Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201202000354245 Date of Approval: 01/02/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Bridging Trial of Bivalent Killed Oral Cholera Vaccine in Ethiopia
Official scientific 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 describing the background and objectives of the trial To confirm the safety and determine the immune response to the two dose-regimen of whole cell oral cholera vaccine (Shanchol®) among healthy adults and children in Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cholera,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Cholera
Purpose of the trial Prevention
Anticipated trial start date 12/03/2012
Actual trial start date
Anticipated date of last follow up 10/09/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 216
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size 4) Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group WC-OCV 1.5 ml orally on day 0 and day 14 28 days trial duration for each participant Killed bivalent whole cell-oral cholera vaccine 108
Control Group Placebo 1.5 ml orally on day 0 and day 14 28 day trial duration for each participant Non biologic placebo 108 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. a. The subject should be able to continue in the study for the next 4 weeks b. 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: a.Medical history b.Physical examination c.Clinical judgment of the investigator 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 1 Year(s) 999 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/12/2011 Federal Democratic Republic of Ethiopia Ministry of Science and Technology
Ethics Committee Address
Street address City Postal code Country
PO box 2490 Addis Ababa Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2011 Armauer Hansen Research Institute
Ethics Committee Address
Street address City Postal code Country
PO box 1005 Addis Ababa Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/10/2011 International Vaccine Institute
Ethics Committee Address
Street address City Postal code Country
SNU Research Park, San 4-8, Nakseongdae-dong, Gwanak-gu Seoul 151-919 Korea, Republic of
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of subjects given investigational product with any of the following adverse events (immediate adverse events, any severe adverse events, reactogenicity) Following investigational product dosing: 1) Adverse events within 30 minutes 2) Severe adverse events within 14 days 3) Reactogenicity within 3 days
Primary Outcome Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline 14 days after second dose (day 28)
Secondary Outcome 1. Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline 14 days after first dose (day 14)
Secondary Outcome 2. Geometric mean serum vibriocidal titers at baseline 1) 14 days after dose 1 (day 14) 2) 14 days after dose 2 (day 28)
Secondary Outcome Occurence of any severe adverse event 1) within 28 days after dose 1 (day 28, active monitoring) 2) within 28 days after dose 2 (day 42, passive monitoring)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Armauer Hansen Research Institute PO box 1005 Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
LG Electronics Seoul Korea, Republic of
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Vaccine Institute SNU Research Park, San 4-8, Nadseongdae-dong, Gwanak-gu Seoul 151-919 Korea, Republic of University
COLLABORATORS
Name Street address City Postal code Country
Armauer Hansen Research Institute PO Box 1005 Addis Ababa Ethiopia
Federal Ministry of Health, Ethiopia Addis Ababa Ethiopia
International Vaccine Institute SNU Research Park, San 4-8, Nakseongdae-dong, Gwanak-gu Seoul 151-919 Korea, Republic of
Shantha Biotechnics Limited Hyderabad India
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jemal Hussein jemaldr@gmail.com 0911248265
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Medical Doctor, Clinical Researcher
Role Name Email Phone Street address
Public Enquiries Zenebe Akalu zenebeakalu@yahoo.com 0921927966
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Medical Doctor, Clinical Coordinator
Role Name Email Phone Street address
Scientific Enquiries Jemal Hussein jemaldr@gmail.com 0911248265
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Medical Doctor, Clinical Researcher
Role Name Email Phone Street address
Scientific Enquiries Sachin N Desai notprovided@xx.com 0000000000000 International Vaccine Institute
City Postal code Country Position/Affiliation
Seoul Korea, Democratic People's Republic of
REPORTING
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Result URL Hyperlinks
Changes to trial information