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.: PACTR202405738173023 Date of Approval: 03/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect Of Rural-Urban Settings And Parasitic Infections On The Immune System And Vaccination Responses: A Study In Kilimanjaro And Arusha Regions In Tanzania
Official scientific title Effect Of Rural-Urban Settings And Parasitic Infections On The Immune System And Vaccination Responses: A Study In Kilimanjaro And Arusha Regions In Tanzania
Brief summary describing the background and objectives of the trial The invention of vaccines and other immunological therapeutics marks significant medical science and care milestones. However, it has been shown that there is considerable variation in vaccine efficacy attributed to geographical differences. It has become clear that many vaccines have reduced effectiveness in some geographical regions, especially the low- and middle-income countries (LMICs) or rural settings compared to urban environments. For example, whereas the efficacy and immunogenicity of BCG, rotavirus and malaria vaccines are high in high-income countries, they are less immunogenic and efficacious in LMICs. Despite the frequent reporting of this discrepancy, there has been little research into the mechanisms underlying the variation in vaccine efficacy between geographical areas. Therefore, the current proposal aims to understand vaccine variation mechanisms in designing strategies to improve vaccine efficacy in areas where vaccines are needed the most. Objectives: To determine the effect of rural-urban setting and exposures to microorganisms and parasites on the immune system and vaccine responses in Arusha and Kilimanjaro regions Tanzania.
Type of trial Non-Randomised
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 Studying immune system variation and variation in vaccine response using yellow fever vaccine.
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 03/08/2022
Actual trial start date 01/09/2022
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date 30/09/2023
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 180
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
4089 National Institute For Medical Research
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Yellow fever vaccine 0.5 ml of yellow fever vaccine was given once. Yellow fever vaccine was given once and we followed individuals for six months, where we collected blood sample, urine and stool sample. Blood sample continuously for PBMC isolation and storage of plasma and serum. We collected stool samples for microbiome study, linking microbiome and vaccine response, and at the same time stool was used for screening soil transmitted infection. Urine sample was for screening schistosomiasis but also studying metabolites and studying if we can detect antibodies in urine. We first did pilot study where we included four sites this formed the basis of two selected sites which were involved in yellow fever vaccine study. For the longitudinal part of the study we recruited 180 young adults 15 from rural and 15 from urban who were selected as controls and 75 from rural and 75 from urban were vaccinated with 0.5ml of yellow fever vaccine. Volunteers received a single dose of yellow fever vaccination, and samples were collected at baseline and after vaccination at days 0, 2, 7, 14, 28, 56, 178 after vaccination. Samples to be collected include urine, stool and peripheral blood samples. 180
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. People who are permanent residents of the selected areas and expected to stay during the whole duration of the study 2. Aged 18-35 years 3. Accepted written consent 1. Clinically significant history of diseases like HIV, TB, Cancer, Cardiovascular diseases, gastrointestinal disease, liver disease, renal disease, an endocrine disorder, or neurological illness. 2. History of recurrent infections and being admitted 2 or more times a year at hospital and receiving antibiotics as it will be shown in discharge summary. 3. History of long-term use of corticosteroids for any reasons, i.e. concurrent oral or systemic steroids medication or the concurrent use of other immunosuppressive agents within 2 to 3 months before enrolment. 4. Hospital admission in the past 3 months 5. Any history of being the recipient of vaccines that will be used during the study 6. Positive HIV serology 7. Haemoglobin levels less than 8.5 g/dl 8. A positive pregnancy test at the start or during the study 9. History of nose bleeding 10. Female currently lactating 11. Transfusion of blood products within three months before the study 12. Received immunoglobulins within three months before the study 13. Low blood pressure ≤90/60 mm Hg 14. High blood glucose >7.1 mmol l−1 fastings or  >11.1 mmol l−1 random RBG Adult: 19 Year-44 Year 18 Year(s) 35 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 03/08/2022 Tanzania National Ethical Committee Board
Ethics Committee Address
Street address City Postal code Country
3 Baraka Obama Drive Dar es Salaam 15115 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immune Response antibody titers and cellular response memory T and B cells 0,2,7,14,28,56,90, 178 days
Secondary Outcome Safety and side effects. 0,2,7,14,28,56,90,178 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Christian Medical Centre KCMC However field team went to respective study sites and collected sample thereafter sample processed at KCMC. KCMC P.O.BOX 3010 MOSHI 25116 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Dutch Research Organization and European Research Council Albinusdreef 2 Leiden 2333 ZA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kilimanjaro Christian Medical Centre KCMC KCMC Moshi 25116 Tanzania Hospital
COLLABORATORS
Name Street address City Postal code Country
Maria Yazdanbakhsh Post office box 9600 Leiden 2333 ZA Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Jeremia Pyuza pyuzaraymond@gmail.com +255783152962 KCMC
City Postal code Country Position/Affiliation
Moshi 25116 Tanzania KCMC
Role Name Email Phone Street address
Principal Investigator Maria Yazdanbakhsh m.yazdanbakhsh@lumc.nl +31715265067 Albinusdreef 2
City Postal code Country Position/Affiliation
Leiden 2333 ZA Netherlands LUMC
Role Name Email Phone Street address
Public Enquiries Marloes van Dorst M.M.A.R.van_Dorst@lumc.nl +31683800677 Albinusdreef 2
City Postal code Country Position/Affiliation
Leiden 2333 ZA Netherlands LUMC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are now doing data cleaning, laboratory experiments and we will share data soon as we have results available starting with pilot study results, where we compare the immunological difference between rural and urban settings. Informed Consent Form,Study Protocol After six months, After publications of results data of respective study will be available in the link which will be provided, if there is need for additional information and individual can request for that.
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