This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.
There will be six study groups. Group 1 will consist of 8 adults who will receive three doses of 5 µg R21 + 10 µg RH5.1 + 10 µg R78C. Group 2 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg RH5.1. Group 3 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg R78C. Group 4 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg RH5.1 +10 µg R78C. Group 5 will consist of 8 children who will receive three doses of 5 µg R21. Group 6 will consist of 16 children who will receive three doses of 10 µg RH5.1 +10 µg R78C. All vaccinations will be given in 50 µg Matrix-M. All groups will receive their vaccinations in a 0-1-6 month regimen. Groups 1 to 4 and 6 will be recruited in a staggered process. There will be a DSMB review prior to age deescalation. There will also be three sentinel participants per group and DSMB reviews prior to each subsequent (second and third) vaccination. Group 5 can be recruited at any time and without need for sentinel participants or DSMB review.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
56
Institut de Recherche en Sciences de la Santé
Siglé, Boulkiemdé Province, Burkina Faso
RECRUITINGSafety: To assess the safety and reactogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area.
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The following parameters will be assessed: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination (day of vaccination and 6 subsequent days) * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination (day of vaccination and 6 subsequent days) * Occurrence of unsolicited adverse events for 28 days following the vaccination (day of vaccination and 27 subsequent days) * Clinically significant change from baseline for safety laboratory measures throughout the study * Occurrence of serious adverse events during the whole study duration.
Time frame: Solicited AEs will be assessed at Day 0, Days 1-6, 28, days 29-34, 182 and days 187. Unsolicited AEs on Day 0, Days 1-6, 14, 28, Days 29-34, 42, 56, 182, Days 183-187 and 196. All SAEs will be assessed throughout the study follow up period upto Day 365
Immunogenicity: To assess the humoral immunogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area.
Immunogenicity will be assessed by a variety of immunological assays. The following measures will be assessed: * Serum response: o Quantitative antigen-specific IgG antibody levels (µg/mL readout) over time - analysis of peak responses and longevity; * In vitro GIA against 3D7 clone P. falciparum parasites using purified total IgG and a single-cycle pLDH readout assay
Time frame: Immunology blood samples will be collected at screening, day of vaccination, at Days 42, 56, 182, 196, 210, 240, and 365.
Angela Minassian, Honorary Consultant and CI
CONTACT
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