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.: PACTR201905827924069 Date of Approval: 28/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN Filo in Infants
Official scientific title The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination Dose 1) and MVA-BN-Filo (second vaccination Dose 2) administered intramuscularly (IM) on Days 1 and 57 respectively.
Brief summary describing the background and objectives of the trial The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively.
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 Ebola
Purpose of the trial Prevention
Anticipated trial start date 12/07/2019
Actual trial start date 19/08/2019
Anticipated date of last follow up 22/09/2022
Actual Last follow-up date 08/11/2022
Anticipated target sample size (number of participants) 107
Actual target sample size (number of participants) 108
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 Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Parallel Assignment Participants will be administered 0.5 mL of Ad26.ZEBOV vaccine (5x1010 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of MVA-BN-Filo (1x108 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit. up to 12 months Participants will be administered 0.5 mL of Ad26.ZEBOV vaccine (5x1010 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of MVA-BN-Filo (1x108 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit. 72
Control Group Parallel Assignment Participants will be administered 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit. up to 12 months Participants will be administered 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit. 36 Active-Treatment of Control Group
Experimental Group Vaccination of control arm Participants will be administered 0.5 mL of Ad26.ZEBOV vaccine (5x1010 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of MVA-BN-Filo (1x108 infectious units [Inf U]) vaccine by IM injection on Day 57 up to 57 days and follow-up up to 85 days Preventative VAC52150 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria: - Parent(s) (preferably both if available or as per local requirements)/guardian must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study, and potential risks and benefits of the study, and are willing to allow their child to participate in the study - Parent(s)/guardian are willing/able to ensure that their child adheres to the prohibitions and restrictions - The parent(s)/guardian must be at or above the age of legal consent in the jurisdiction in which the study is taking place - Infant must be healthy in the investigator’s clinical judgment (and the parent(s)/guardian) on the basis of medical history, physical examination, vital signs and clinical laboratory tests performed at screening - Infant has received all routine immunizations appropriate for his or her age at the time of enrollment as documented in the vaccination cards presented by the parent(s)/guardian. Participants are allowed to catch up on routine immunizations if needed (support for beneficial vaccines may be offered to participants) Exclusion Criteria: - Having received any candidate or other Ebola vaccine - History of Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with a current Ebola outbreak less than 1 month prior to screening - Having received any experimental candidate Ad26- or modified vaccinia ankara (MVA)-based vaccine in the past - Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines [for example, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for Ad26.ZEBOV vaccine; and tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine]), including known allergy to egg, egg products and aminoglycosides - Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=)38.0 degree celsius on Day 1. Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date Infant: 13 Month(s)-24 Month(s) 4 Month(s) 11 Month(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 30/04/2019 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
5th Floor, Youyi Building Brookfields, Freetown Freetown 00232 Sierra Leone
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 18/06/2019 Comite National DEthique Pour la Recherche en Sante CNERS
Ethics Committee Address
Street address City Postal code Country
Conakry Conakry 2649 Guinea
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Following local AEs: pain, erythema, and induration at the study vaccine injection site, and systemic AEs: loss of appetite, vomiting, diarrhea, decreased activity, irritability will be noted in the participant diary for 7 days. The extent (largest diameter) of any redness or induration will be measured daily and recorded, along with any functional limitation of activity. 7 days post dose 1
Primary Outcome Following local AEs: pain, erythema, and induration at the study vaccine injection site, will be noted in the participant diary for 7 days. The extent (largest diameter) of any redness or induration will be measured daily and recorded, along with any functional limitation of activity. 7 days post-dose 2
Primary Outcome Percentage of participants with unsolicited AEs will be evaluated. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary. up to 28 days post-dose 1
Primary Outcome An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is lifethreatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Up to 28 days post-dose 2
Secondary Outcome Serum samples will be collected for analysis of binding antibodies against EBOV GP using filovirus animal nonclinical group enzymelinked immunosorbent assay (FANG ELISA), to determine humoral responses following vaccination. At 21 days post-dose 2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
College if Med and Allied Health Sciences University Magbema Street, Kambia Town, Kambia District Northern Province Sierra Leone Kambia 0232 Sierra Leone
Centre National de Formation et de Recherche en Sante Rurale Maferenya , Conakry Conakry 2649 Guinea
FUNDING SOURCES
Name of source Street address City Postal code Country
Janssen Vaccines and Preventions B.V. Archimedesweg, 29 Leiden 2333 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Janssen Vaccines and Preventions B.V. Archimedesweg, 29 Leiden 2333 Netherlands Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Institut National de la Sante et de la Recherche Medicale INSERM U1219 Universite de Bordeaux ISPED, 146, rue Leo Saignat CS1292 Bodeaux 33076 France
London School of Hygene and Tropical Medicine LSHTM Keppel St, London WC1E 7HT London United Kingdom
College of Medicine and Allied Health Sciences COMAHS 12 Victoria Street,kossoh town, Freetown, Sierra Leone Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bailah Leigh bailahleigh@yahoo.co.uk +23276693102 University of Sierra Leone, FBC Campus
City Postal code Country Position/Affiliation
Freetown 00232 Sierra Leone PI
Role Name Email Phone Street address
Scientific Enquiries Deborah Watson Jones Deborah.Watson-Jones@lshtm.ac.uk +442076368636 Keppel St, Bloomsbury
City Postal code Country Position/Affiliation
London United Kingdom Chief Investigator
Role Name Email Phone Street address
Public Enquiries Edward Choi Edward.Choi@lshtm.ac.uk +442076368636 Keppel St, Bloombury
City Postal code Country Position/Affiliation
London United Kingdom Public Enquiries
Role Name Email Phone Street address
Principal Investigator Abdoul Habib Beavogui beavoguia_h@yahoo.com +224625258455 Maferenya , Conakry, Conakry, 2649, Guinea
City Postal code Country Position/Affiliation
Conakry 2649 Guinea Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be shared on due time Study Protocol IPD sharing Time Frame will be in 2 years. controlled individual.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://pam.sylogent.com/cr/CR108617 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