Malaria,Falciparum
Conditions
Keywords
Vaccine
Brief summary
A phase Ib age de-escalation and dose escalation open label clinical trial of the safety, immunogenicity and ex-vivo efficacy of a candidate malaria vaccine Pfs25-IMX313/Matrix-M administered intramuscularly in healthy adults and young children in Tanzania
Detailed description
This study aims to evaluate safety, immunogenicity, and transmission blocking activity of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria in Bagamoyo district, Tanzania. The study will enrol 45 volunteers comprising of 13 adults (18-45 years) and 32 children (5-12 years).
Interventions
BIOLOGICALPfs25-IMX313 (10ug)/Matrix-M (50ug)
3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)
BIOLOGICALPfs25-IMX313 (50ug)/Matrix-M (50ug)
3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)
BIOLOGICALPfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)
2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg)
Sponsors
Ifakara Health Institute
University of Oxford
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult aged 18 to 45 years or children aged 5-12 years. 2. Planned long-term (at least 30 months from the date of recruitment) or permanent residence in Bagamoyo town. 3. Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or children (5-12 years) with the BMI between 13 and 25 Kg/m2. 4. Able and willing (in the Investigator's opinion) to comply with all study requirements. 5. Agreement to refrain from blood donation for the duration of the study 6. Written informed consent to participate in the trial. 7. Women only: Must practice continuous effective contraception\* for the duration of the study.
Exclusion criteria
1. Use of immunoglobulins or blood products (e.g., blood transfusion) at any time in the past. 2. Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 14 days following each vaccination. 3. Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period. 4. Concurrent involvement in another clinical trial or planned involvement during the study period 5. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator 6. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). 7. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products) 8. Any history of anaphylaxis in reaction to vaccinations 9. Pregnancy, lactation or intention to become pregnant during the study. 10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 11. History of serious psychiatric condition that may affect participation in the study. 12. Any other serious chronic illness requiring hospital specialist supervision. 13. Suspected or known injecting drug abuse in the 5 years preceding enrolment. 14. Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG). 15. Volunteers unable to be closely followed for social, geographic or psychological reasons. 16. Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of clinically significant abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria. | Assessment of solicited symptoms in the first 7 days post vaccination | Occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Pfs25 specific antibody responses following immunization with different vaccination regimens in healthy Tanzanian adults and children. | Duration of the study (approx 2 years) | Pfs25 antibody levels elicited by Pfs25IMX313-Matrix-M as measured by ELISA at each time point where serology samples are analysed. |
| Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA). | Duration of the study (approx 2 years) | Transmission blocking activity (TBA) of induced antibody as measured in standard membrane feeding assays (SMFA) and Direct Membrane feeding assays (DMFA). |
| Select the best vaccination regimen based on the peak Pfs25 specific antibodies after final immunization, their duration and transmission blocking activity by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA). | Duration of the study (approx 2 years) | The vaccination schedule that lead to the highest peak and duration of anti-Pfs25 antibody response post vaccination, and the highest transmission blocking activity (TBA) as measured by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA). |
Countries
Tanzania
Outcome results
None listed