Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

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Brief Title

Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

Official Title

A Randomized, Double-blind, Controlled Trial to Evaluate the Safety and Immunogenicity of Killed Bivalent (o1 and o139) Whole-cell Based Oral Cholera Vaccine (Shanchol®) in Healthy Individuals in Ethiopia

Brief Summary

      This is a randomized, double blind, placebo controlled trial to confirm the safety and
      determine the immune response of the killed oral cholera vaccine in healthy adults and
      children in Ethiopia.

Detailed Description

      This study serves as a bridging trial to evaluate the safety and immunogenicity of a two dose
      regimen of the WC-OCV (Shanchol®) in Ethiopian population. In order to assess whether the
      bivalent killed oral cholera vaccine may be used safely among those who are most at risk for
      cholera, we need to determine the safety and immunogenicity of the killed oral cholera
      vaccine. The vaccine was evaluated in a large number of human subjects in India Vietnam, and
      Bangladesh, in which it has demonstrated safety, immunogenicity, and clinical protective
      efficacy. Though we do not expect the vaccine to act differently in the Ethiopian population,
      we aim to confirm our presumptive understanding that two doses of WC-OCV is safe and
      immunogenic in healthy volunteers at one year and above (exclusive of pregnant women).
      Findings from this study can pave the way for the possible use of the killed whole cell oral
      cholera vaccine in both endemic and outbreak settings at a larger scale.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Proportion of subjects given investigational product with adverse events.

Secondary Outcome

 Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.

Condition

Vibrio Cholerae

Intervention

Killed Bivalent (O1 and O139) whole cell oral cholera vaccine

Study Arms / Comparison Groups

 Killed oral cholera vaccine
Description:  Killed Bivalent (O1 and O139) Whole cell oral cholera vaccine (Shanchol TM) Vaccine strain Reformulated version
V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) of lipopolysaccharide (LPS) V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS

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

216

Start Date

December 2012

Completion Date

August 2013

Primary Completion Date

August 2013

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female adults aged 18 years and above; and children aged 1 -17 years who is
             available for follow-up visits and specimen collection.

               -  The subject should be able to continue in the study for the next 4 weeks

               -  The subject (or parent/guardian) should be willing to provide 3 blood samples

          2. For females of reproductive age, non-pregnant (as determined by urine pregnancy test).

          3. Written informed consent obtained from the subjects or their parents/guardians, and
             written assent obtained from children aged 12 - 17 years.

          4. Healthy subjects as determined by:

               -  Medical history

               -  Physical examination

               -  Clinical judgment of the investigator

        Exclusion Criteria:

          1. Ongoing chronic recurring illness which may cause systemic symptoms as judged by the
             investigating physician.

          2. Ongoing acute illness.

          3. For females of reproductive age: Pregnancy (or females planning to become pregnant
             during the study period; as determined by verbal screening)

          4. Immunocompromising condition or on chronic systemic steroid therapy

          5. Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks
             prior to enrollment

          6. Intake of any anti-diarrhea medicine in the past week

          7. Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours

          8. Temperature ≥38ºC (oral or axillary) warrants deferral of the vaccination pending
             recovery of the subject

          9. Previous hypersensitivity to formaldehyde.

         10. Receipt of immunoglobulin or any blood product during the past 3 months

         11. Receipt of oral cholera vaccine in the past three years

         12. Any potential subject currently participating or who will participate within the next
             six months in another clinical trial

         13. Positive screening urine pregnancy test for females greater than 12 years of age

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Location Countries

Ethiopia

Location Countries

Ethiopia

Administrative Informations

NCT ID

NCT01524640

Organization ID

CR-WC-09

Responsible Party

Sponsor

Study Sponsor

International Vaccine Institute

Collaborators

 Armauer Hansen Research Institute, Ethiopia

Study Sponsor

, ,

Verification Date

May 2015