Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bag… (NCT04271306) | Clinical Trial Compass
TerminatedPhase 1
Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania.
Stopped: Due to significant delays in receiving local regulatory approval to extend the shelf-life of the IMP.
Tanzania34 participantsStarted 2021-05-25
Plain-language 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
Who can participate
Age range5 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy adult aged 18 to 45 years or children aged 5-12 years.
✓. Planned long-term (at least 30 months from the date of recruitment) or permanent residence in Bagamoyo town.
✓. 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.
✓. Able and willing (in the Investigator's opinion) to comply with all study requirements.
✓. Agreement to refrain from blood donation for the duration of the study
✓. Written informed consent to participate in the trial.
✓. Women only: Must practice continuous effective contraception\* for the duration of the study.
Exclusion criteria
✕. Use of immunoglobulins or blood products (e.g., blood transfusion) at any time in the past.
✕. Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 14 days following each vaccination.
✕. Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
✕. Concurrent involvement in another clinical trial or planned involvement during the study period
✕. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator
What they're measuring
1
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Timeframe: Assessment of solicited symptoms in the first 7 days post vaccination
2
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Timeframe: Assessment of unsolicited symptoms in the first 30 days post vaccination
3
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Timeframe: Assessment of SAEs until the end of the study (approx 2 years)
✕. 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).
✕. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products)
✕. Any history of anaphylaxis in reaction to vaccinations