Safety and Immunogenicity of the Malaria Vaccine Candidate BK-SE36 in Healthy Malaria-Exposed African Children Living in Burkina Faso
- Conditions
- Malaria
- Registration Number
- PACTR201411000934120
- Lead Sponsor
- obelpharma Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 108
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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