This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.
The study includes three age groups: Group 1: healthy adults (18-45 years) Group 2: young children (aged 1-5 years) Group 3: infants (aged 5- \<12 months of age) Each group will receive 3 vaccine doses which will be 4-weeks apart. A booster dose will be administered at 9-25 months post 3rd dose. The trial is funded by The European \& Developing Countries Clinical Trials Partnership (EDCTP), European Union, ref: RIA2016V-1649 MMVC
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant.
KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
Kilifi, Kenya
To evaluate the safety and tolerability of R21 with adjuvant Matrix-M in healthy adults then children and finally infants.
Solicited and unsolicited adverse event data will be collected at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results. This AE data will be tabulated and frequency, duration and severity of AEs compared between groups. The following parameters will be assessed for all study groups: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety laboratory measures * Occurrence of serious adverse events during the whole study duration
Time frame: up to 2 years following vaccination
To assess the cellular and humoral immunogenicity of R21 in humans with adjuvant Matrix- M in healthy adults, children and infants.
Comparison of immunogenicity (antibody responses) of the R21-Matrix-M1 - adjuvanted vaccination doses and the longevity of responses. * ELISA to quantify antibodies to the vaccine components CS, NANP and HBsAb. * Flow cytometry assays with intracellular cytokine staining to enumerate and functionally characterise immune cell populations such as effector and memory T cells (e.g. CD4+ and CD8+), T follicular helper cells, regulatory T cells, B cells, plasma cells and dendritic cells * ELISPOT for enumeration of antibody-secreting cells (e.g. B and plasma cells)
Time frame: up to 2 years following vaccination
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