The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.
Approximately 60 subjects and up to 120 household contacts will be enrolled in the United States. Vaccinees will be randomly assigned to receive either PXVX0200 or placebo in a 5:1 ratio and will be followed for 180 days postdose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
66
University of Kentucky
Lexington, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Safety
Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs
Time frame: Day 0-180
Immunogenicity
Immunogenicity as defined as rate of seroconversion (4-fold rise) of serum Inaba vibriocidal antibody and initial estimates of between subject variability of vibriocidal antibody response
Time frame: Day 0-28
Kinetics
Kinetics of serum Inaba vibriocidal antibody after 1 oral dose of CVD 103-HgR
Time frame: Day 0-28
Serum anti-cholera toxin (CT) IgG antibody conversion rates
Anti-cholera toxin IgG antibody conversion rates
Time frame: Day 0-28
Fecal shedding
Fecal shedding of CVD 103-HgR by vaccine recipient
Time frame: Day 0-7
Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts
Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts
Time frame: Day 0-28
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