To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline. To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.
Currently there are two licensed inactivated vibrio oral vaccines (Dukoral® \[Crucell; Leiden, The Netherlands\] and Shanchol™ \[Shantha Biotechnics; Hyderabad, India\]) that are pre-qualified by the World Health Organization (WHO) for procurement by United Nations (UN) agencies. Each of these vaccines requires a two-dose regimen which is difficult to implement in the face of explosive outbreaks of cholera in unsettled situations in developing countries. For this reason there is great interest in identifying a cholera vaccine that can provide rapid onset of protection following the ingestion of just a single oral dose. This Phase 2 randomized, observer-blinded and subject-blinded clinical trial to be conducted in Bamako, Mali will assess the immunogenicity of the 10\^8 cfu versus the 10\^9 cfu formulation of PaxVax-manufactured CVD 103-HgR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
150
Oral dose of PXVX0200 10E8
Oral dose of PXVX0200 10E9
Oral dose of sodium bicarbonate buffer
Centre pour le Développement des Vaccins, Mali (CVD-Mali)
Bamako, Mali
To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination
A comparison of the ability of a single ≥2 x10E9 cfu oral dose versus a single ≥2 x10E8 cfu oral dose of PXVX0200 (CVD 103-HgR) versus placebo to elicit a significant (\> 4-fold) rise in serum Inaba vibriocidal antibody 14 days after vaccination, compared to baseline
Time frame: 14 days
To measure antibody response for a 10E8 dose and 10E9 dose of PXVX0200 oral vaccine
To compare the ability of a single ≥2 x108 cfu dose of PXVX0200 (CVD 103-HgR) or ≥2 x109 oral dose of PXVX0200 (CVD 103-HgR) versus Shanchol™ to elicit serum Inaba vibriocidal antibody mean fold rise (compared to baseline titer) and GMT
Time frame: 14 days
To plot the kinetics of the serum Inaba Vibriocidal antibody response
To plot the kinetics of the serum Inaba vibriocidal antibody response after ingestion of a single oral dose of PXVX0200 (CVD 103-HgR) containing ≥2 x10E8 cfu or ≥2 x10E9 cfu versus Shanchol™. (With GMT on the Y axis and time points on the X axis, the GMTs at baseline and at each post-vaccination time point will be connected as a line graph).
Time frame: Baseline and post-vaccination time point.
Assess fecal shedding of PXVX0200
Shedding of CVD 103-HgR in stool as determined by stool culture (whole specimen or rectal swab)
Time frame: Day 1-3, day 7 and day 14
Compare rate of diarrhea
To compare the rate of diarrhea (≥ 4 loose stools within 24 hours) following administration of each vaccine regimen versus placebo over 7 days of follow-up
Time frame: 7 days
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