(CTN News) – According to a senior official quoted by ANI, a phase-3 trial for a dengue vaccine developed by Panacea Biotech is expected to begin in a few months.
ICMR (Indian Council of Medical Research) has been collaborating with the vaccine development team in the development of this vaccine.
As part of the phase-3 trial, the participants will be randomly assigned to a double-blind, placebo-controlled trial.
As a result, participants are randomly assigned to receive a live vaccine or a placebo based on the Dengue Vaccine manufacturer’s instructions.
Participants and investigators will not be able to tell who is receiving the vaccine and who is receiving a placebo as neither will know who is receiving the vaccine.
We are currently in the process of conducting trials, but we have not yet begun fully, because we are waiting for the company to make the product that could not be manufactured three months ago.
The company is expected to have the product ready by August.
As a consequence, those phase-3 trials should be initiated within a few months, said Dr Rajiv Bahl, director general of ICMR.
A trial such as this one is designed primarily to determine if the vaccine is effective against dengue fever as a method of preventing this disease through the use of vaccination.
Aside from the primary endpoints of the study, the secondary endpoints of the study will focus on the safety and efficacy of the vaccine in addition to the primary endpoints.
ICMR’s communicable diseases department head, Dr Nivedita Gupta, has confirmed that Panacea Biotech has already completed its phase-1/2 trials on the vaccine on healthy adults in India, according to Dr Nivedita Gupta, head of Panacea Biotech’s communicable diseases department.
It is important to note that we have also received preliminary results on immunogenicity.
This means that we have completed all the paperwork and have obtained approval in January from the Drugs Controller General of India (DCGI) for a phase-3 randomised, double-blind, placebo-controlled trial.
According to Dr Gupta, the study will take place at 20 sites and involve 10,335 healthy adults between the ages of 18 and 80.
In many parts of the country, dengue is a significant public health problem as it is a mosquito-borne illness caused by four different viruses, which can be transmitted through the bite of a mosquito.
It is important to remember that dengue has a range of symptoms, from mild fevers to severe illnesses, such as dengue hemorrhagic fever.