This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.
This is a study to assess safety and immunogenicity of a novel dosing regimen for R21/ Matrix-M™, a leading Plasmodium falciparum malaria vaccine, in healthy, malaria-naïve adults. Participants in the study will receive either 6 escalating doses (groups 1 and 2) or 2 standard doses (group 3) of R21/ Matrix-M™, all delivered in the same arm. Up to 36 volunteers will be enrolled and followed up for 12-24 months after their first vaccine. In addition to blood sampling throughout the follow-up period, participants will undergo fine needle aspiration of axillary lymph nodes twice during the study, to allow further characterisation of immune responses to this novel vaccine regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
36
* 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0) * 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3) * 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7) * 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10) * 5 mcg R21 in 25 mcg Matrix-M™ (D14) * 10 mcg R21 in 50 mcg Matrix-M™ (D56)
Group 2A: * 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0) * 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3) * 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7) * 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10) * 5 mcg R21 in 25 mcg Matrix-M™ (D14) * 10 mcg R21 in 50 mcg Matrix-M™(D168) Group 2B: * 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0) * 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3) * 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7) * 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10) * 5 mcg R21 in 25 mcg Matrix-M™ (D14) * 10 mcg R21 in 50 mcg Matrix-M™(D280)
Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford
Oxford, Oxfordshire, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of solicited adverse events in each group
Occurrence of solicited local and systemic reactogenicity signs and symptoms will be collected for 7 days following each vaccination. Solicited adverse event data will be tabulated, detailing frequency, duration and severity of the AEs.
Time frame: 7 days post-vaccination
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of unsolicited adverse events and laboratory adverse events in each group
Occurrence of unsolicited adverse events and changes from baseline in laboratory safety measures will be collected for 28 days following each vaccination. Unsolicited AE data will be tabulated, detailing frequency, duration and severity of AEs. Hematological and biochemical laboratory values will be presented according to local grading scales.
Time frame: 28 days post-vaccination.
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of serious adverse events in each group
Occurrence of serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawal due to AE(s)/SAE(s) will be described in detail.
Time frame: For the follow-up period of the study, between 1-2 years
Humoral immunogenicity of R21/Matrix-M™ administered in an escalating dose, multi-prime vaccination schedule verus a standard prime-boost regimen in healthy UK adults
Antibody dynamics will be assessed by measuring NANP-IgG at baseline and various timepoints during the trial.
Time frame: For the follow-up period of the study, between 1-2 years
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* 10 mcg R21 in 50 mcg Matrix-M™ (D0) * 10 mcg R21 in 50 mcg Matrix-M™ (D56)
Participants in all groups will undergo fine needle aspiration (FNA) of axillary lymph nodes draining vaccination site on Day 77 and Day 105 after initial vaccination.