Malaria
Conditions
Interventions
Children 25-60 months, BK-SE36, subcutaneous
Children 25-60 months, BK-SE36, intramuscular
Children 12-24 months, BK-SE36, subcutaneous
Children 12-24 months, BK-SE36, intramuscular
Children 12-24 months,commercial control pneumococcal vaccine
Children 25-60 months,commercial control pneumococcal vaccine
Sponsors
Nobelpharma Co., Ltd
Research Institute for Microbial Diseases (RIMD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the humoral immune response to the vaccine antigens administered subcutaneous or intramuscularly by measuring the level of IgG;Assess the quality of the humoral immune response by measuring IgG1, IgG3 subclasses;Assess T cell cytokines IL-5, IL-13, and IFN¿ production | — |
Countries
Burkina Faso
Contacts
Public ContactSophie Houard
Vaccine development leader at EVI
Outcome results
None listed