Study proves efficacy of Bharat Biotech s Typhoid vaccine
Hyderabad Oct 2 (IANS) Leading vaccine-maker Bharat Biotech on Monday announced that its next-generation typhoid vaccine Typbar-TCVÂ® has demonstrated its safety and efficacy in a high risk human challenge clinical study carried out at Oxford University.
The clinical studies produced 87 per cent effectiveness as per the trial results published in Lancet said the Hyderabad-based firm.
The study is the first to demonstrate that immunisation with Typbar-TCVÂ® is safe well tolerated and will have a significant impact on disease incidence in typhoid endemic areas that introduce the vaccine.
This study was conducted in 112 adult volunteers and used as "controlled human infection model".
According the study 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 of infections when using real life definitions of typhoid fever.
Efficacy data from this trial will help to fill a long existing knowledge gap regarding Vi-conjugate vaccines said a statement.
This data is highly significant since the currently available vi-ps typhoid vaccines cannot be administered to children below two years and do not confer long-term immunity.
"The results of this study and the 87 per cent 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 eight years " said Krishna Ella Chairman and Managing Director Bharat Biotech.
Typhoid is caused by the bacterium Salmonella Typhi and is responsible for around 20 million new infections and 200 000 deaths mainly in South and South East Asia and Africa each year.
The Product Summary File has been submitted to the World Health Organisation (WHO) for prequalification. WHO prequalification would allow the UNICEF to procure this vaccine for low-income countries where the disease burden is very high said the statement.
Typbar-TCVÂ® is currently licensed in India Nigeria and Nepal with registrations underway in over 30 countries including Malaysia Turkey Thailand Uganda Kenya Bangladesh Pakistan and Vietnam.