NCT04130282

VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M Vaccine

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	Pfs25-IMX313/Matrix-M1	3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56

Timeline

• Start date: 2019-09-27
• Primary completion: 2020-09-22
• Completion: 2020-09-22
• First posted: 2019-10-17
• Last updated: 2020-09-29

Locations

1 site across 1 country: United Kingdom