PXVX0200 (CVD103-HgR) vs Shanchol in Mali
- Conditions
- Cholera
- Interventions
- Biological: ShancholBiological: PXVX0200 10E9Biological: PXVX0200 10E8Biological: Placebo
- Registration Number
- NCT02145377
- Lead Sponsor
- University of Maryland, Baltimore
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Able to understand the study and give consent (either written or through a process that involves audio tapes explaining all aspects of the study and the consent form in local languages [Bambara and French] followed by making a mark and signature by a literate witness)
- Healthy men or women, age 18 to 45 years (inclusive) without significant medical history
- Women of child-bearing potential must have negative urine pregnancy test at baseline, prior to vaccination. They must also be willing to use adequate birth control for the duration of the 28-day study and have additional pregnancy tests if indicated. Effective methods of birth control for this study include abstinence, intrauterine device (IUD), oral or depot contraceptive, or barrier plus spermicide
- Willingness to remain in the study area until at least 42 days after receipt of the first vaccine dose
- Health care workers who have direct contact with patients who are immune deficient, HIV-positive, or have an unstable medical condition
- Clinically significant history of immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurologic illness, psychiatric disorder requiring hospitalization, current drug or alcohol abuse
- History of an abnormal stool pattern or regular use of laxatives
- Previously received a licensed or investigational cholera vaccine
- History of cholera illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PXVX0200 10E9 then Placebo Placebo PXVX0200 10E9 on day 0; Placebo on day 14 Shanchol Shanchol Two doses of Shanchol, on day 0 and day 14 Placebo then PXVX0200 10E9 PXVX0200 10E9 Placebo on day 0; PXVX0200 10E9 on day 14 PXVX0200 10E8 then placebo PXVX0200 10E8 PXVX0200 10E8 on day 0; Placebo on day 14 PXVX0200 10E8 then placebo Placebo PXVX0200 10E8 on day 0; Placebo on day 14 Placebo, then PXVX0200 10E8 PXVX0200 10E8 Placebo on day 0; PXVX0200 10E8 on day 14 Placebo, then PXVX0200 10E8 Placebo Placebo on day 0; PXVX0200 10E8 on day 14 PXVX0200 10E9 then Placebo PXVX0200 10E9 PXVX0200 10E9 on day 0; Placebo on day 14 Placebo then PXVX0200 10E9 Placebo Placebo on day 0; PXVX0200 10E9 on day 14
- Primary Outcome Measures
Name Time Method To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination 14 days 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
- Secondary Outcome Measures
Name Time Method To measure antibody response for a 10E8 dose and 10E9 dose of PXVX0200 oral vaccine 14 days 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
To plot the kinetics of the serum Inaba Vibriocidal antibody response Baseline and post-vaccination time point. 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).
Assess fecal shedding of PXVX0200 Day 1-3, day 7 and day 14 Shedding of CVD 103-HgR in stool as determined by stool culture (whole specimen or rectal swab)
Compare rate of diarrhea 7 days 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
Trial Locations
- Locations (1)
Centre pour le Développement des Vaccins, Mali (CVD-Mali)
🇲🇱Bamako, Mali