A Phase 2 interventional study of PXVX0200 10E8 and PXVX0200 10E9 in Cholera, sponsored by University of Maryland, Baltimore. Completed at 1 site in Mali. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Prevention
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.
79 studies on the registry are indexed under Cholera; 11 are open to participants now.
This study's enrollment of 150 is below the median of 292 across 68 interventional studies indexed under Cholera.
Browse Cholera studies →University of Maryland, Baltimore is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 63 (69%) have results posted.
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Exclusion Criteria:
PXVX0200 10E8 on day 0; Placebo on day 14
Biological: PXVX0200 10E8 · Biological: Placebo
Placebo on day 0; PXVX0200 10E8 on day 14
Biological: PXVX0200 10E8 · Biological: Placebo
PXVX0200 10E9 on day 0; Placebo on day 14
Biological: PXVX0200 10E9 · Biological: Placebo
Placebo on day 0; PXVX0200 10E9 on day 14
Biological: PXVX0200 10E9 · Biological: Placebo
Two doses of Shanchol, on day 0 and day 14
Biological: Shanchol
Oral dose of PXVX0200 10E8
Oral dose of PXVX0200 10E9
Oral dose of sodium bicarbonate buffer
Licensed comparator
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
Plot seroconversion
To plot the seroconversion (≥ 4-fold increase over baseline), mean fold rise (comparing baseline titer with post-vaccination titer), and kinetics of serum IgG cholera antitoxin antibody following the ingestion of a single oral dose of PXVX0200 (CVD 103-HgR) containing ≥2 x10E8 cfu or ≥2 x10E9 cfu versus Shanchol™.
Time frame: Day 7, 14, 21, 28, 35 and 42
Assess reactogenicity
Assess tiredness, vomiting, loss of appetite, abdominal pain and headache
Time frame: For seven days after each dose of PXVX0200
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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