Adjuvanting Viral Vectored Malaria Vaccines With Matrix M

This is an interventional prevention trial for Malaria focused on measuring Malaria vaccine, Matrix M Read More

Inclusion Criteria:

• Healthy adult aged 18 to 50 years
• Able and willing (in the Investigator's opinion) to comply with all study requirements
• Willing to allow the investigators to discuss their medical history with their General Practitioner
• For female volunteers, willingness to practice continuous effective contraception during the study
• For male volunteers, must use barrier contraception for 3 months from the day of any administration of Matrix M™
• Agreement to refrain from blood donation during the course of the study and for 6 months after the end of their involvement in the study
• Written informed consent

Exclusion Criteria:

• Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
• Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections; and chronic (more than 14 days) immunosuppressant medication use within the past 6 months (inhaled and topical steroids are allowed)
• Pregnancy, lactation, or intention to become pregnant during the study
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon
• History of clinically significant contact dermatitis Any history of anaphylaxis or hypersensitivity in relation to vaccination
• History or evidence of pre-existing autoimmune or antibody-mediated disease or laboratory evidence of possible autoimmune disease, defined as a positive antinuclear antibody (ANA) result at screening.
• Any history of malaria
• Travel to a malaria endemic region during the study period or within the six months preceding enrolment in the study with significant risk of malaria infection
• History of serious psychiatric condition that may affect participation in the study
• Any other serious chronic illness requiring hospital specialist supervision
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Suspected or known injecting drug abuse in the five years preceding enrolment
• Seropositive for hepatitis B surface antigen (HBsAg)
• Seropositive for hepatitis C virus (antibodies to HCV)
• Any relevant history of cancer (excludes basal cell carcinoma of the skin and cervical carcinoma in situ)
• Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
• Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of study data