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

This is an interventional prevention trial for Malaria Read More

Inclusion Criteria:

• 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.

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