Stopped: The study was terminated due to administrative delays in the approval of a substantial amendment to extend the shelf-life of Pvs25-IMX313. Regulatory approval was only received on 11 August 2023, after end of study visits had already been conducted.
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.
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Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Timeframe: 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.
Timeframe: 7 days following each vaccination
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
Timeframe: 28 days following each vaccination
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Timeframe: 28 days following vaccination
Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events
Timeframe: Whole duration of the study period (8 months following enrolment)