WEDNESDAY, SEPTEMBER 28, 2016

Sanofi announces results of phase II C. diff vaccine

The vaccines division of French pharmaceutical company Sanofi announced on Monday that phase II of a new Clostridium difficile (C. diff) vaccine had favorable results.


The phase II trial produced immune responses in patients to C. diff toxins A and B, the strains that can potentially create life-threatening conditions. Reactions to the vaccine were generally short and mild.


The study was split into two stages with more than 650 volunteers between the ages of 40-75 who were at risk of C. diff infection. It discovered a significant increase of antibody production against C. diff in all age groups and dosing schedules.


"Like other toxoid vaccines such as tetanus, diphtheria and whooping cough, this investigational vaccine targets the symptom-causing toxins generated by C. diff bacteria and could be an important public health measure to help protect individuals from infection," Jamshid Saleh, who participated in the phase II trial, said.


The results of the phase II clinical trial helped to establish dosing levels for phase III, which began in August 2013 and includes 200 sites in 17 countries.


Patients usually come into contact with C. diff while hospitalized and receiving intravenous treatment. Infection can cause diarrhea, inflammation of the gut and, in some cases, death.


Paris-based Sanofi has developed vaccines for 20 infectious diseases.