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[A safety assessment on adverse reaction of recombinant B-subunit/inactivated whole cell oral cholera vaccine among non-infected population].

OBJECTIVE
To observe the safety of recombinant B-subunit/inactivated whole cell (rBS/WC) oral cholera vaccine among non-infected population.


METHOD
A method of double-blind and case control was conducted randomly. 3041 non-infected persons who aged from 5- to 60-years-old were divided randomly into 3 groups, including 2 vaccine groups and 1 placebo group. The vaccine and placebo were taken respectively by vaccine groups and placebo group on the 1st, 7th and 28th day in every months of sequential 3 months. The adverse reaction was observed in sequential 3 days after intaking orally. The follow-up interviews were conducted in 1, 2, 3 months.


RESULTS
No severe adverse reaction was occurred. The rate of adverse reaction was 1.70% in vaccine groups, 1.74% in placebo group. There was no statistically significant difference between two groups (chi2=0.013, P=0.909). The adverse reaction were mainly abdominal pain, diarrhea, partly anaphylaxis, and the others of dizziness, fatigue, weakness. Most people recovered within short time without any medical treatment. The adverse reactions might be related to psychogenic reaction.


CONCLUSION
The safety of oral rBS/WC cholera vaccine among non-infected population was pretty good.