PXVX0200 (CVD103-HgR) vs Shanchol in Mali

Learn more about:
Related Clinical Trial
Preventative Intervention for Cholera for 7 Days Impact Study of Cholera Vaccination in Endemic Areas – Clinical Surveillance Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™ in Nepalese Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants Safety and Immunogenicity of Single Dose Choleragarde® in HIV-Seropositive Adults PXVX0200 (CVD103-HgR) vs Shanchol in Mali Cholera-Hospital-Based-Intervention-for-7-days A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Adults Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi Single Dose Azithromycin in the Treatment of Adult Cholera Safety and Immunogenicity of a New Formulation of Euvichol® Cholera Anti-Secretory Treatment Trial PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine Zinc Supplementation in Cholera Patients Immunologic Responses to a Live Attenuated Oral Cholera Vaccine Pilot Introduction of Oral Cholera Vaccine in Orissa, India Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200 Immunity to Human Cholera in Bangladesh Ciprofloxacin Multiple Dose for Adult Cholera Effect of Probiotic on Immunogenicity of Oral Cholera Vaccine Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo Protective Immunity to Human Cholera in Bangladesh Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine Oral Cholera Vaccine Delivery in Rural Bangladesh Study of Alternative Vaccination Schedule of Oral Cholera Vaccine Mass Oral Cholera Vaccination in Zanzibar Cholera Vaccine Investment Strategy in Bangladesh Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine Bridging Study for Killed Oral Cholera Vaccine in Ethiopia Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic Introduction of Cholera Vaccine in Bangladesh Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh Evaluation of a Boosting Regimen With Oral Cholera Vaccine Single Dose Azithromycin to Prevent Cholera in Children Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

Brief Title

PXVX0200 (CVD103-HgR) vs Shanchol in Mali

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

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.

Study Phase

Phase 2

Study Type


Primary Outcome

To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination

Secondary Outcome

 To measure antibody response for a 10E8 dose and 10E9 dose of PXVX0200 oral vaccine




PXVX0200 10E8

Study Arms / Comparison Groups

 PXVX0200 10E8 then placebo
Description:  PXVX0200 10E8 on day 0; Placebo on day 14


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

July 2014

Completion Date

March 2015

Primary Completion Date

March 2015

Eligibility 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

          -  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




18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Milagritos D Tapia, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

University of Maryland, Baltimore


 Emergent BioSolutions

Study Sponsor

Milagritos D Tapia, MD, Principal Investigator, University of Maryland, College Park

Verification Date

September 2019