Oral vaccines offer great promise as public-health measures to prevent disease in less-developed countries. CVD 103-HgR, a genetically engineered, attenuated, Vibrio cholerae 01 strain has proved effective in industrialised countries. We have assessed the safety, immunogenicity, and excretion of this live cholera vaccine in children in north Jakarta, Indonesia.

412 children aged 5-9 years received single doses of 5 × 10⁶, 5 × 10⁷, 5 × 10⁸, 5 × 10⁹, or 1 × 10¹⁰ colony forming units (CFU) of CVD 103-HgR or placebo (5 × 10⁸ inactivated Escherichia coli K-12) with buffer. All doses were well tolerated. The 5 × 10⁸ CFU dose, which is highly immunogenic in subjects in industrialised countries (> 90% seroconversion), elicited seroconversions of vibriocidal antibody in only 16% of Indonesian children. By contrast, a single 5 × 10⁹ CFU dose of vaccine resulted in high rates (75% and 87%) of seroconversion with two different batches of vaccine. A batch prepared with a centrifugation step gave significantly higher geometric mean titres (16-fold increase over baseline) than did a batch in which there was a filtration step between fermentation and lyophilisation (10-fold increase over baseline).

At a 5 × 10⁹ CFU dose, CVD 103-HgR is well tolerated and highly immunogenic in Indonesian children and should therefore be further investigated for use as a one-dose live oral cholera vaccine in developing countries.