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A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in African children living with HIV
Full description
This is a Phase Ib, open-label, non-randomised, controlled trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in 5-36 month old African children living with HIV.
The study will be conducted in Uganda at the MRC/UVRI and LSHTM Uganda research unit with recruitment taking place in Kampala, Wakiso and Entebbe.
Children aged 5-36 months will be recruited to the trial. 100 children with confirmed HIV infection will be recruited to group 1. 20 children without HIV infection will be recruited to group 2. Up to 10% variation for each group will be permitted to accommodate variation in the rate of recruitment and retention.
HIV positive children will be recruited from Paediatric HIV care centres within Kampala and Wakiso districts. HIV negative children will be recruited from Entebbe hospital and primary health care centres that provide immunisation and growth monitoring services.
All participants will receive 3 vaccinations of 5µg R21/50µg Matrix-M™. Participants will receive their first dose at 0 months, second dose at 1 month and third dose at 2 months. Participants will receive a booster at 14 months (12 months after their third dose). Participants will be followed up for 12 months following the primary vaccination series and 12 months following the booster dose.
Primary objective:
To assess the safety and reactogenicity profile of the malaria vaccine candidate R21/Matrix-M™ in 5-36-month old African children living with HIV
Secondary objectives:
Tertiary objective:
To assess the immunogenicity profile of R21/Matrix-M™ in 5-36-month-old African children, comparing children living with HIV with HIV negative children
This trial is funded by the Serum Institute of India Pvt Ltd.
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Inclusion criteria
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:
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
Primary purpose
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120 participants in 2 patient groups
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Central trial contact
Katie Ewer; Adrian Hill
Data sourced from clinicaltrials.gov
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