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City-based vaccine maker Bharat Biotech on Tuesday announced that its Typbar-TCV, next-generation typhoid vaccine, demonstrated its safety and efficacy in a high-risk human challenge clinical study carried out at Oxford University.
Hyderabad: City-based vaccine maker Bharat Biotech on Tuesday announced that its Typbar-TCV, next-generation typhoid vaccine, demonstrated its safety and efficacy in a high-risk human challenge clinical study carried out at Oxford University.
This is the first clinical trial to show that immunisation with a Vi-TT (Typbar TCV) vaccine is safe, well tolerated, 100 percent immunogenic and halves the total number of typhoid infection cases in the challenge study, according to a release from Bharat Biotech.
The trial results were published in The Lancet. The vaccine turned out to be 87 percent effective for infants, older children and adults, under real life conditions, said the release. This study was conducted in 112 adult volunteers and used a controlled human infection model.
Dr Krishna Ella, CMD, Bharat Biotech, said: “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. The company has built dedicated facilities for the manufacture of this vaccine.”
According the study published in The Lancet, vaccine prevents 55 percent of typhoid infections in the challenge trial and up to 87 percent 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.
“This data is highly significant since the currently available Vi-PS typhoid vaccines can’t be administered to children below two years, and don’t confer long-term immunity. Typbar-TCV can be administered to children below two years of age and does confer long term immunity. Protection over a longer term reduces the need for repeat vaccinations,” further adds the statement.
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