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.: PACTR201411000934120 Date of Approval: 08/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and Immunogenicity of the Malaria Vaccine Candidate BK-SE36 in Healthy Malaria-Exposed African Children Living in Burkina Faso
Official scientific title Safety and immunogenicity evaluation of recombinant E.coli BK-SE36 malaria vaccine candidate with aluminium hydroxide gel as adjuvant administered either subcutaneously or intramuscularly in healthy malaria exposed African children living in Burkina Faso: A double blinded, randomized, controlled, age de-escalating, phase Ib clinical trial followed by an extended single blind follow up phase.
Brief summary describing the background and objectives of the trial The malaria vaccine candidate BK-SE36 is based on a recombinant form of the Plasmodium falciparum serine repeat antigen (SERA). The vaccine candidate was selected for clinical development on the following basis: (i)epidemiological studies showing high antibody titers that inversely correlate with malaria symptoms and severe disease; (ii) in vitro studies demonstrating induction of antibodies that are inhibitors of parasite growth, exert antibody-dependent complement-mediated lysis of schizonts, or antibody-dependent monocyte-mediated parasite growth inhibition; and (iii) animal studies demonstrating protection against P. falciparum challenge in non-human primates. The safety and immunogenicity of BK-SE36 was demonstrated in a phase Ia trial in malaria naive Japanese adults; and in a phase Ib trial conducted in healthy subjects aged 6-32 years from a malaria endemic area in Northern Uganda. The proposed clinical phase Ib trial conducted in Burkina Faso will allow for (i) testing of the vaccine candidate in a younger age group (1-5 years old), (ii) generation of additional information/data on safety, immunogenicity and preliminary possible efficacy, and (iii) comparison of clinical trial results from two different African countries with different malaria endemicity -Uganda and Burkina Faso-.
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 Malaria
Purpose of the trial Prevention
Anticipated trial start date 15/05/2015
Actual trial start date 24/06/2015
Anticipated date of last follow up 03/02/2017
Actual Last follow-up date 08/02/2017
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
BK-SE36/003/P01
BK-SE36/003
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 Permuted block randomisation (variable block size, random mixture of block size of 6 and 9) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Children 25-60 months, BK-SE36, subcutaneous 100µg SE36/1mg Aluminium hydroxide 3 times Week 0, 4 and 26 100 µg SE36/1mg Aluminium hydroxide will be given by subcutaneous route to children aged 25 to 60 months 18
Experimental Group Children 25-60 months, BK-SE36, intramuscular 100 µg SE36/1mg Aluminium hydroxide 3 times Week 0, 4 and 26 100 µg SE36/1mg Aluminium hydroxide will be given by intramuscular route to children aged 25 to60 months 18
Experimental Group Children 12-24 months, BK-SE36, subcutaneous 100 µg SE36/1mg Aluminium hydroxide 3 times Week 0, 4 and 26 100 µg SE36/1mg Aluminium hydroxide will be given by subcutaneous route to children aged 12 to 24 months 18
Experimental Group Children 12-24 months, BK-SE36, intramuscular 100µg SE36/1mg Aluminium hydroxide 3 times Week 0, 4 and 26 100 ug SE36/1mg Aluminium hydroxide will be given by intramuscular route to children aged 12 to 24 months 18
Control Group Children 12-24 months,commercial control pneumococcal vaccine 1 dose, 2 times Week 0 and 26 Commercial pneumococcal vaccine will be administered by intramuscular route on two occasions alternating with physiological saline in children aged 12 to 24 to months 18 Active-Treatment of Control Group
Control Group Children 25-60 months,commercial control pneumococcal vaccine 1 dose, 2 times Week 0 and 26 Commercial pneumococcal vaccine will be administered by intramuscular route on two occasions alternating with physiological saline in children aged 25 to 60 months 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Specific inclusion criteria for cohort 1 (25-60 months): Female or male subject aged 25-60 months inclusive at the time of the first vaccination Specific inclusion criteria for cohort 1 (25-60 months): Female or male subject aged 25-60 months inclusive at the time of the first vaccination Residing within the Banfora health district and planning to stay for the study duration Appear to be in generally good health based on malnutrition index and clinical and laboratory investigation Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by an impartial witness. Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study. The trial period for each subject is ca 18 months. Previous participation in any malaria vaccine trial History of blood transfusion within the last 3 months Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the volunteers Any clinically significant laboratory abnormalities on screened blood samples outside the normal range, as defined at the clinical trial site. Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior to recruitment. (For corticosteroids, this will mean prednisone, or equivalent, ¿ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination (No testing will be done for HIV) A family history of congenital or hereditary immunodeficiency Major congenital defects Subjects with splenectomy History of anaphylaxis or known severe hypersensitivity to any of the vaccine components (adjuvant or antigen or excipient) Administration of gamma globulin: 4 weeks prior and after each vaccination if administration is necessary during the study period, the volunteer will be withdrawn from the study Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period Weight-for-age Z score of less than ¿3 or other clinical signs of malnutrition Current participation in another clinical trial, or within 12 weeks of this study 12 Month(s) 60 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 15/11/2014 Comité Institutionnel de Bioéthique du CNRFP
Ethics Committee Address
Street address City Postal code Country
01 BP 2208 Ouagadougou 01 Ouagadougou Burkina Faso
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 04/12/2014 Comité d'éthique pour la recherche en santé
Ethics Committee Address
Street address City Postal code Country
Ouagadougou Burkina Faso
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 29/05/2015 Research Ethics Committeee in Osaka University
Ethics Committee Address
Street address City Postal code Country
Osaka Japan
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 24/04/2015 Osaka University Research Ethical Review Board
Ethics Committee Address
Street address City Postal code Country
Osaka Japan
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 19/05/2015 London School of Hygiene & Tropical Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assess the safety and reactogenicity of 3 doses of 100 µg BK-SE36 malaria vaccine candidate with aluminium hydroxide gel as adjuvant, in either subcutaneous or intramuscular route, in healthy African children exposed to the parasite Plasmodium falciparum. The safety criteria will be as defined by the Brighton Collaboration. week 0 week 1 week 4 week 5 week 8 week 26 week 27 week 32 week 52 week 68
Secondary Outcome Assess the humoral immune response to the vaccine antigens administered subcutaneous or intramuscularly by measuring the level of IgG day 0 week 4 week 8 week 26 week 30 week 52
Secondary Outcome Assess the quality of the humoral immune response by measuring IgG1, IgG3 subclasses week 8 week 30
Secondary Outcome Assess T cell cytokines IL-5, IL-13, and IFN¿ production day 0 week 8 week 30 week 52
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre National de Recherche et de Formation sur le Paludisme (CNRFP) Unité de Recherche clinique de Banfora (CNRFP/URC-B) 01 BP 2208 Ouagadougou 01 Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Health Innovative Technology Fund Ark Hills Sengokuyama Mori Tower 25F, 1-9-10 Roppongi, Minato-ku, Tokyo 106-0032 Japan
Nobelpharma Co., Ltd. Kyodo Bldg. (Horidome) 12-10 Nihonbashi-kobunacho, Chuo-Ku Tokyo 103-0024 Japan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nobelpharma Co., Ltd Kyodo Bldg. (Horidome) 12-10 Nihonbashi-kobunacho, Chuo-Ku Tokyo 103-0024 Japan Commercial Sector/Industry
Secondary Sponsor Research Institute for Microbial Diseases (RIMD) Osaka University 3-1 Yamadaoka, Suita Osaka 565-0871 Japan University
COLLABORATORS
Name Street address City Postal code Country
Centre National de Recherche et de Formation sur le Paludisme (CNRFP) 1487 Avenue Kumda Yonré Ouagadougou 01 Burkina Faso
Research Institute for Microbial Diseases (RIMD) Osaka University 3-1 Yamadaoka, Suita Osaka 565-0871 Japan
European Vaccine Initiative UniversitätsKlinikum Heidelberg Vossstrasse 2, Geb. 4040 Heidelberg 69115 Germany
London School of Hygiene & Tropical Medicine Keppel street London WC1E 7HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sodiomon Sirima s.sirima.cnlp@fasonet.bf +226 702 004 44 1487 Avenue Kumda Yonré
City Postal code Country Position/Affiliation
Ouagadougou 01 Burkina Faso Executive Director of CNRFP
Role Name Email Phone Street address
Public Enquiries Sophie Houard sophie.houard@euvaccine.eu +32 2 372 31 91 Universitätsklinikum, Im Neuenheimer Feld 326
City Postal code Country Position/Affiliation
Heidelberg 69120 Germany Vaccine development leader at EVI
Role Name Email Phone Street address
Scientific Enquiries Toshihiro Horii horii@biken.osaka-u.ac.jp +81(6)-6879-8280 Osaka University 3-1 Yamadaoka, Suita
City Postal code Country Position/Affiliation
Osaka 565-0871 Japan Head of the Department of Molecular Protozoology at Osaka University
REPORTING
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