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.: PACTR202011804563392 Date of Approval: 26/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA)
Official scientific title A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA)
Brief summary describing the background and objectives of the trial Typhoid fever remains a significant health problem in sub Saharan Africa with incidence rates > 100 cases per 100,000 person years of observation despite available typhoid conjugate vaccines (TCV). No cluster-randomized trial has been conducted on the African continent to our knowledge informing on TCV population-level protection data. A cluster-randomized controlled phase IV trial will assess the impact of a Vi-Polysaccharide conjugated Tetanus toxoid vaccine in the population of intervention clusters compared with the population in control clusters that are receiving a meningococcal A conjugate vaccine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TyVEGHA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Typhoid fever
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/03/2021
Actual trial start date
Anticipated date of last follow up 31/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 23000
Actual target sample size (number of participants)
Recruitment status Active, not 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 Simple randomization using a randomization table from a statistics book 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
Control Group MCVA single dose of 5 micrograms of Meningococcal A Conjugate vaccine n/a Meningococcal A Conjugate vaccine 11500 Active-Treatment of Control Group
Experimental Group ViTT Purified Vi-Capsular Polysaccharide of S. Typhi Ty2 conjugated to Tetanus Toxoid 25μg n/a Single-dose of Vi-TT in children 9 months to <16 years of age. 11500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Healthy participants aged 9 months to <16 years (i.e. ≤15 years and 364 days) of age at time of vaccination • Participants/Parents/legally authorised representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to <16 years)) and informed consent • Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study • Known allergy to any vaccine component • Self-reported ongoing acute and/or chronic illness • Any self-reported coagulopathies • Any medical or social compelling reasons in the judgment of a clinical physician • Self-reported pregnancy/Positive urine pregnancy test or lactating • Previous typhoid vaccination in the last 5 years (proven by presentation of a vaccine card or self-reporting). Temporary exclusion criteria • Self-reported fever (elevated tympanic (≥38°C) or axillary temperature (≥37.5°C)) within 24 hours of vaccination • Self-reported use of antipyretics within 4hours prior to vaccination • Any other vaccination during the last 4 weeks (proven by presentation of a vaccine card or self-reporting) • Girls ≥11 years of age with self-reported irregular menstruation or who do not know their last menstruation date Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 9 Month(s) 16 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
No 25/11/2020 International Vaccine Institute Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
SNU Research Park, 1 Gwanak-ro, Gwanak-gu Seoul 08826 Korea, Republic of
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incidence of blood culture-confirmed symptomatic TF in all vaccine recipients of the intervention clusters, compared with control clusters. up to 3 years after mass vaccination campaign
Secondary Outcome 1) Vi-TT vaccine safety in participants receiving Vi-TT compared with MCV-A, measured by: • The proportion of participants in each group of a sub-sample of the cohort developing local and/or systemic solicited adverse events/adverse reactions within the first 7 days post-vaccination. • The proportion of participants in each group of the cohort developing serious adverse events during the entire study period, as determined by self-reporting at follow-up contact. 2) The incidence of blood culture-confirmed symptomatic TF in all residents of the intervention clusters compared with that in all residents of control clusters 3.1) The incidence of severe TF in vaccinated individuals in intervention clusters compared to control clusters 3.2) The incidence of severe TF in all residents of the intervention clusters compared with that in all residents of control clusters 4.1) The incidence of clinical typhoid fever cases, defined as persistent fever (tympanic (≥38.0℃) or axillary temperature (≥37.5℃) or reported fever for ≥3 consecutive days) with abdominal complaints at a study surveillance site in vaccinated individuals in intervention clusters compared to control clusters. 4.2) The incidence of clinical typhoid fever cases presenting at a study surveillance site among all residents of the Vi-TT clusters compared to the control vaccine clusters. 5) The incidence of blood culture-confirmed symptomatic TF in non-vaccinees of the intervention clusters compared with control clusters. 6) The seroconversion rates and antibody concentration as measured by enzyme linked immunosorbent assay (anti-Vi IgM and IgG) for S. Typhi and iNTS at defined time points in a age-stratified subset of intervention and control vaccinees. up to 3 years after mass vaccination campaign
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Agogo KNUST IVI Collaborating Center Agogo Presbyterian Hospital Agogo Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership 2509 AA The Hague The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Vaccine Institute SNU Research Park, 1Gwanak-ro, Gwanak-gu Seoul 08826 Korea, Republic of Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
International Centre for Diarrhoeal Disease Research Bangladesh 68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka 1212, Bangladesh Dhaka Bangladesh
Kwame Nkrumah University of Science and Technology School of Public Health Kumasi Kumasi Ghana
University of Cambridge Trinity Lane, Cambridge Cambridge CB2 1TS United Kingdom
University of Maryland 685 W. Baltimore Street Baltimore MD 21201 United States of America
Fondation Merieux 17 rue Bourgelat Lyon 69002 France
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Andrea Haselbeck andrea.haselbeck@ivi.int +821040714764 SNU Research Park, 1 Gwanak-ro, Gwanak-gu
City Postal code Country Position/Affiliation
Seoul 08826 Korea, Republic of Senior Research Scientist
Role Name Email Phone Street address
Principal Investigator Florian Marks fmarks@ivi.int +821087033813 SNU Research Park, 1 Gwanak-ro, Gwanak-gu
City Postal code Country Position/Affiliation
Seoul Korea, Republic of Deputy Director General
Role Name Email Phone Street address
Public Enquiries Andrea Haselbeck andrea.haselbeck@ivi.int +821040714764 SNU Research Park, 1 Gwanak-ro, Gwanak-gu
City Postal code Country Position/Affiliation
Seoul Korea, Republic of Senior Research Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results will be posted within the trial registry within 12 months of completion. Study Protocol 12 months after study completion Controlled access will be provided based on individual requests and reviews.
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