This is an open label, single-site, first-in-human, Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs25-IMX313 in Matrix-M1 adjuvant in healthy adults living in the UK Volunteers will receive 3 doses of vaccine over 2 months and will be followed up for approximately 8 months.
This Phase 1a clinical trial is designed primarily to assess the safety and tolerability of the Pfs25-IMX313/Matrix-M transmission blocking vaccine in healthy adult volunteers. An important secondary objective is to to assess the immune response to the vaccine. 8 volunteers will receive 3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56. Blood samples will be taken for safety testing and to collect information about the immune response. Any symptoms that occur after vaccination will also be recorded. Healthy volunteers aged 18-45 will be recruited in England at the Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1
3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom
Assessment of safety and reactogenicity through collection of data on the frequency, duration and severity of solicited and unsolicited adverse events.
The following parameters will be assessed: * Frequency, duration and severity of solicited local reactogenicity signs and symptoms for 7 days following each vaccination * Frequency, duration and severity of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Frequency, duration and severity of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety haematological and biochemical laboratory measures, which will presented according to local grading scales, for 28 days following vaccination * Frequency, duration and severity of serious adverse events during the whole study duration
Time frame: 8 months
Humoral and cellular immunogenicity of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers
Pfs25-specific immunogenicity will be assessed by immunological assays, with comparison before and after vaccination. The main outcome measures will be humoral and B cell responses to the Pfs25 protein - total IgG, isotypes and avidity; T cell responses to Pfs25 by ex vivo ELISpot and flow cytometry assays.
Time frame: 8 months
Ex-vivo efficacy of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers
Ex vivo functional blocking activity of purified IgG against the P. falciparum NF54 strain will be assessed by standard membrane feeding assay.
Time frame: 8 months
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