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.: PACTR201509001259869 Date of Approval: 10/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Phase II Clinical Trial to Evaluate the Recombinant Human Type 5 Adenovirus Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV)
Official scientific title A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone
Brief summary describing the background and objectives of the trial Ebola viruses (EBOVs) are known to cause fatal hemorrhagic fever in humans and non-human primates with a mortality rate up to 90%. Among the five different species of EBOV been identified, the most infectious is Zaire and has caused greatest number of deaths including the current Ebola Virus Disease (EVD) outbreak in Sierra Leone and West African region. No specific curative medicine is yet available, therefore, vaccine trials are carried out globally to address prevention of another EVD outbreak of such magnitude. The Recombinant Human Type 5 Adenovirus Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) is a recombinant replication defective human recombinant Ad5 vector based vaccine expressing Ebola virus glycoprotein (Guinea, 2014). A phase I clinical trial evaluating safety, tolerability and immunogenicity of the Ad5-EBOV Vaccine was established with 120 Chines participants in Taizhou, Jiangsu Province in China, started Dec 28, 2014 (Trial no. NCT02326194). It evaluated safety from 0 to 28 days after injection of low dose 4×1010vp and high dose 1.6×1011vp Ad5-EBOV. Incidence of adverse reactions was quite similar with reports of other Ebola vaccines, good tolerance of the participants of the Ad5-EBOV was found. Results published in Lancet 2015; 385: 2272-79. Another single-center, open-label phase I clinical trial evaluating safety, tolerability and immunogenicity of Ad5-EBOV vaccine was established with 61 healthy Africans living in China age 18 to 60 years in First Affiliated Hospital of Medical College of Zhejiang University, started Apr 3, 2015 (Trial no. NCT 02401373). OBJECTIVE: Preliminarily evaluate safety, immunogenicity of Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) after one injection under dosage of 8×1010vp or 1.6×1011vp ; to determine appropriate dosage which could support large-scale phase III clinical trials
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Ad5 EBOV
Disease(s) or condition(s) being studied Ebola Virus Disease ,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention
Anticipated trial start date 01/10/2015
Actual trial start date
Anticipated date of last follow up 01/04/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Protocol No.:- JSVCT024; Approval No.: 2015L00399 Sponsors: Beijing Institute of Biotechnology, China & Tianjin CanSino Biotechnology Inc., China;
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ad5-EBOV vials (4×1010 vp/vial), one shot in each arm intramuscular, total dose of 1.6×1011vp, 6 months Single Centre 250
Experimental Group Ad5-EBOV Group B (4×1010vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×1010vp/vial), total dose of 8×1010vp, one shot in each arm intramuscular 6 months Single Centre 125
Control Group Ad5-EBOV Placebo group (0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp 6 months single centre 125 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Aged between 18 and 50 years 2. Able to understand the content of informed consent and signed the informed consent 3. Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months). 4. Negative in HIV diagnostic blood test on the day of enrollment 5. Axillaty temperature ?37.0°C on the day of enrollment 6. Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment 7. General good health as established by medical history and physical examination. 1. Infected by Ebola virus (inquiry) 2. Vaccination with other Ebola vaccine (inquiry) 3. HIV infection or other serious immunodeficiency disease (inquiry) 4. Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol 5. Family history of brain or mental disease 6.Woman who is pregnant or breast-feeding 7. Any acute fever disease or infections in last 7 days 8. Major congenital defects or not well-controlled chronic illness 9. Asplenia or functional asplenia 10. Platelet disorder or other bleeding disorder 11. Faint at the sight of blood or needles. 12. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months 13. Prior administration of other research medicines in last 1 month 14. Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives 18 Year(s) 50 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 10/08/2015 Sierra Leone Ethics & Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Connaught Hospital Freetown Central Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety: Occurrence of solicited adverse reactions within 7 days after vaccination 7 days after vaccination
Primary Outcome Immunogenicity: ELISA antigen-specific assays for antibody responses On 0 day; 14th day; 28th day; 168th day
Secondary Outcome Safety: Occurrence of unsolicited adverse reactions Within 28 days after vaccination
Secondary Outcome Safety: Occurrence of serious adverse reactions during whole follow-up period During entire 6 month follow-up period
Secondary Outcome Safety: Infection rate of HIV during the whole follow-up period During the entire 6 month follow-up period
Secondary Outcome Immunogenicity: Neutralizing antibody tiers response to human Ad5 On 0 day; 14th day; 28th day and 168th day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sierra Leone- China Friendship Hospital Waterloo Road Freetown Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
Beijing Institute of Biotechnology No. 20 Dongdajie street, Fengtai District Beijing 100071 China
Tianjin CanSino Biotechnology Inc., China Beijing China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ministry of Health & Sanitation Youyi Building Freetown Sierra Leone Commercial Sector/Industry
Primary Sponsor Beijing Institute of Biotechnology, China No. 20 Dongdajie street, Fengtai District, Beijing China Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Sierra Leone- China Friendship Hospital Management Waterloo Road Freetown Sierra Leone
henzhen Yingheyuan Medical Technology Development Co. Ltd 6B-01, Tian-xia Industrial Park, Ma Jia Long, Yi-yuan Road Nansha District, Shenzhen 518052 China
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alie H Wurie wuriealieh@yahoo.com +232-76671100 Emergency Operations Cetre, Wilkinson Road
City Postal code Country Position/Affiliation
Freetown Cockeril Sierra Leone Senior Public Health Physician Specialist
Role Name Email Phone Street address
Public Enquiries Edward Kargbo pdthealth@gmail.com +232-7939999 Jomo Kenyatta Road
City Postal code Country Position/Affiliation
Freetown New England Sierra Leone Communications Director- Ad5-EBOV
Role Name Email Phone Street address
Scientific Enquiries James W Russell? Russell jamesbwrussell@gmail.com +232-76412442 Sierra Leone- China Friendship Hospital
City Postal code Country Position/Affiliation
Freetown Jui Sierra Leone Clinical Director- Ad5-EBOV Phase II CT- SL
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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