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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201507001154522 Date of Registration: 01/06/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 202090 (EBOLA Z CHAD3-004)
Official scientific title 202090 (EBOLA Z CHAD3-004)
Brief summary describing the background and objectives of the trial On 7 August 2014, the WHO requested that 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, VRC/NIAID, the University of Oxford, the University of Maryland and the University of Lausanne and the Centre for Vaccine Development in Mali. Although health care workers will be priority vaccination targets, mass vaccination strategies may be developed as one of the ways to protect populations and contain the epidemics. In this context, children will need to be vaccinated too. The present Phase 2, randomised, controlled trial will aim at collecting safety and immunogenicity data following a single intramuscular (IM) dose of the investigational ChAd3 EBO-Z vaccine. The study will be conducted in healthy children living in countries adjacent to the current Ebola outbreak zones. In parallel with the current study, the safety and immunogenicity of the investigational ChAd3-EBO-Z vaccine will be assessed in healthy adults living in countries adjacent to the current Ebola outbreak (study EBOLA Z CHAD3-005). Study EBOLA Z CHAD3-005 will start before the current study as to collect safety and reactogenicity data in 100 adults, after 1 week of follow-up, living in countries adjacent to the current Ebola outbreak before proceeding to vaccination of children.
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
Anticipated trial start date 15/08/2015
Actual trial start date
Anticipated date of last follow up 07/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 300
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 Subjects will be randomised (1:1) at Day 0. In order to ensure equal distribution of the population, enrolment will be stratified by age so that an equal number of children are enrolled in each age stratum (1 to 5 years, 6 to 12 years, and 13 to 17 years of age). In addition, the randomisation will use a minimisation procedure accounting for gender and centre Observer blind from study start to interim analysis. Single blind as interim analysis at Day 30 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ebola/Nimenrix Dose for Nimenrix is 0.5mL, dose for Ebola is 1 mL. 12 Months Participant will receive Ebola vaccine at Day 0 and Nimerix at M6. Safety assessments and samples to test for Humoral Immunity and Cell Mediated Immunity will be collected at certain visits. In addition diary card will be completed to document any AE¿s and physical examination including vital signs will be performed at certain visits. 300 Active-Treatment of Control Group
Control Group Nimenrix/Ebola Dose for Nimenrix is 0.5mL, dose for Ebola is 1 mL. 12 months Participant will receive Nimenrix vaccine at Day 0 and Ebola vaccine at M6. Safety assessments and samples to test for Humoral Immunity and Cell mediated immunity will be collected at certain visits. In addition diary card will be completed to document any AEs and physical examination including vital signs will be performed at certain visits. 300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects parent(s)/ legally acceptable representative(s) (LAR[s]) who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., 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¿ parent(s)/ LAR(s) prior to performing any study specific procedure. In addition, written/ thumb printed informed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements). ¿A male or female child aged 1 to 17 years inclusive at the time of Screening. (Amended 06 May 2015.) ¿Subjects with a negative RDT test for Malaria within 30 days prior to randomisation into the study. OR Subjects with a positive RDT test for Malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study. (Amended 06 May 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 or ovariectomy. Please refer to the glossary of terms for the definition of menarche. ¿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. Please refer to the glossary of terms for the definition of adequate contraception Child in care. Please refer to the glossary of terms for the definition of child in care. (Amended 06 May 2015.) ¿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 country affected by the EBOV epidemic or direct contact with 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. ¿Acute or chronic illness determined by medical history, clinical examination and laboratory screening tests including, but not limited to: Clinically significant immunosuppressive or immunodeficient condition (e.g., clinical acquired immune deficiency syndrome [AIDS]). Major congenital defects. Malnutrition (defined as weight for age Z-score less than -3, or other clinical signs of malnutrition). Any clinically significant haematological or biochemical laboratory abnormality (see APPENDIX C for acceptable limits for eligibility determination). ¿Pregnant female. ¿Any condition that in the Investigator¿s opinion may potentially compromise subject safety or interfere with subject assessment or compliance. (Amended 06 May 2015.) 1 Year(s) 17 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 15/06/2015 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 15/06/2015 Comite' National d'Ethique de la Recherche pour la Sante' Humaine
Ethics Committee Address
Street address City Postal code Country
Quartier Messa (enceinte Hygyene Mobile), Minstere de la Sante' Publique Yaounde 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 15/06/2015 NAFDAC
Ethics Committee Address
Street address City Postal code Country
3/4, Apap-Oshodi Expressway, Oshodi Lagos 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 15/06/2015 Coordonnateur du Comite' National d'Ethique de la Recherche en Sante (CNERS)
Ethics Committee Address
Street address City Postal code Country
Ministere de la Snte' et de l'action Sociale, Fann Residence, Rue Aime' Cesaire, 2eme etage Dakar BP4024 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 15/06/2015 Faculty of Medicine & Odontostomatology
Ethics Committee Address
Street address City Postal code Country
BP1805, Bamako, Mali Bamako BP 1805 Mali
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 in all subjects, in both groups.
