Safety and Immunogenicity of Different Immunization Regimens of CVD 103-HgR Live Oral Cholera Vaccine in Soldiers and Civilians in Thailand

Abstract

Attenuated Vibrio cholerae oral vaccineCVD 103-HgR was well tolerated by 324 Thai soldiers and civilians. Most receiveda single 5 × 10⁸ cfu dose, while 40 each receivedone or two 5 × 109 cfu doses. Vibriocidal antibody (the best correlate of immunity) seroconversion was lower in soldiers than civilians (P < .001). Increasing the vaccinedose to 5 × 109 cfu raised the geometric mean titer (P < .001).Asecond 5 × 109 cfu dose one weeklater did not notably increase seroconversions. Likelihood of seroconversionwas inverselycorrelated with baseline vibriocidal titer (P < .001). CVD 103-HgR caused seroconversion in most subjects with baseline titers ⩽1:40, including 100% of civilians after one 5 × 10⁸ cfu dose, 79% of soldiers after one 5 × 10⁹ cfu dose, and 45% of soldiers after one 5 × 10⁸ cfu dose. In persons with elevatedbaseline titers, vibriocidal antibody seroconversion is not a sensitive measure of whether vaccine has boosted intestinal immunity; for such subjects,other measurements must be used. Study regimens in endemic areas should use a single 5 × 10⁹ cfu dose.