PHASE II STUDY REPORTS RESULTS OF ORAL CHOLERAGARDE
AVANT Immunotherapeutics has announced positive preliminary results from a Phase II clinical trial of CholeraGarde, its cholera treatment, in infants and children. The researchers found the single-dose, oral vaccine to be well-tolerated and highly immunogenic, with 77 percent of children aged 9 months to 5 years generating protective immune responses.
The ability to induce protective immune responses in children under age 2 would allow the introduction of the vaccine into the routine pediatric immunization calendar in endemic regions, the company said. There are currently no licensed cholera vaccines indicated for use in children under age two. Cholera remains a global threat according to the World Health Organization, especially in developing countries and to travelers. Infants, children and the elderly are at the highest risk of dying from the disease.
The double-blind, randomized, placebo-controlled study was conducted at the Center for Health and Population Research of the International Center for Diarrheal Disease Research, Bangladesh, in collaboration with Korea's International Vaccine Institute.
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