Onset and Duration of Protective Immunity in Challenged Volunteers after Vaccination with Live Oral Cholera Vaccine CVD l03-HgR

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Abstract
CVD 103-HgR is a liveoral cholera vaccinethat, in phase I and II studies to date, has been well tolerated and immunogenic. In challenge studies of US volunteers conducted 4–5 weeks after vaccination, CVD 103-HgR provided significant protection against experimental cholera due to classical and El Tor Vibrio cholerae O1. To determine the onset and duration of protection, two volunteer challenge studies were conducted: the first, 6 months after vaccination and the second, 8 days after vaccination. In both studies, CVD 103-HgR was 100% protective against diarrhea and significantly reduced the rate of shedding of vibrios after challenge with V.cholerae classical Inaba strain 569B, the virulent parent strain of CVD 103-HgR. Previously vaccinated subjects were less likely than naive controls to develop rises in titer of vibriocidal antibodies after challenge (P = .002), and the mean peak titer of vibriocidalantibodies was less than among controls. CVD 103-HgR can provide homologous protective immunity as soon as 8 days after vaccination and protection can persist for at least 6 months.

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