VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M Vaccine
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|ClinicalTrials.gov Identifier: NCT04130282|
Recruitment Status : Terminated (Delays caused by Covid-19)
First Posted : October 17, 2019
Last Update Posted : September 29, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria,Falciparum||Biological: Pfs25-IMX313/Matrix-M1||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 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|
|Actual Study Start Date :||September 27, 2019|
|Actual Primary Completion Date :||September 22, 2020|
|Actual Study Completion Date :||September 22, 2020|
Experimental: Group 1
8 volunteers receiving 3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56
3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56
- Assessment of safety and reactogenicity through collection of data on the frequency, duration and severity of solicited and unsolicited adverse events. [ Time Frame: 8 months ]
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
- Humoral and cellular immunogenicity of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers [ Time Frame: 8 months ]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.
- Ex-vivo efficacy of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers [ Time Frame: 8 months ]Ex vivo functional blocking activity of purified IgG against the P. falciparum NF54 strain will be assessed by standard membrane feeding assay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130282
|CCVTM, University of Oxford, Churchill Hospital|
|Oxford, United Kingdom, OX3 7LE|
|Principal Investigator:||Angela Minassian, PhD||University of Oxford|