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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102660004195 Date of Registration: 11/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mogode OCV Booster-dose Study (MOBS)
Official scientific title Understanding the magnitude and kinetics of the serological responses to killed Oral Cholera Vaccine (OCV) when given 2 to 3 years after an initial receipt of OCV in Cameroon
Brief summary describing the background and objectives of the trial Background: Currently, the Global Cholera Control Roadmap assumes that a vaccination campaign using two doses will be carried out in cholera hotspots and that an OCV (Oral Cholera Vaccine) campaign will be repeated after about 03 years in these hotspots. However, a protocol that will guide the booster vaccination is required. Objectives: To assess whether the immune response to one or two doses of OCV given 03 years after an initial dose can protect people of different age groups. Methods: This is an open label, age-stratified clinical trial to determine the kinetics of the serum antibody responses following a single or two booster doses of OCV. The study will be carried out in the Mogode Health District based in the Far North Region of Cameroon. The District has benefited in 2017 from a two-doses OCV immunization campaign. Participants will be screened and those eligible will be stratified per age group (<5 years, 5-14 years and >14 years) and according to the number of OCV doses received in 2017. They will be randomized to either arm A or arm B. Arm A will receive one OCV dose and arm B, two OCV doses. Blood samples will be collected at baseline and at a given periodicity after vaccine administration to assess the immune responses following the administered vaccine doses. Data will be analysed by estimating and comparing mean titres of antibodies at given periodicities. Results: This study is expected to determine whether the immune response following the administration of a single dose is equivalent to that of two doses in each age group and according to the number of doses received in 2017. Conclusion: Understanding human immunological responses after booster OCV administration will serve as evidence to guide the estimates of vaccine doses and resources when planning OCV booster vaccination campaigns. Key words: OCV, booster response, vaccination, cholera, kinetics, Cameroon. Funder: Wellcome Trust-Department for International Development grant 215663/Z/19/
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MOBS
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Cholera
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 15/02/2021
Actual trial start date 01/03/2021
Anticipated date of last follow up 31/10/2021
Actual Last follow-up date 28/07/2021
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants) 350
Recruitment status Completed
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 randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Two doses OCV administration One dose at day 0 and second dose at day 14 14 days Each eligible participant will receive two OCV doses, one dose at day 0 and the second dose at day 14 (accepted window up to day 16). 180 Dose Comparison
Experimental Group one OCV dose One dose at day 0 One day Each eligible participant will receive one dose at day 0. 180
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age ≥1 year at the time of the 2017 OCV campaign, stratified into different age groups 2. Living in the Mogode Health Area where the OCV campaign was carried out 3. Good health condition, without clinically significant medical history (by participant or guardian, in case of minor) 4. Not pregnant for female subjects (confirmed by a urine pregnancy test) 5. Available to participate for the study duration, including all planned follow-up visits for up to 42 days from the time of screening. 6. Signed informed consent 1. Presence of a significant medical or psychiatric condition (Examples include: Diagnosis and treatment of TB or HIV; renal insufficiency; hepatic disease; oral or parenteral medication known to affect the immune function , such as corticosteroids, other immunosuppressant drugs; or behavioural or memory issues) 2. Receipt of an investigational product (within 30 days before vaccination). 3. History of diarrhoea in 7 days prior to first dose of vaccine (defined as ≥3 unformed loose stools in 24 hours). 4. History of chronic diarrhea (lasting for more than 2 weeks in the past 6 months) 5. Current use of laxatives, antacids, or other agents to lower stomach acidity? 6. Planning to become pregnant in the next 2 months 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Year(s) 100 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 03/12/2020 Cameroon National Ethics Committee on Human Health Research
Ethics Committee Address
Street address City Postal code Country
Avenue Douala Manga Bell Yaounde 1937 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Early vibriocidal response Between day 4 and day 6
Secondary Outcome Geometric Mean titre of immune response Days 4, 9, 14 and 28 following administration of dose 1 for group A and dose 2 for group B
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mogode Health District Mogode Council street Mogode Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Euston Road, London NW1 2BE, UK London NW1 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Meilleur Acces aux Soins de Sante Mvolye street, Biyem-Assi Lac Yaounde 33490 Cameroon NGO
Secondary Sponsor International Department of Public Health Johns Hopkins University 615 N Wolfe St Suite E8527, Baltimore, MD 21205 Baltimore United States of America University
COLLABORATORS
Name Street address City Postal code Country
Johns Hopkins University 615 N Wolfe St Suite E8527, Baltimore, MD 21205 Baltimore United States of America
Ministry of Public Health Avenue Douala Manga Bell Yaounde Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jerome Ateudjieu jateudjieu@masante-cam.org +237699701011 Mvolye, Biyem-Assi Lac
City Postal code Country Position/Affiliation
Yaounde 33490 Cameroon Executive Director of Meilleurs Acces aux Soins de Sante
Role Name Email Phone Street address
Public Enquiries Jerome Ateudjieu jateudjieu@masante-cam.org +237699701011 Mvolye, Biyem-Assi Lac
City Postal code Country Position/Affiliation
Yaounde Cameroon Executive Director of Meilleurs Acces aux Soins de Sante
Role Name Email Phone Street address
Scientific Enquiries David A Sack dsack1@jhu.edu 4432878795 Baltimore, Maryland 21205
City Postal code Country Position/Affiliation
Baltimore E5537 United States of America Professor Department of International Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The investigation team is committed to share the summary results within the trial registration record within 12 months of the study completion date. Similarly, the database will be made available upon request. Clinical Study Report,Study Protocol By July 2024 Researchers will need to submit a request to the investigators detailing their plans for analysis. An email will be made available to contact the research team. A form will be made available to collect requests and provide responses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://dx.doi.org/10.13140/RG.2.2.13533.22241 Yes 29/06/2024 31/01/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/06/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://dx.doi.org/10.13140/RG.2.2.13533.22241
Changes to trial information