Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

Cholera Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524640
• Other study ID #: CR-WC-09
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2012
• Last updated: May 1, 2015
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: International Vaccine InstituteEthiopia: National Regulatory AgencyEthiopia: Food Medicine and Administration and Control AuthorityEthiopia: Armauer Hansen Research Institute
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholera
• Vibrio Cholerae

Intervention

Biological:
• Killed Bivalent (O1 and O139) whole cell oral cholera vaccine
1.5 ml single dose oral administration on day 0 and day 14
• Placebo
1.5 ml oral administration on day 0 and day 14

Locations

Country	Name	City	State
Ethiopia	Armauer Hansen Research Institute	Addis Ababa	Oromia

Sponsors (4)

Lead Sponsor	Collaborator
International Vaccine Institute	Armauer Hansen Research Institute, Ethiopia, Ministry of Health, Ethiopia, Shantha Biotechnics Limited

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	Yes
Primary	Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.		6 months	No
Secondary	Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.		6 months	No
Secondary	Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the investigational product.		6 months	No
Secondary	Severe adverse event within 28 days following each dose of investigational product.		6 months	Yes