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.: PACTR201504001092179 Date of Registration: 01/04/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 202091 (EBOLA Z CHAD3-005)
Official scientific title 202091 (EBOLA Z CHAD3-005)
Brief summary describing the background and objectives of the trial On 7 August 2014, the World Health Organisation (WHO) requested that GlaxoSmithKline (GSK) ¿fully engages in WHO-coordinated efforts to test, license and make available safe and effective Ebola interventions¿ to assist in the control of the outbreak in Western Africa. Given the severity of the situation, time to vaccine deployment was an important aspect of the WHO request. In response to this call, an accelerated Phase 1, dose-finding vaccine development effort was initiated mid-August that involved WHO, GSK, Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (VRC/NIAID), the University of Oxford, the University of Maryland and the University of Lausanne and the Centre for Vaccine Development in Mali. Primary ¿ To assess the safety and reactogenicity of a single IM dose of the ChAd3-EBO-Z vaccine. Secondary ¿ To assess the humoral immunogenicity of a single IM dose of the ChAd3-EBO-Z vaccine, in terms of anti-glycoprotein (GP) EBOV antibody responses.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied EBOLA,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/05/2015
Actual trial start date
Anticipated date of last follow up 30/10/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 3000
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised The randomisation will use a minimisation procedure accounting for age (18 - 40 years, 41 to 60 years or >60 years), gender and centre Central Randomization Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised The randomisation will use a minimisation procedure accounting for age (18 - 40 years, 41 to 60 years or >60 years), gender and centre Central Randomization 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 ChAd3-EBO 1-2 ml once only Once only Vaccination and Placebo 1500 Placebo
Experimental Group ChAd3-EBO-Z 1-2mL - once or twice Once EBOLA ChAd3-EBO-Z vaccine 1500 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All subjects must satisfy ALL the following criteria at study entry: ¿ Subjects who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g. capability of or availability for Diary Card completion, return for follow-up visits, availability for clinical follow-up throughout the study period). ¿ Written/ thumb printed informed consent obtained from the subject prior to performing any study specific procedure or written/ thumb printed informed consent obtained from the subject¿s parent(s)/ legally acceptable representative(s) (LAR[s]) and written/ thumb printed informed assent obtained from the subject, for minor subjects. This will only be applicable for countries where the legal age of majority is ¿ 21 years. (Amended 17 February 2015.) ¿ A male or female aged 18 years of age or older at the time of Screening. (Amended 17 February 2015.) ¿ Healthy subjects as per Investigator judgement, as established by medical history, clinical examination and haematology/ biochemistry laboratory parameters screening before entering into the study. ¿ Female subjects of non-childbearing potential may be enrolled in the study. ¿ Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. Please refer to the glossary of terms for the definition of menarche and menopause. ¿ Female subjects of childbearing potential may be enrolled in the study, if the subject: ¿ has practiced adequate contraception for 30 days prior to the Day 0 visit, and ¿ has a negative pregnancy test at the Day 0 visit, and ¿ has agreed to continue adequate contraception until 30 days after the Month 6 visit. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period. ¿ Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chimpanzee adenoviral vectored investigational vaccine. ¿ Known prior EBOV or SUDV disease. ¿ Travel to a country affected by the EBOV epidemic or direct contact with a person with EVD within 21 days prior to the Day 0 visit. ¿ History of any reaction or hypersensitivity (such as anaphylaxis, urticaria [hives], respiratory difficulty, angioedema, or abdominal pain) likely to be exacerbated by any component of the study vaccine. ¿ Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit. ¿ Serious acute or chronic illness determined by medical history and clinical examination including, but not limited to: ¿ Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome [AIDS]). ¿ Any clinically significant haematological (CBC, including differential count and platelet count) or biochemical (ALT, creatinine) laboratory abnormality. Refer to APPENDIX C for acceptable limits for eligibility determination. ¿ Any chronic illness with recent signs of exacerbation, or imposing a change in the chronic treatment regimen, within 3 months prior to the Day 0 visit. ¿ Any unstable chronic medical condition (e.g. uncontrolled asthma). ¿ Pregnant female. 18 Year(s) 999 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 13/03/2015 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health, Federal Secretariat Complex, Shehu Shagari Way Garki-Abuja PMB083 Nigeria
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 13/03/2015 Faculty of Medicine & Odontostomatology
Ethics Committee Address
Street address City Postal code Country
BP1805, Bamako, Mali Bamako BP 1805 Mali
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 13/03/2015 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Local IRB, University of Ghana, Legon Accra Ghana
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 13/03/2015 Kintampo Health Research Centre
