Assessment of Safety and Immunogenicity of R21/Matrix-M™ in African Children Living With HIV

Exclusion Criteria

• •Previous receipt of a malaria vaccine.
• •Enrolment in another malaria intervention trial that could interfere with the results of this study.
• •History of severe allergic disease or reactions, including anaphylaxis or angioedema
• •History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines, or history of allergic reactions to previous vaccinations
• •Clinically significant laboratory abnormality as judged by the study clinician including haemoglobin of ≤8.0 g/dL .
• •Major congenital defects.
• •Receipt of blood transfusion, immunoglobulins and/or any blood products within the three months preceding enrolment
• •Malnutrition requiring hospital admission at the time of enrolment.
• •HIV disease of stage 3 or 4, as defined by the WHO clinical staging \[23\]
• •Confirmed or suspected immunosuppressive or immunodeficient state (other than due to HIV infection).
• •o This may include asplenia, use of immunosuppressant medication within the past 6 months (except for topical steroids or short-term oral steroids (course lasting \<14 days).
• •Autoimmune conditions (except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease)
• •Any other clinically significant disease or disorder, or social situation, elicited in medical history, physical examination or laboratory tests that, in the opinion of the study clinician, may:
• •* Put the participants at risk because of participation in the trial, or
• •* Influence the result of the trial, or
• •* Affect the participant's ability to participate in the trial
• •* These may include: diseases or disorders of the pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal systems, cancer, bleeding disorders, abnormalities of screening laboratory tests or examinations
• •Receipt of an investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• •Current participation in another clinical trial if likely to affect data interpretation of this trial