NCT04201431

Safety, Immunogenicity and Efficacy of the Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvDBPII in Matrix M1

A Phase I/IIa Clinical Trial to Assess the Safety, Immunogenicity and Efficacy of the Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvDBPII in Matrix M1 in Healthy Adults Living in the UK

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an Open label, first-in-human, Phase I/IIa, blood-stage P. vivax malaria vaccine trial to assess the safety, immunogenicity and efficacy of the blood-stage Plasmodium vivax malaria vaccine candidate PvDBPII in Matrix M1 in healthy adults living in the UK.

Detailed description

This Phase I/IIa clinical trial is designed to primarily assess the safety of the PvDBPII-Matrix M1 vaccine in healthy volunteers and to establish whether the PvDBPII-Matrix M1 vaccine can demonstrate a reduced parasite multiplication rate in vaccinated subjects compared to infectivity controls in a blood-stage controlled human malaria infection model. Up to 24 healthy volunteers aged 18-45 will be recruited in England at the Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford. Volunteers in Groups 1 and 2 will receive three doses of the PvDBPII 50ug/Matrix M1 50ug candidate vaccine prior to blood-stage CHMI 2-4 weeks after the third vaccination. Volunteers in Group 1 who complete 3 vaccinations and CHMI will be invited back for a fourth vaccination at 5 months following their third vaccination and form a new study group- Group 3. Volunteers will undergo blood stage CHMI with Plasmodium vivax. Volunteers in a parallel study (VAC069), who will undergo the same CHMI without prior vaccination, will be used as infectivity controls. Participants in Group 1 will be followed for approximately 9 months after the third vaccination, approximately 2 years in total from enrolment. Participants in Group 2 will be followed for 1 year from enrolment. Participants in Group 3 will be followed for 9 months after their final (fourth) vaccination, approximately up to 2.5 years in total from enrolment.

Conditions

• Malaria, Vivax

Interventions

Type	Name	Description
BIOLOGICAL	PvDBPII/Matrix-M1	50ug PvDBPII in 50ug Matrix M1

Timeline

• Start date: 2020-01-24
• Primary completion: 2022-07-14
• Completion: 2022-07-14
• First posted: 2019-12-17
• Last updated: 2024-11-25
• Results posted: 2024-11-25

Locations

1 site across 1 country: United Kingdom