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.: PACTR201610001813366 Date of Approval: 06/10/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Study to assess the Safety and Immunogenicity of the MAlaria Vaccine, R1, With Matrix-M1 Adjuvant
Official scientific title A Phase Ib Randomised, Controlled, Single-blind Study to Assess the Safety, Immunogenicity of the Malaria Vaccine Candidate R21 With Matrix-M1 Adjuvant in West African Adult Volunteers
Brief summary describing the background and objectives of the trial A randomised, controlled, single-blind clinical trial to evaluate the safety and immunogenicity of the malaria vaccine candidate regime of three (3) doses of R21/Matrix-M1 compared with placebo, in healthy West African adult volunteers living in a malaria-endemic area. The study will take place at the Centre National de Recherche et de Formation sur la Paludisme (CNRFP)/Unite de Recherche Clinique de Banfora (URC-B). Trial participants will be drawn from the Banfora Health Demographic system, which covers a total population of 30, 000. Volunteers will be randomised to receive either three (3) doses of R21/ Matrix-M1 or placebo (normal saline) as control. Simple randomisation into the study groups will be done by an independent statistician based at the University of Oxford. A randomisation code list will be generated by the independent statistician and its use guided by a clear Standard Operating Procedure (SOP). Allocation concealment will be employed by use of opaque sealed envelopes. As this is a single-blind clinical trial design, the laboratory scientists will be blinded to vaccine allocation until the end of the study. Each volunteer will be monitored for one hour (or longer if necessary) after each vaccination. Each volunteer will be visited at home daily for 6 days after each vaccination (Days 0, 28, and 56) by a field worker for assessment and recording of any solicited and unsolicited AEs in diary cards. If necessary the volunteer will continue to be seen regularly until any observed AEs have resolved or stabilised. Scheduled visits at the CNRFP will be on Days 0, 7, 28, 35, 56, 63, 84, and 140. All volunteers will be followed up to Day 140 post-first vaccination for adverse events.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VAC 060
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 15/08/2016
Actual trial start date 26/08/2016
Anticipated date of last follow up 31/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants) 24
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal Saline Three doses 3 months Saline 8 Placebo
Experimental Group R21/Matrix-M1 Three doses one month apart 3 months Malaria Vaccine Candidate 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The volunteer must satisfy all the following criteria to be eligible for the study: Healthy adults ages 18 to 45 years. Willingness to remain in study area for the period of the study. Able and willing (in the Investigator's opinion) to comply with all study requirements. Women only: Must practice and show documented evidence of continuous effective contraception (e.g. depo-progesterone) or must be willing to take contraceptive measures not to become pregnant for the duration of the study. Willing to have pregnancy tests at screening and vaccination time points. Agreement to refrain from blood donation during the course of the study. Written informed consent to participate in the trial. Hb less than 10.0g/dl Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period. Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant or other immune-modifying drugs medication (for corticosteroids, this will mean prednisolone, or equivalent, ¿ 0.5mg/kg/day) within the past 6 months (inhaled and topical steroids are allowed). Use of immunoglobulins or blood products within 3 months prior to enrolment. History of allergic disease or hypersensitivity reactions likely to be exacerbated by any component of the study vaccines. Any history of anaphylaxis post-vaccination. History of clinically significant contact dermititis. Pregnancy, lactation or intention to become pregnant during the study. Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). History of serious psychiatric condition that may affect participation in the study. History of splenectomy. Any other serious chronic illness requiring hospitalsupervision. HIV or Hepatitis B surface antigen seropositivity. Volunteers unable to be closely followed for social, geographic or psychological reasons. Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat test will be requested. Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data 18 Year(s) 45 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 04/11/2015 Comité d'éthique pour le Recherche en Santé (CERS) Burkina Faso
Ethics Committee Address
Street address City Postal code Country
Not applicable Ouagadougou 7009 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the safety and reactogenicity of three (3) doses of 10 & 50 ¿g of the malaria vaccine candidate R21 adjuvanted with Matrix-M1, given intramuscularly at 0, 1, 2 months schedule in healthy West African adult volunteers living in a malaria-endemic area. Solicited adverse events will be measured up to 7 days after each vaccination. Unsolicited adverse events will be measured up to 28 days after each vaccination. Serious adverse Events will be measured up to 140 days after first dose.
Secondary Outcome To assess the immunogenicity of three (3) doses of 10 & 50 ¿g of the malaria vaccine candidate R21 adjuvanted with Matrix-M1, given intramuscularly at 0, 1, 2 months schedule in healthy West African adult volunteers living in a malaria-endemic area. Days 0, 7, 28, 35, 56, 63, 84, 140
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre National de Recherche et de Formatation sur le Paludisme (CNRFP)/Unite de Recherche Clinique de Banfora (URC-B) Regional Hospital Banfora Banfora 2208 Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
Oxford University Oxford University Churchill Hospital Oxford Oxford OX3 7LJ United Kingdom
EDCTP Anna van Saksenlaan 51 The Hague 2593 HW Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oxford University Oxford University Churchill Hospital Oxford Oxford OX3 7LJ United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Oxford University Oxford University Churchill Hospital Oxford Oxford OX3 7LJ United Kingdom
CNRFP 01 BP 2208 Ouagadougou 01 Burkina Faso
European Vaccine Initiative UniversitätsKlinikum Heidelberg Heidelberg Vossstrasse 2, Geb. Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tiono B. Alfred t.alfred@fasonet.bf +22670285726 1487, Avenue Kumda Yonré
City Postal code Country Position/Affiliation
Ouagadougou 01 Burkina Faso Head Public Health Department/CNRFP
Role Name Email Phone Street address
Public Enquiries Sirima Sodiomon Bienvenu s.sirima.cnlp@fasonet.bf +22670200444 1487, Avenue Kumda Yonré
City Postal code Country Position/Affiliation
Ouagadougou 01 Burkina Faso Senior Scientist, CNRFP
Role Name Email Phone Street address
Scientific Enquiries Hill Adrian V. adrian.hill@ndm.ox.ac.uk +441865 617610 Oxford OX3 7LJ
City Postal code Country Position/Affiliation
Oxford Oxford OX3 7LJ United Kingdom Director, The Jenner Institute, University of Oxford
REPORTING
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