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.: PACTR202105585438650 Date of Approval: 05/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized controlled factorial trial to assess the effect of diet and health check-up alone, or combined with the state of the innate immune activation prior to vaccination and innate immune sensing of vaccine components, on the initialization and fine-tuning of adaptive immune responses to two live attenuated viral vaccines
Official scientific title A randomized controlled factorial trial to assess the effect of diet and health check-up alone, or combined with the state of the innate immune activation prior to vaccination and innate immune sensing of vaccine components, on the initialization and fine-tuning of adaptive immune responses to two live attenuated viral vaccines
Brief summary describing the background and objectives of the trial In our sub-Saharan African context, scarcity is a frequent socioeconomic condition. Scarcity determines consumption which comprises both diet and environmental living conditions (housing). Environmental living conditions determine exposure to pathogens. The type of diet and the repeated exposure to pathogens are underlying factors that induce and contribute to maintaining activated immune systems among sub-Saharan Africans. To test this hypothesis, we will modify the diet of research participants whilst ensuring a "sufficient and equilibrate" diet and identify and reduce/eliminate the effects of any pathogen on their immune system. We have designed this study to test the causality of diet and exposure to pathogens in inducing and maintaining states of persistent immune activation and therefore the causality of both diet and exposure to pathogens to induce altered vaccine-induced immune responses. We will perform this causality study in childhood where the type of diet has essential effects on the gut microbiome composition, and the exposure of the immune system to pathogens is the most intense. The impact of vaccines as a public health tool is considerable in children, who also serve as the essential reservoir of infectious diseases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FEVER OR MONEY
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 14/03/2021
Actual trial start date 01/03/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 346
Actual target sample size (number of participants) 346
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Balance diet A single dose of rVSVΔG-ZEBOV-GP vaccine (ERVEBO) The primary objective of this factorial clinical trial is 21 days after enrolment. The secondary and exploratory objectives have the same duration as the paediatric Ebola vaccine clinical trial with an estimated duration from November 2020 to December 2021. Also some of the participants will last for 21 days and others about a year in the study. This ancillary study will enroll a total number of 60 children of two age groups (6 to 12 years old and 1 to 5 years old) of the main phase 1/2 randomized controlled open label trial to assess the safety and immunogenicity of rVSV-ΔG-ZEBOV-GP Ebola vaccine. From the two equal age groups, children will be randomly assigned to 4 study causal groups. The causal groups are: "sufficient and equilibrate diet", "reduce/suppress effects of pathogens on the immune system", "sufficient and equilibrate diet" and "reduce/suppress effects of pathogens on the immune system", control. We will use the modalities of factorial design to randomize the participant to the four groups. Further, we will vaccinate children from the 4 causal groups with a live attenuated viral vaccine and therefore test the causal effect of diet and exposure to pathogens on the induction of altered vaccine-induced responses. 173
Control Group Reduce effect A single dose of varicella vaccine (VARILRIX) The primary objective of this factorial clinical trial is 21 days after enrolment. The secondary and exploratory objectives have the same duration as the paediatric Ebola vaccine clinical trial with an estimated duration from November 2020 to December 2021. Also some of the participants will last for 21 days and others about a year in the study. This ancillary study will enroll a total number of 60 children of two age groups (6 to 12 years old and 1 to 5 years old) of the main phase 1/2 randomized controlled open label trial to assess the safety and immunogenicity of rVSV-ΔG-ZEBOV-GP Ebola vaccine. From the two equal age groups, children will be randomly assigned to 4 study causal groups. The causal groups are: "sufficient and equilibrate diet", "reduce/suppress effects of pathogens on the immune system", "sufficient and equilibrate diet" and "reduce/suppress effects of pathogens on the immune system", control. We will use the modalities of factorial design to randomize the participant to the four groups. Further, we will vaccinate children from the 4 causal groups with a live attenuated viral vaccine and therefore test the causal effect of diet and exposure to pathogens on the induction of altered vaccine-induced responses. 173 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion and exclusion criteria are those of the clinical trial. In addition parents/guardians of the participants must express their willingness to enroll their children in this ancillary study and sign its specific informed consent. Mainly: • Be 1 to 12 years old • Apparent good health • Be part of candidate households for the Ebola vaccine clinical trial • Parents and/or guardians aged 21 or over who wish to have the child participate The volunteer will not enter the study if any of the following apply: • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions, or known allergy to the components of the vaccines. • Ongoing participation in another clinical trial • Participation in previous Ebola vaccine trials • Receipt of a licensed vaccine within 14 days of planned study immunization (30 days for live vaccines) • Presence of any febrile illness (fever >38°C) or any moderate to severe illness within one week prior to vaccination; • Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period • Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 1 Year(s) 12 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 15/12/2020 Comite Ethique Institutionnel
Ethics Committee Address
Street address City Postal code Country
rue Schweitzer Lambaréné 242 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - To quantify zymosan particles within neutrophils and macrophages day-14, day-7, day-1, day1, day7, day14, day28.
Secondary Outcome • To identify and quantify peptidoglycan from the microbiota in peripheral blood ( serum or plasma) at day-14, day-7, day-1, day1, day7, day14, day28 • To quantify the cytokine secretions at day-14, day-7, day-1, day1, day7, day14, day28, day 56, day 84. • To quantify serum triglyceride, hemoglobin A1c (HbA1c) and C-reactive protein at day-14, day-7, day7, day14, day28 • To categorise the levels of scarcity among the households involved in the study according to a consumption household survey performed day-14 and day 28 and/ Months 6 and month 12 day-14, day-7, day-1, day1, day7, day14, day28, day 56, day 84.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherches Medicales de Lambarene Quartier Schweitzer Lambarene 00242 Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
VARSAF EDCTP project Anna van Saksenlaan 51 2593 HW The Hague, The Netherlands The Hague 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre de Recherches Medicales de Lambarene Quartier Schweitzer Lambarene 00242 Gabon Institutional
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Selidji Todagbe AGNANDJI agnandjis@cermel.org +24177353114 Quartier Schweitzer
City Postal code Country Position/Affiliation
Lambarene 00242 Gabon Principal Investigator
Role Name Email Phone Street address
Public Enquiries Selidji Todagbe AGNANDJI agnandjis@cermel.org 0024177353114 Quartier Schweitzer
City Postal code Country Position/Affiliation
Lambarene 00242 Gabon Scientist
Role Name Email Phone Street address
Scientific Enquiries Selidji Todagbe AGNANDJI agnandjis@cermel.org 0024177353114 Quartier Schweitzer
City Postal code Country Position/Affiliation
Lambarene 00242 Gabon Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Source data and documents will be kept at the CERMEL. Data will be kept confidential. However, source data will be accessible for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s) purposes. Data will be entered into an electronic data base. Electronic data will be shared with partners’ scientists and institutions upon maintenance of confidentiality. Personal information, such as subject telephone no. and other individual identifying data, would be only collected on the log-books and these study documents will be kept with limited access (restricted to study personnel) in order to safeguard the privacy of the study participants and their confidentiality. All study documents and data, both computerized and hard-copy, will be securely maintained in locked place to minimize the risk to subjects of a breach of privacy/confidentiality. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The site owns the data and it is agreed that these will be shared or publication in a timely manner during the 15 years all biological material will be stored securely at CERMEL . No information concerning the study or the data will be released to any unauthorized third party, without prior written approval of the trial sponsor
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