Ethics Committee Address
Street address City Postal code Country
Kintampo North Municipality, PO Box 200 Brong Ahafo Region Ghana
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 13/03/2015 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Local IRB, University of Ghana, Legon Accra Ghana
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 13/03/2015 Kintampo Health Research Centre
Ethics Committee Address
Street address City Postal code Country
Kintampo North Municipality, PO Box 200 Brong Ahafo Region Ghana
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 13/03/2015 Comité National d'Ethique de la Recherche pour la Santé Humaine
Ethics Committee Address
Street address City Postal code Country
Quartier Messa (enceinte Hygyène Mobile), Minstère de la Santé Publique Yaoundé Cameroon
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 13/03/2015 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Local IRB, University of Ghana, Legon Accra Ghana
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 13/03/2015 Kintampo Health Research Centre
Ethics Committee Address
Street address City Postal code Country
Kintampo North Municipality, PO Box 200 Brong Ahafo Region Ghana
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 13/03/2015 Comité National d'Ethique de la Recherche pour la Santé Humaine
Ethics Committee Address
Street address City Postal code Country
Quartier Messa (enceinte Hygyène Mobile), Minstère de la Santé Publique Yaoundé Cameroon
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 13/03/2015 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Local IRB, University of Ghana, Legon Accra Ghana
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 13/03/2015 Kintampo Health Research Centre
Ethics Committee Address
Street address City Postal code Country
Kintampo North Municipality, PO Box 200 Brong Ahafo Region Ghana
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 13/03/2015 Comité National d'Ethique de la Recherche pour la Santé Humaine
Ethics Committee Address
Street address City Postal code Country
Quartier Messa (enceinte Hygyène Mobile), Minstère de la Santé Publique Yaoundé Cameroon
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 13/03/2015 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Local IRB, University of Ghana, Legon Accra Ghana
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 13/03/2015 Kintampo Health Research Centre
Ethics Committee Address
Street address City Postal code Country
Kintampo North Municipality, PO Box 200 Brong Ahafo Region Ghana
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 13/03/2015 Comité National d'Ethique de la Recherche pour la Santé Humaine
Ethics Committee Address
Street address City Postal code Country
Quartier Messa (enceinte Hygyène Mobile), Minstère de la Santé Publique Yaoundé Cameroon
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 13/03/2015 Coordonnateur du Comité National d'Ethique de la Recherche en Santé (CNERS)
Ethics Committee Address
Street address City Postal code Country
Ministère de la Snté et de l'action Sociale, Fann Résidence, Rue Aimé Césaire, 2ème étage Dakar B.P 4024 Senegal
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 13/03/2015 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Local IRB, University of Ghana, Legon Accra Ghana
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 13/03/2015 Kintampo Health Research Centre
Ethics Committee Address
Street address City Postal code Country
Kintampo North Municipality, PO Box 200 Brong Ahafo Region Ghana
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 13/03/2015 Comité National d'Ethique de la Recherche pour la Santé Humaine
Ethics Committee Address
Street address City Postal code Country
Quartier Messa (enceinte Hygyène Mobile), Minstère de la Santé Publique Yaoundé Cameroon
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 13/03/2015 Coordonnateur du Comité National d'Ethique de la Recherche en Santé (CNERS)
Ethics Committee Address
Street address City Postal code Country
Ministère de la Snté et de l'action Sociale, Fann Résidence, Rue Aimé Césaire, 2ème étage Dakar B.P 4024 Senegal
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 13/03/2015 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Local IRB, University of Ghana, Legon Accra Ghana
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 13/03/2015 Kintampo Health Research Centre
Ethics Committee Address
Street address City Postal code Country
Kintampo North Municipality, PO Box 200 Brong Ahafo Region Ghana
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 13/03/2015 Comité National d'Ethique de la Recherche pour la Santé Humaine
Ethics Committee Address
Street address City Postal code Country
Quartier Messa (enceinte Hygyène Mobile), Minstère de la Santé Publique Yaoundé Cameroon
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 13/03/2015 Coordonnateur du Comité National d'Ethique de la Recherche en Santé (CNERS)
Ethics Committee Address
Street address City Postal code Country
Ministère de la Snté et de l'action Sociale, Fann Résidence, Rue Aimé Césaire, 2ème étage Dakar B.P 4024 Senegal
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 13/03/2015 NAFDAC
Ethics Committee Address
Street address City Postal code Country
3/4, Apap-Oshodi Expressway, Oshodi Lagos Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of each solicited local and general AE during a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days), in a sub-co-hort of 750 subjects per group
Primary Outcome Occurrence of any unsolicited local and general AE - during a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days), in a sub-cohort of 750 subjects per group.
