SAFETY AND IMMUNOGENICITY IN NORTH AMERICANS OF A SINGLE DOSE OF LIVE ORAL CHOLERA VACCINE CVD 103-HGR - RESULTS OF A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND CROSSOVER TRIAL

We conducted a double-blind, placebo-controlled, randomized crossover study to evaluate the safety and immunogenicity of a single 5 x 10(8)-CFU dose of live oral recombinant cholera vaccine CVD 103-HgR in 94 North American adults. The vaccine was well tolerated without associated adverse reactions. Despite minimal fecal excretion of vaccine, 97% of subjects exhibited serum vibriocidal antibody and 72% had antitoxin responses.