Bharat Biotech's typhoid vaccine rated high in latest human trials

Vaccine is safe, 100% immunogenic, and prevents 55% of typhoid infections in the challenge trial and up to 87% infections

Hyderabad-based vaccine maker Bharat Biotech on Monday announced that its next-generation typhoid vaccine, Typbar-TCV 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 model.

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 fever.

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.

Bill and Melinda Gates Foundation has been supporting Typhoid Vaccine Acceleration Consortium. Bharat Biotech is working with the Consortium in carrying out field trials in different countries to evaluate the efficacy of Typbar TCV.