Primary Outcome Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatine) laboratory abnormalities in a sub-cohort group at Screening, Day 3, Day 6, Day 30, Month 6 and Month 12 in a sub-cohort of 750 subjects per group, and at Month 6 + 6 days and Month 6 + 30 days
Primary Outcome Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest) during a 7-day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6)
Primary Outcome Occurrence of any SAE, in all subjects, in both groups Throughout participation
Secondary Outcome Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay At Day 0 and Day 30, in a sub-cohort of 750 subjects per group. ¿ At Month 6 and Month 6 + 30 days, in a sub-cohort of 750 subjects in the Group Placebo/ EBO-Z.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hohoe Health Research Centre University of Health and Allied Sciences Research Centre, School of Public Health, Hohoe Municpal Hospital Hohoe Ghana
Malaria Reseazrch & Training Center Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology Bamako BP 1805 Point G Mali
Center for Vaccine Development - Mali (CVD Mali) CNAM Centre National d'Appui a la Lutte Contre la Maladie, Ex-Institut Marchoux Bamako BP 251 Mali
Walter Reed Program Nigeria Clinical Research Clinical Research Centre, 7 Usuma Street Abuja Nigeria
Jos University Teaching Hospital Vom Christian Hospital (VCH), Vom Jos South Nigeria
Hospital Aristide le Dantec Laboratoire Bactériologie Virologie, CHU Le Dantec, Avenue Pasteur Dakar B.P : 3725 Senegal
Clinique des maladies Infectieuses Ibrahima-Diop-Mar Centre Hospitalier National Universitaire de Fann, Clinique des Maladies Infectieuses Ibrahima Dop Mar, Avenue Cheikh Anta Diop Dakar-Fann BP 5035 Senegal
Centre Pasteur du Cameroun Rue Henri Dunant Yaounde BP1274 Cameroon
Tuberculosis Reference Laboratory - Bamenda c/o North West Special Fund for Health Promotion Bamenda Cameroon
Centre Pasteur du Cameroun Rue Henri Dunant Yaoundé BP1274 Cameroon
Kintmpo Health Centre (KHRC) Ministry of Health, No2 Health Loop, Kintampo North Municipality Brong Ahafo Region Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
GlaxoSmithKline (GSK) Rue de I'institut 89 Rixensart 1330 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor GlaxosSmithKline (GSK) Rue de I'institut 89 Rixensart 1330 Belgium Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Quintiles Transnational 1011 Pretorius Avenue South Lyttleton, Centurion 0157 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Sue Bailey sue.bailey@quintiles.com +27126712330 1011 Pretorius Ave South, Lyttleton
City Postal code Country Position/Affiliation
Centurion 0157 South Africa Director, CLinical Operations
Role Name Email Phone Street address
Scientific Enquiries Guy Vernet vernet@pasteur-yaounde.org +237 699 31 33 62 Centre Oasteur du Cameroun, Rue Henry Dunant BP1274,
City Postal code Country Position/Affiliation
Yaounde Cameroon Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Seydou Doumbia mdiakite65@yahoo.com (+223)7646-1339 Faculty of Medicine and Odontostomatology (FMOS)
City Postal code Country Position/Affiliation
Bamako Bp 1805 Mali Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Samba Sow ssow@medicine.umaryland.edu +223 20 23 60 31 Centre National d¿Appui à la lutte contre la Maladie (CNAM), Ministere de la Santé et de l'Hygiene Publique, Ex Institut Marchoux
City Postal code Country Position/Affiliation
Bamako 251 Mali Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Kinge Thompson Kinge_TN@yahoo.com +237 677 623 606 Bamenda Regional Hospital, Bamenda
City Postal code Country Position/Affiliation
North West Region Cameroon Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Souleymann Mboup virus@orange.sn +221 33 822 59 19 Laboratoire Bacteriologie et Virologie, Address: 30, Avenue Pasteur-Hopital Aristide Le Dantec
City Postal code Country Position/Affiliation
Dakar 7325 Senegal Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Cheikh Ndour elhaji3@yahoo.com (221) 773397460 Clinique des Maladies Infectieuses Ibrahima Diop Mar, Centre Hospitalier Universitaire de Fann,enue Cheikh Anta Diop
City Postal code Country Position/Affiliation
Dakar Senegal Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Keshinro Babajide aakintunde@wrp-n.org 2347034181221 Walter Reed Program Nigeria, Clinical Research Center, 7 Usama Street, Off Gana Street
City Postal code Country Position/Affiliation
Maitama, Abuja, FCT 90271 Nigeria Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Oguche Stephen soguche2001@yahoo.com 2348101646884 Jos University Teaching Hospital/APIN, Murtala Muhammed Road, Old JUTH Campus, Jos
City Postal code Country Position/Affiliation
Plateau 930001 Nigeria Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Kwaku Poku Asante kwakupoku.asante@kintampo-hrc.org +233208956598 Kintampo Health Research Centre,Ministry of Health, No.2 Health loop, Kintampo North Municipality
City Postal code Country Position/Affiliation
Brong Ahafo Region Ghana Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Kwadwo Ansah Koram kkoram@noguchi.ug.edu.gh +233 204 313130 Noguchi Memorial Institute for Medical Research, University of Ghana
City Postal code Country Position/Affiliation
Legon Box LG 581 Ghana Principal Investigator
REPORTING
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