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Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

Primary Purpose

Vibrio Cholerae, Cholera

Status
Completed
Phase
Phase 4
Locations
Ethiopia
Study Type
Interventional
Intervention
Killed Bivalent (O1 and O139) whole cell oral cholera vaccine
Placebo
Sponsored by
International Vaccine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vibrio Cholerae focused on measuring oral cholera vaccine, safety and immunogenicity, bridging study, ethiopia

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Armauer Hansen Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Killed oral cholera vaccine

Placebo

Arm 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

Non biologic placebo Ingredients Per 1.5 ml dose Starch 60mg Red color[1mg/ml] 10 µl Yellow color [1mg/ml] 5 µl Xanthum Gum (1% solution) 300 µl Water for Injection Upto 1.5 ml All the above ingredients are of pharmaceutical grade. Non-biological placebo of above composition has been used in 2010 for "Randomized, double-blind, placebo controlled trial to evaluate the safety and immunogenicity of orally administered, killed, bivalent whole-cell , cholera vaccine, Shanchol in Bangladeshi Adults and Children". This study involving 330 subjects was carried out at International Center for Diarrheal Disease Research Bangladesh (ICDDR,B) located in Dhaka, Bangladesh with Dr. Firdausi Qadri as Principal Investigator (NCT01042951). There were no safety concerns associated with this placebo in this study and the report of this study has been submitted to the National Regulators in Bangladesh and the World Health Organization.

Outcomes

Primary Outcome Measures

Proportion of subjects given investigational product with adverse events.
Immediate reactions within 30 minutes after each dose Serious Adverse Events occurring 14 days following each dose Reactogenicity: Headache, vomiting, nausea, abdominal pain/cramps, diarrhea, fever, loss of appetite within three days i. Diarrhea is defined as having 3 or more loose/watery stools within a 24 hour period. ii. Fever is defined as having an oral or axillary temperature of ≥ 38oC
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.

Secondary Outcome Measures

Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.
Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the investigational product.
Severe adverse event within 28 days following each dose of investigational product.

Full Information

First Posted
January 31, 2012
Last Updated
May 1, 2015
Sponsor
International Vaccine Institute
Collaborators
Armauer Hansen Research Institute, Ethiopia, Ministry of Health, Ethiopia, Shantha Biotechnics Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01524640
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Vaccine Institute
Collaborators
Armauer Hansen Research Institute, Ethiopia, Ministry of Health, Ethiopia, Shantha Biotechnics Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vibrio Cholerae, Cholera
Keywords
oral cholera vaccine, safety and immunogenicity, bridging study, ethiopia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Killed oral cholera vaccine
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Non biologic placebo Ingredients Per 1.5 ml dose Starch 60mg Red color[1mg/ml] 10 µl Yellow color [1mg/ml] 5 µl Xanthum Gum (1% solution) 300 µl Water for Injection Upto 1.5 ml All the above ingredients are of pharmaceutical grade. Non-biological placebo of above composition has been used in 2010 for "Randomized, double-blind, placebo controlled trial to evaluate the safety and immunogenicity of orally administered, killed, bivalent whole-cell , cholera vaccine, Shanchol in Bangladeshi Adults and Children". This study involving 330 subjects was carried out at International Center for Diarrheal Disease Research Bangladesh (ICDDR,B) located in Dhaka, Bangladesh with Dr. Firdausi Qadri as Principal Investigator (NCT01042951). There were no safety concerns associated with this placebo in this study and the report of this study has been submitted to the National Regulators in Bangladesh and the World Health Organization.
Intervention Type
Biological
Intervention Name(s)
Killed Bivalent (O1 and O139) whole cell oral cholera vaccine
Other Intervention Name(s)
Shanchol TM
Intervention Description
1.5 ml single dose oral administration on day 0 and day 14
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Non biologic placebo
Intervention Description
1.5 ml oral administration on day 0 and day 14
Primary Outcome Measure Information:
Title
Proportion of subjects given investigational product with adverse events.
Description
Immediate reactions within 30 minutes after each dose Serious Adverse Events occurring 14 days following each dose Reactogenicity: Headache, vomiting, nausea, abdominal pain/cramps, diarrhea, fever, loss of appetite within three days i. Diarrhea is defined as having 3 or more loose/watery stools within a 24 hour period. ii. Fever is defined as having an oral or axillary temperature of ≥ 38oC
Time Frame
6 months
Title
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.
Time Frame
6 months
Title
Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the investigational product.
Time Frame
6 months
Title
Severe adverse event within 28 days following each dose of investigational product.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 For females of reproductive age, non-pregnant (as determined by urine pregnancy test). Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years. Healthy subjects as determined by: Medical history Physical examination Clinical judgment of the investigator Exclusion Criteria: Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician. Ongoing acute illness. For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening) Immunocompromising condition or on chronic systemic steroid therapy Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment Intake of any anti-diarrhea medicine in the past week Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours Temperature ≥38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject Previous hypersensitivity to formaldehyde. Receipt of immunoglobulin or any blood product during the past 3 months Receipt of oral cholera vaccine in the past three years Any potential subject currently participating or who will participate within the next six months in another clinical trial Positive screening urine pregnancy test for females greater than 12 years of age
Facility Information:
Facility Name
Armauer Hansen Research Institute
City
Addis Ababa
State/Province
Oromia
Country
Ethiopia

12. IPD Sharing Statement

Citations:
PubMed Identifier
26078323
Citation
Desai SN, Akalu Z, Teshome S, Teferi M, Yamuah L, Kim DR, Yang JS, Hussein J, Park JY, Jang MS, Mesganaw C, Taye H, Beyene D, Bedru A, Singh AP, Wierzba TF, Aseffa A. A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia. Am J Trop Med Hyg. 2015 Sep;93(3):527-533. doi: 10.4269/ajtmh.14-0683. Epub 2015 Jun 15.
Results Reference
derived

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Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

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