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

Prior treatment

• Previous receipt of a malaria vaccine.
• 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
• 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.

Other illness

• History of severe allergic disease or reactions, including anaphylaxis or angioedema
• 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)

Lab values

• Clinically significant laboratory abnormality as judged by the study clinician including haemoglobin of ≤8.0 g/dL .
• 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

Other

• Enrolment in another malaria intervention trial that could interfere with the results of this study.
• 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.
• Current participation in another clinical trial if likely to affect data interpretation of this trial

• The child must be 5-36 months of age at enrolment (i.e. up to the day of their third birthday).
• Group 1: The child must have HIV infection (documented positive DNA PCR) with WHO stage 1 or 2 HIV disease, whether or not they are receiving ART.
• Group 2: The child must not have HIV infection (absence of HIV infection must be confirmed by documented negative DNA PCR at screening).
• Witnessed, signed/thumb-printed informed consent, obtained from the parent(s)/guardian(s) of the child
• Parents/guardians of the child are able and willing to comply with the requirements of the protocol, in the opinion of the investigator
• The child must be a permanent resident of the study area and likely to remain resident for the duration of the trial.