EUCTR2019-000643-27-GB
Active, not recruiting
Phase 1
A Phase IIa challenge study to assess efficacy of the Plasmodium vivax malaria vaccine candidates ChAd63 PvDBP and MVA PvDBP in healthy adults living in the UK - VAC071: A study to assess efficacy of the ChAd63/MVA PvDBP vaccines
niversity of Oxford / Clinical Trials and Research Governance0 sites19 target enrollmentNovember 8, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Plasmodium vivax malaria
- Sponsor
- niversity of Oxford / Clinical Trials and Research Governance
- Enrollment
- 19
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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 immunoglobulins 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
Outcomes
Primary Outcomes
Not specified
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