VAC079; a study to the assess the safety and efficacy of the malaria vaccine PvDBPII in Matrix M1

Phase 1

• Conditions: Plasmodium vivax malaria; MedDRA version: 20.0Level: LLTClassification code 10047665Term: Vivax malaria (benign tertian)System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2019-002872-14-GB
• Lead Sponsor: niversity of Oxford / Clinical Trials and Research Governance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-31
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•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.
•Willing to take a curative anti-malarial regimen following CHMI.
•Willing to reside in Oxford for the duration of the study, until antimalarials have been completed.
•Answer all questions on the informed consent quiz correctly at first or second attempt.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•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
•Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.

• Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt during the study period
•Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine e.g. egg products, Kathon
•History of allergic disease or reactions likely to be exacerbated by malaria infection.
•History of clinically significant contact dermatitis
•Any history of anaphylaxis in reaction to vaccinations
•Pregnancy, lactation or intention to become pregnant during the study.
•Use of medications known to cause prolongation of the QT interval and existing contraindication to the use of Malarone.
•Use of medications known to have a potentially clinically significant interaction with Riamet and Malarone.
•Any clinical condition known to prolong the QT interval.
•History of cardiac arrhythmia, including clinically relevant bradycardia.
•Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
•Family history of congenital QT prolongation or sudden death.
•Contraindications to the use of both of the proposed anti-malarial medications; Riamet Malarone.
•History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
•History of serious psychiatric condition that may affect participation in the study.
•Any other serious chronic illness requiring hospital specialist supervision.
•Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 25 standard UK units every week.
•Suspected or known injecting drug abuse in the 5 years preceding enrolment.
•Hepatitis B surface antigen (HBsAg) detected in serum.
•Seropositive for hepatitis C virus (antibodies to HCV) at screening or (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
•Positive family history in both 1st AND 2nd degree relatives < 50 years old for cardiac disease.
•Volunteers unable to be closely fol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified