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.: PACTR202206663504683 Date of Approval: 02/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title OCV_Delayed Protocol
Official scientific title Immune Response to a Delayed Second Dose of Oral Cholera Vaccine
Brief summary describing the background and objectives of the trial Manufacturers of oral cholera vaccine (OCV) recommend a 7- or 14-days interval between two doses. To carry out two rounds of mass vaccination within this delay is not always feasible and many campaigns implemented to date have used a longer interval. Recent evidence indicates that an extended interval between OCV doses might result in equivalent seroconversion rates and in an improved boosting of mucosal immune responses following the second dose. To guide future OCV vaccination campaigns and improve cholera prevention, it is important to demonstrate the non-inferior immune response of an extended interval between OCV doses. We aim to demonstrate the non-inferiority of the humoral immune response between individuals receiving a second Euvichol-Plus® pre-qualified OCV dose either 6 or 12 months after the initial dose and individuals receiving a second pre-qualified OCV dose 14 days after the initial dose. The humoral immune response will be assessed as the post-vaccination titer of serum vibriocidal antibodies at 14 days post-2nd dose vaccination. Secondary outcomes include the comparison of the overall rate of vibriocidal seroconversion 14 days after either the first or the second vaccine dose. A subsample of individuals ≥ 18 years will have additional serological evaluation to characterize the kinetics of their antibody responses up to 6 months after the second OCV vaccine dose. Although the vaccine has an established and safe profile, occurrence of adverse events and serious adverse events following vaccination will be assessed (safety evaluation).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 15/06/2022
Actual trial start date 20/07/2022
Anticipated date of last follow up 15/06/2024
Actual Last follow-up date 26/08/2024
Anticipated target sample size (number of participants) 456
Actual target sample size (number of participants) 456
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vaccine This intervention arm will modify the recommended interval for administration of the second Euvichol-Plus®, which will be extended to 6 months. second dose at 6 months The intervention arms (6 and 12 months) will modify the recommended interval for administration of the second vaccine dose, which will be extended to 6 and 12 months according to the intervention arm. 152
Experimental Group Vaccine This intervention arm will modify the recommended interval for administration of the second Euvichol-Plus®, which will be extended to 12 months. second dose at 12 month The intervention arms (6 and 12 months) will modify the recommended interval for administration of the second vaccine dose, which will be extended to 6 and 12 months according to the intervention arm. 152
Control Group oral cholera vaccine Participants will receive the oral cholera vaccine, Euvichol-Plus®, according to the manufacturer instructions: 2 doses two weeks apart. standard second dose at Day 14 standard second dose at Day 14 152 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any healthy individual ≥ 1 year-old and younger than 40 years old , eligible for OCV vaccination (not suffering from a medical condition that contraindicates vaccination, i.e. any acute illness, including acute gastrointestinal illness or acute febrile illness). Living in the study area with no plan to move away over the study period (up to 18 months). Who provided written informed consent or whose representative (mother, father or main caretaker) provided written informed consent in case of individuals younger than 18 years. A written assent will also be obtained from adolescents (10-17 years) An individual who (or whose mother, father or main caretaker) is, based on the judgment of the investigator, capable of complying with the study requirements. Known history of hypersensitivity reactions to other vaccines. Individual acutely ill or with signs of infection at the time of enrolment (e.g. fever > 38⁰C) Gastrointestinal symptoms including nausea, vomiting, diarrhea, or decreased appetite within 24 hours prior to study initiation . Diarrhea, administration of antidiarrheal drugs or antibiotics to treat diarrhea or abdominal pain either lasting 2 weeks or longer within 6 months prior to study initiation, or occurring during the week before study initiation. Other vaccination within 1 week prior to study initiation or planned vaccination during the following month after vaccine intake . Participation in another trial with investigational product within 1 month prior to study initiation. Pregnant (as determined by a urine test on the day of each vaccination) or lactating women, women of reproductive age planning pregnancy before the end of the study period (up to minimum 18 months). An individual thought to have difficulty participating in the study due to other reasons (such as mental disorders, alcohol or drug intoxication), based on the judgment of the investigator. History of cholera vaccination or history of cholera as diagnosed by a medical person in a health facility (with or without laboratory confirmation). Severe chronic diseases or medical conditions, based on the medical judgment of the investigator, such as known low hemoglobin level or symptomatic anemia, severe acute malnutrition, chronic infection (e.g. tuberculosis), sequel of poliomyelitis, immunodeficiency due to symptomatic HIV/AIDS. Based on participant verbal reporting of the participant at inclusion, more than two persons in households <5 persons or three participants in households ≥ 5 persons. Although unlikely to be diagnosed in low-income countries: Thrombocytopenia or bleeding disorders or other known contraindication to venipuncture. see protocol Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 40 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 12/05/2022 CNERS Comite National d Ethique pour la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
Conakry Conakry 00 Guinea
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 03/05/2022 MSF ERB Ethics Review Board
Ethics Committee Address
Street address City Postal code Country
46 rue de l arbre benit Brussels 00 Belgium
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 27/09/2021 Mass General Brigham IRB
Ethics Committee Address
Street address City Postal code Country
399 Revolution Drive SUite 710 Somerville 02145 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum vibriocidal antibody GMT specific to V. cholerae O1, Inaba, Ogawa and O139 strains The primary analysis will compare the serum vibriocidal antibody GMT 14 days after the administration of the second OCV dose among the control arm (short, 14-day dosing interval of OCV administration) and the intervention arms (long, 6 and 12 months dosing intervals of OCV administration). Just before and 14 days after the administration of the first and the second OCV dose
Secondary Outcome Kinetics of the immune response to vaccination. All the primary and secondary outcomes will be measured at additional time points in a subset of the participants aged ≥18 years in the control and intervention arms At 4, 7, 28 and 180 days after the administration of the first and the second OCV doses
Secondary Outcome Safety and reactogenicity All participants will be observed for 30 minutes after each vaccination to monitor for any immediate adverse events (IAEs). The occurrence of IAEs, AEs and SAEs will be assessed in each vaccine arm. 30 minutes post vaccination, AEs up to 14 days after the administration of the first and the second OCV dose, and, for SAEs, up to the end of follow-up
Secondary Outcome Immune responses directed against the Inaba, Ogawa and O139 OSP Just before and 14 days after the administration of the first and the second OCV dose
Secondary Outcome Serum GMT for specific antibodies against the CtxB Just before and 14 days after the administration of the first and the second OCV dose
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dixinn MSF OCB Conakry, Republic of Guinea Conakry Guinea
FUNDING SOURCES
Name of source Street address City Postal code Country
Grieg Fondation Grieg-Gaarden PO Box 234 Sentrum Bergen Norway
MSF OCB 46 Rue de l arbre Benit Brussels 1050 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MSF OCB NA Brussels 1050 Belgium Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health Guinea ANSS Conakry Conakry Guinea
The General Hospital Corporation dba Massachusetts General Hospital 55 Fruit Street Boston United States of America
Epicentre 34 Avenue jean jaures Paris France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fabienne Nackers Fabienne.Nackers@brussels.msf.org +3224747501 46 rue de l arbre benit
City Postal code Country Position/Affiliation
Brussels Belgium PI
Role Name Email Phone Street address
Public Enquiries Fabienne Nackers Fabienne.Nackers@brussels.msf.org +3224747501 46 rue de l arbre benit
City Postal code Country Position/Affiliation
brussels Belgium PI
Role Name Email Phone Street address
Scientific Enquiries Fabienne Nackers Fabienne.Nackers@brussels.msf.org +3224747501 46 rue de l arbre benit
City Postal code Country Position/Affiliation
Brussels Belgium PI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will consist of sociodemographic, clinical and immunological data collected at all study timepoints. Study Protocol De-identified IPD will be available after final data collection and cleaning, and once laboratory quality control procedures have been conducted. Any interested party may request access to the data for the purposes of secondary analysis or meta-analysis. The process for requesting data, and the criteria upon which requests will be judged are described in Epicentre Standard Operating Procedures.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information