Safety and Immunogenicity of the Malaria Vaccine Candidate BK-SE36/CpG in Healthy Malaria-Exposed African Adults and Children Living in Burkina Faso

Not Applicable

• Conditions: Malaria

• Registration Number: PACTR201701001921166
• Lead Sponsor: obelpharma Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Specific inclusion criteria for cohort 1 (adults 21-45 years old)
¿Female or male subjects aged 21 to 45 years inclusive at the time of the first vaccination
¿Residing within the Ouagadougou health region and planning to stay for the study duration
¿General good health based on medical history and clinical examination
¿Written informed consent obtained before any trial procedure
¿Female and male volunteers practicing /willing to practice contraceptive methods recommended by the national health system for at least four (4) weeks before the first vaccination (for female participants only) and up to four (4) weeks after the third vaccination.

Specific inclusion criteria for cohort 2 (children 5-10 years old)
¿Female or male subjects aged 5 to 10 years inclusive at the time of first vaccination.
Specific inclusion criteria for cohort 3 (children 12-24 months)
¿Female or male subjects aged 12 to 24 months inclusive at the time of first vaccination.
Common inclusion criteria for cohorts 2 and 3
¿Residing within the Ouagadougou health region and planning to stay for the study duration
¿Appear to be in generally good health based on malnutrition index and clinical and laboratory investigations
¿Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are not literate, the consent form will be countersigned by an impartial witness
¿Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) will be enrolled in the study. The trial period for each subject is 14 months (12 months + 8 weeks screening).

Exclusion Criteria

Specific non-inclusion criteria for cohort 1
¿ Positive pregnancy test
¿ Currently breastfeeding
¿ Suspected or current known alcohol or drug abuse

Specific non-inclusion criteria for cohort 3
¿Weight-for-age Z score of less than ¿3 or other relevant clinical signs of malnutrition

For cohort 1, 2 and 3
¿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. Specifically:
oHaemoglobin less than 8.0 g/dL,
oSerum Creatinine concentration greater than 70 µmol/L,
oSerum ALT concentration greater than 45 U/L,
oLow platelet count (< 100,000/mm3)
¿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
¿History of auto immune disease
¿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 to 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
¿Current participation in another clinical trial, or within 12 weeks of this study
¿Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the safety and reactogenicity of 3 doses of malaria vaccine candidate BK-SE36 mixed with CpG K3 ODN via the intramuscular route, in healthy African adults and children exposed to the parasite P. falciparum.The primary objective is restricted to serious or severe adverse events.

Secondary Outcome Measures

Name	Time	Method
¿Assess the humoral immune response to the vaccine antigens administered intramuscularly by measuring the level of IgG in all subjects ¿Assess the safety and reactogenicity of the BK-SE36/CpG vaccine restricted to mild or moderate adverse events.