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 - VAC079: Safety and efficacy of the PvDBPII in Matrix M1 vaccine

niversity of Oxford / Clinical Trials and Research Governance0 sites24 target enrollmentOctober 31, 2019

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Oxford / Clinical Trials and Research Governance

•Healthy adult aged 18 to 45 years.
•Red blood cells positive for the Duffy antigen/chemokine receptor (DARC).
•Normal serum levels of Glucose\-6\-phosphate dehydrogenase (G6PD).
•Negative haemoglobinopathy screen
•Able and willing (in the Investigator’s opinion) to comply with all study requirements.
•Willing to allow the Investigators to discuss the volunteer’s medical history with their General Practitioner.
•Women only: Must practice continuous effective contraception\* for the duration of the study
•Agreement to permanently refrain from blood donation
•Written informed consent to participate in the trial.
•Reachable (24/7\) by mobile phone during the period between CHMI and completion of all antimalarial treatment.

•History of clinical malaria (any species).
•Travel to a clearly malaria endemic locality during the study period or within the preceding six months.
•Current or planned treatment with long\-acting immune\-modifying drugs at any time during the study period (e.g. infliximab).
•Chronic use of antibiotics with antimalarial effects (e.g. tetracyclines for dermatologic patients, trimethoprim\-sulfamethoxazole for recurrent urinary tract infections, etc.).
•Weight less than 50kg, as measured at the screening visit
•Receipt of immunoglobulins within the three months prior to planned administration of the vaccine candidate.
•Receipt of blood products (e.g., blood transfusion) at any time in the past.
•Peripheral venous access unlikely to allow twice daily blood testing (as determined by the Investigator).
•Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
•Concurrent involvement in another clinical trial or planned involvement during the study period