Adverse events after oral vaccination against cholera with CVD103-HgR.

The goal of the present study was to evaluate the tolerability and acceptability of an oral cholera vaccine (CVD103HgR) in individuals preparing for travel to countries endemic for cholera. 2545 Austrian travelers between 6 months and 81.5 years of age received a single dose of CVD103HgR and were asked to complete a questionnaire for documentation of adverse events during a 7 day period post immunization. Events were recorded regardless of whether they were caused by concomitant vaccinations or other factors and thus, a causative relationship was not necessarily present. Despite this drawback and the possibility of overreporting this study has proven a low frequency in side effects and the good tolerability of CVD103HgR. Occasional gastrointestinal side effects (15% diarrhea, 8.1% nausea, 1.1% vomiting) were seen and were of mild character and probably a consequence of associated intake of sodium bicarbonate buffer. Other events (7% skin eruptions, 2.7% fever) were mild and considered as harmless (or not vaccine related). The results show that the oral cholera vaccine CVD103HgR was well tolerated and accepted by travelers.