New Delhi: Phase-3 trial for a dengue vaccine developed by Panacea Biotech is likely to begin in a few months. The vaccine has been developed in collaboration with the Indian Council of Medical Research (ICMR), news agency ANI reported quoting an official.
The phase-3 trial is a randomised, double-blind, placebo-controlled trial. This means that participants are randomly assigned to receive either the vaccine or a placebo. Neither the participants nor the investigators will know who is receiving the vaccine and who is receiving the placebo.
“The trials are underway but they have not yet fully started because we are waiting for the company to make the product which could not be made three months ago. The company should be ready in August. So, those phase-3 trials should be initiated in a few months,” said Dr Rajiv Bahl, director general of ICMR, as quoted by news agency ANI.
The primary goal of the trial is to assess the efficacy of the vaccine in preventing dengue fever. The secondary endpoints of the trial will examine the safety of the vaccine. Dr Nivedita Gupta, head of ICMR’s communicable diseases department was quoted as saying that Panacea Biotech has already completed the phase-1/2 trials of the vaccine on healthy adults in India.
“We have some preliminary immunogenicity results also. So all the paperwork has been done and the approval for phase-3 randomised double-blind, placebo controlled trial from the Drugs Controller General of India (DCGI) has also been obtained in January. The trial will be conducted on 10,335 healthy adults aged 18-80 years at 20 sites,” Dr Gupta said as quoted by news agency PTI.
