PXVX0200 (CVD103-HgR) vs Shanchol in Mali

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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

Interventional


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

Condition

Cholera

Intervention

PXVX0200 10E8

Study Arms / Comparison Groups

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

Publications

* 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

Biological

Estimated Enrollment

150

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
             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
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Milagritos D Tapia, MD, , 

Location Countries

Mali

Location Countries

Mali

Administrative Informations


NCT ID

NCT02145377

Organization ID

HP-00059690


Responsible Party

Principal Investigator

Study Sponsor

University of Maryland, Baltimore

Collaborators

 Emergent BioSolutions

Study Sponsor

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


Verification Date

September 2019