This is an open label, single-site, first-in-human, dose-escalation Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs48/45 in Matrix-M adjuvant in healthy adults living in the UK
Volunteers will be recruited into one of three groups (n=8-10 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford over approximately 12 months. All volunteers will receive three dose of Pfs48/45 in 50 µg Matrix-M, administered intramuscularly and given four weeks apart. Enrolment will be staggered with clinical and safety reviews, follow-up visits and monitoring via a diary card.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
17
Three doses of Pfs48/45 in Matrix-M at different doses
CCVTM, Churchill Hospital, University of Oxford
Oxford, United Kingdom
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results
Time frame: 7 days following each vaccination
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results.
Time frame: 7 days following each vaccination
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination
Number of unsolicited adverse events (AEs) for 28 days following the vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results
Time frame: 28 days following the vaccination
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results
Occurrence of change from baseline laboratory tests
Time frame: 28 days following vaccination
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers Assessed Through the Number of Participants With Serious Adverse Events
Occurrence of serious adverse events will be presented according to local grading scales
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Time frame: Whole duration of the study (8 months following initial trial vaccination)
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers.
Occurrence of AEs of special interest will be presented according to local grading scales and will be described in detail
Time frame: Whole duration of the study (8 months following initial trial vaccination)
Humoral Immunogenicity of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers as Assessed by Humoral Responses to the Pfs48/45 Protein
Antibody responses to the Pfs48/45 protein will be assessed through total IgG isotypes and avidity
Time frame: Days 1, 29, 57, 140 and 240
Cellular Immunogenicity of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers as Assessed by Cellular Responses to the Pfs48/45 Protein
T cell responses to Pfs48/45 will be assessed by ex vivo enzyme-linked immunospot assays (ELISpot)
Time frame: Days 1, 29, 57, 140 and 240
Ex Vivo Efficacy of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers Using Direct Membrane Feeding Assays as Assessed by Transmission-reducing Activity
Transmission-reducing activity
Time frame: Days 1, 29, 57, 140 and 240
Ex Vivo Efficacy of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers Using Direct Membrane Feeding Assays as Assessed by Transmission-blocking Activity
Transmission-blocking activity
Time frame: Days 1, 29, 57, 140 and 240