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

Malaria, Vivax Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04201431
Study type Interventional
Source University of Oxford
Contact Volunteer Coordinator
Phone 01865 857406
Email vaccinetrials@ndm.ox.ac.uk
Status Recruiting
Phase Phase 1/Phase 2
Start date January 24, 2020
Completion date August 2022
View Details
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