidate vaccine that targets all the 4 serotypes of Dengue that are prevalent across the world.
The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes.
In India, all four serotypes of dengue virus are known to circulate or co-circulate in many regions, the health ministry has said.
Dengue fever is complicated by its four distinct serotypes—DEN-1, DEN-2, DEN-3, and DEN-4. Each serotype is genetically unique, and prior infection with one serotype can enhance the risk of severe disease if later infected with a different serotype, a phenomenon known as
antibody-dependent enhancement.
“One of the key concerns in dengue vaccine development is the phenomenon of antibody-dependent enhancement (ADE), where antibodies from a previous dengue infection or vaccination can enhance the severity of a subsequent infection. By attenuating the virus carefully, NIH’s approach aims to minimize the risk of ADE while still providing effective immunity against all four dengue serotypes,” Panacea Biotec has said in a statement. The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials worldwide.
The first participant in this trial was vaccinated on Wednesday at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak.
(With inputs from PTI)