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PXVX0200 (CVD103-HgR) vs Shanchol in Mali

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ClinicalTrials.gov Identifier: NCT02145377
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
PaxVax, Inc.
Shantha Biotechnics Limited
Information provided by (Responsible Party):
Milagritos Tapia, 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.


Condition or disease Intervention/treatment Phase
Cholera Biological: PXVX0200 10E8 Biological: PXVX0200 10E9 Biological: Placebo Biological: Shanchol Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2 Randomized, Double-Blinded Study to Compare in Malian Adults the Immunogenicity, Clinical Acceptability and Excretion Pattern Following the Ingestion of a Single Dose of PXVX0200 (CVD 103-HgR) Live Oral Cholera Vaccine Containing Either 108 Colony Forming Units [Cfu] or 109 Cfu Using Shanchol™ Killed Whole Cell Oral Cholera Vaccine as an Immunological Comparator
Study Start Date : July 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera

Arm Intervention/treatment
Experimental: PXVX0200 10E8 then placebo
PXVX0200 10E8 on day 0; Placebo on day 14
Biological: PXVX0200 10E8
Oral dose of PXVX0200 10E8

Biological: Placebo
Oral dose of sodium bicarbonate buffer

Experimental: Placebo, then PXVX0200 10E8
Placebo on day 0; PXVX0200 10E8 on day 14
Biological: PXVX0200 10E8
Oral dose of PXVX0200 10E8

Biological: Placebo
Oral dose of sodium bicarbonate buffer

Experimental: PXVX0200 10E9 then Placebo
PXVX0200 10E9 on day 0; Placebo on day 14
Biological: PXVX0200 10E9
Oral dose of PXVX0200 10E9

Biological: Placebo
Oral dose of sodium bicarbonate buffer

Experimental: Placebo then PXVX0200 10E9
Placebo on day 0; PXVX0200 10E9 on day 14
Biological: PXVX0200 10E9
Oral dose of PXVX0200 10E9

Biological: Placebo
Oral dose of sodium bicarbonate buffer

Active Comparator: Shanchol
Two doses of Shanchol, on day 0 and day 14
Biological: Shanchol
Licensed comparator




Primary Outcome Measures :
  1. To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination [ Time Frame: 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 :
  1. To measure antibody response for a 10E8 dose and 10E9 dose of PXVX0200 oral vaccine [ Time Frame: 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

  2. To plot the kinetics of the serum Inaba Vibriocidal antibody response [ Time Frame: 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).

  3. Assess fecal shedding of PXVX0200 [ Time Frame: 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)

  4. Compare rate of diarrhea [ Time Frame: 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


Other Outcome Measures:
  1. Plot seroconversion [ Time Frame: Day 7, 14, 21, 28, 35 and 42 ]
    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™.

  2. Assess reactogenicity [ Time Frame: For seven days after each dose of PXVX0200 ]
    Assess tiredness, vomiting, loss of appetite, abdominal pain and headache



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145377


Locations
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Mali
Centre pour le Développement des Vaccins, Mali (CVD-Mali)
Bamako, Mali
Sponsors and Collaborators
University of Maryland, Baltimore
PaxVax, Inc.
Shantha Biotechnics Limited
Investigators
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Principal Investigator: Milagritos D Tapia, MD University of Maryland, College Park
Principal Investigator: Samba O Sow, MD, MS Centre pour le Developpement des Vaccins - Mali

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Milagritos Tapia, Assistant Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02145377     History of Changes
Other Study ID Numbers: HP-00059690
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Milagritos Tapia, University of Maryland, Baltimore:
Cholera
Vaccine
Mali
Additional relevant MeSH terms:
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Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs