Status:
ACTIVE_NOT_RECRUITING
Assessment of Safety and Immunogenicity of R21/Matrix-M™ in African Children Living With HIV
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
MRC/UVRI and LSHTM Uganda Research Unit
Conditions:
Malaria
Eligibility:
All Genders
5-36 years
Phase:
PHASE1
Brief Summary
A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in African children living with HIV
Detailed 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 condu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05385510
Start Date
January 10 2023
End Date
September 1 2025
Last Update
October 22 2024
Active Locations (1)
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1
MRC/UVRI & LSHTM Uganda Research Unit
Entebbe, Uganda