ISRCTN95289709
Active, not recruiting
Phase 1
Phase I clinical trial to assess the safety and immunogenicity of the malaria vaccine candidate RH5.1 soluble protein in Matrix-MTM using two dosing regimens
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malaria (African strain)
- Sponsor
- niversity of Oxford
- Enrollment
- 23
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy adult aged 18 to 50 years
- •2\. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •3\. Willing to allow the Investigators to discuss the volunteer’s medical history with their GP
- •4\. Participants of childbearing potential only: must practice continuous effective contraception for the duration of the study (see section 9\.9\)
- •5\. Agreement to refrain from blood donation for the duration of the study
- •6\. Able and willing to provide written informed consent to participate in the trial
Exclusion Criteria
- •1\. History of clinical malaria (any species) or previous participation in any malaria (vaccine) trial or controlled human malaria infection (CHMI) study
- •2\. Travel to a clearly malaria endemic locality during the study period or within the preceding 6 months
- •3\. Use of immunoglobulins or blood products (e.g. blood transfusion) in the last 3 months
- •4\. Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of COVID\-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination
- •5\. Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
- •6\. Concurrent involvement in another clinical trial involving an investigational product or planned involvement during the study period
- •7\. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator
- •8\. 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)
- •9\. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- •10\. Any history of anaphylaxis
Outcomes
Primary Outcomes
Not specified
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