This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.
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 18 months. All volunteers will receive three doses of Pvs25-IMX313 in Matrix-M1, 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
25
Three doses of Pvs25-IMX313 in Matrix-M1 at different concentrations
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Number of participants in each group who reported solicited local reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited local reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Time frame: 7 days following each vaccination
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Number of participants in each group who reported solicited systemic reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited systemic reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Time frame: 7 days following each vaccination
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
Unsolicited adverse events were collected for 28 days following each vaccination through participant-reported e-diaries.
Time frame: 28 days following each vaccination
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Occurrence of change from baseline laboratory test results
Time frame: 28 days following vaccination
Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events
Number of serious adverse events reported per group throughout the study period.
Time frame: Whole duration of the study period (8 months following enrolment)
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Humoral Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Humoral Responses to the Pvs25 Protein
Antibody responses to the Pvs25 protein will be assessed through total IgG isotypes and avidity
Time frame: Days 1, 29, 57, 140 and 240.
Cellular Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Cellular Responses to the Pvs25 Protein.
T cell responses to Pvs25 will be assessed by ex vivo enzyme-linked immunospot assays (ELISpot) and flow cytometry assays.
Time frame: Days 1, 29, 57, 140 and 240.
Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Reducing Activity
Transmission-reducing activity will be assessed through direct membrane feeding assays (DMFA).
Time frame: Days 1, 29, 57, 140 and 240.
Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Blocking Activity
Transmission-blocking activity will be assessed through direct membrane feeding assays (DMFA).
Time frame: Days 1, 29, 57, 140 and 240.