maker Bharat Biotech
on Monday announced that its next-generation typhoid
has demonstrated its safety and efficacy in a high-risk human challenge clinical study carried out at Oxford University. The clinical studies conducted on human subjects produced 87 per cent effectiveness according to the trial results published in Lancet, the company said.
The study is the first to demonstrate that immunisation with Typbar-TCV
is safe, well tolerated and will have a significant impact on disease incidence in typhoid
endemic areas that introduce the vaccine.
The study was conducted in 112 adult volunteers and used a controlled human infection
According to the study published in Lancet, the vaccine
is safe, 100 per cent immunogenic, and prevents 55 per cent of typhoid
infections in the challenge trial and up to 87 per cent infections, when using real-life definitions of typhoid
The data is highly significant since the currently available vi-ps typhoid
vaccines cannot be administered to children below 2 years of age, and do not confer long-term immunity. Typbar-TCV
can be administered to children below 2 years and does confer long-term immunity, according to Bharat Biotech.
"The company is pleased that the vaccine
has been found to be extremely effective in the first ever high-risk human challenge studies. The results of this study and the 87 percent effectiveness success endorse more than 10 years of R&D efforts to develop this vaccine
and various clinical trials that have been carried out over the past 8 years," Bharat Biotech
chairman and managing director Krishna Ella said.
The product summary file has been submitted to World Health Organisation
(WHO) for prequalification. WHO
prequalification would allow for UNICEF to procure this vaccine
for low-income countries where the disease burden is very high. Typbar TCV is currently licensed in India, Nigeria and Nepal, with registrations underway in Malaysia, Turkey etc among 30 other countries, the company said.