Phase 3 Trial of India's First Indigenous Dengue Vaccine, 'DengiAll,' Commences
核心洞察
The Phase 3 clinical trial for 'DengiAll,' India's first indigenous tetravalent dengue (搜索) vaccine developed by Panacea Biotec and ICMR, has begun at KIMS, Bhubaneswar.
The trial will assess the vaccine's efficacy against all four serotypes of the dengue (搜索) virus, addressing a critical need in a country where dengue is prevalent.
KIMS is the only site in Odisha and one of 18 sites across India participating in the Phase 3 trial, aiming to recruit over 500 participants in Bhubaneswar.
The Phase 3 clinical trial for India’s first indigenous dengue (搜索) vaccine, ‘DengiAll,’ has commenced at the Kalinga Institute of Medical Sciences (KIMS) in Bhubaneswar. This trial, a collaborative effort between Panacea Biotec and the Indian Council of Medical Research (ICMR), seeks to evaluate the efficacy of the tetravalent dengue vaccine across India.
Addressing a Critical Unmet Need
With no specific antiviral treatment or licensed vaccine currently available in India, the development of an effective dengue (搜索) vaccine is a public health priority. Dengue fever, caused by four distinct serotypes of the dengue virus (DENV-1 to DENV-4), poses a significant threat, as infection with one serotype does not confer immunity to the others. According to WHO, more than 129 countries have reported dengue viral disease by the end of 2023. India ranks among the top 30 countries with the highest incidence of dengue.
DengiAll: A Tetravalent Vaccine
The ‘DengiAll’ vaccine utilizes the tetravalent dengue (搜索) vaccine strain (TV003/TV005) originally developed by the National Institutes of Health (NIH), USA. Panacea Biotec, one of three Indian companies to receive the strain, has advanced the formulation and holds a process patent for its work. The vaccine is designed to provide protection against all four dengue serotypes, a crucial feature for effective dengue control in endemic regions.
Trial Design and Implementation
The Phase 3 trial involves 18 sites across 18 states in India, with KIMS being the only participating hospital in Odisha. The trial aims to recruit over 500 participants in Bhubaneswar. Dr. Sonali Kar, HoD of Community Medicine, is the Principal Investigator for the study, along with Dr. L. Mohanty, the HoD of the Dept. of Internal Medicine, Prof. Dr. Dipti Pattnaik; HoD of the Dept. of Microbiology, and Prof. Dr. Saurav Patra the Director of the Central Laboratory, KIMS, will oversee the operations, supported by an investigation team led by Prof. Dr. P.C. Samantaray. The Site initiation visit (SIV) started on August 29, where the ICMR team from various institutes of ICMR, Sponsor from Panacea Bio-tech and JSS as CRO for the study visited KIMS to guide the trial team on operating procedures of the trial.
Promising Earlier Results
Prior to this Phase 3 trial, Phase 1 and 2 clinical trials were conducted in 2018-19, yielding promising results. These earlier trials provided the necessary safety and immunogenicity data to proceed with the current efficacy trial. The successful completion of this Phase 3 trial could pave the way for the licensure and widespread use of ‘DengiAll’ in India, offering a crucial tool in the fight against dengue (搜索) fever.