Primary Outcome ¿Occurrence of any unsolicited AE During a 30-day follow-up period after each vaccination (i.e., the day of vaccination and 29 subsequent days), in all subjects, in both groups.
Primary Outcome ¿ Occurrence of haematological (CBC, including differential count and platelet count) and biochemical (ALT, creatinine) laboratory abnormalities At Screening, Day 3, Day 6, Day 30, Month 6, Month 6 + 6 days, Month 6 + 30 days and Month 12 in all subjects in both groups.
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), in all subjects, in both groups. (Amended 06 May 2015.)
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 (ELISA) At Day 0 and Day 30, in all subjects, in both groups. At Month 6 and Month 6 + 30 days, in all subjects, in the Group MENACWY TT/ EBO-Z.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kintampo Health Centre (KHRC) Ministry of Health, No2 Health Loop, Kintampo North Municipality Brong Ahafo Region Ghana
Jos University Teaching Hospital Vom Christian Hospital (VCH), Vom Jos South Nigeria
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
Center for Vaccine Development- Mali (CVD Mali) CNAM Centre National d'Appui a la Lutte Contre la Maladie, Ex-Institut Marchoux Bamako BP251 Mali
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
Principal Investigator Guy Vernet tejiokem@pasteur-yaounde.org +237 699 31 33 62 Centre Pasteur du Cameroun, Rue Henry Dunant
City Postal code Country Position/Affiliation
Yaounde BP1274 Cameroon Principal Investigator
Role Name Email Phone Street address
Principal Investigator Cheikh Ndour elhaji3@yahoo.com +221 773 397 460 Cliniques des Maladies Infectieuses Ibrahima Diop Mar, Centre Hospitalier Universitaire de Fann, Avenuw Cheikh Anta Diop
City Postal code Country Position/Affiliation
Dakar Senegal Principal Investigator
Role Name Email Phone Street address
Principal Investigator Stephen Oguche soguche2001@yahoo.com +234 810 164 884 Jos University Teaching Hospital/APIN, Murtala Muhammed Rd, Old JUTH Campus, Jos
City Postal code Country Position/Affiliation
Plateau 930001 Nigeria Principal Investigator
Role Name Email Phone Street address
Principal Investigator Kwaku Poku Asante kwakupoku.asante@kintampo-hrc.oeg +233 208956598 Kintampo Health Research Centre, Ministry of Heatlh, No2 Health Loop, Kintampo North Municipality
City Postal code Country Position/Affiliation
Brong Ahafo Region Ghana Principal Investigator
Role Name Email Phone Street address
Principal Investigator Samb Sow ssow@medicine.umaryland.edu +223 202 360 31 Centre National dAppui a la lutte contre la Maladie (CNAM), Ministere de la Sante et de l'Hygiene Publique, Ex Institute Machoux
City Postal code Country Position/Affiliation
Bamako BP251 Mali Principal Investigator
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 Patrice Golbert Patrice.Golbert@quintiles.com +33 140 215 998
City Postal code Country Position/Affiliation
Paris France Researcher
REPORTING
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Result URL Hyperlinks
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