ACTRN12612001153808
Completed
Phase 1
Characterisation of the in vivo infectivity of the Plasmodium falciparum NF54 cell bank, MCB-002, in malaria naive adults
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Griffith University
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males aged 18\-45yrs who do not live alone from D1 until at least the end of anti\-malarial treatment
- •2\. Body Mass Index within range of 18\-30
- •3\. Contactable and available for the duration of the trial (90 days)
- •4\. Non\-smokers and in good health as assessed during pre\-study medical examination and by review of screening results
- •5\. Good peripheral venous access
Exclusion Criteria
- •1\. History of malaria.
- •2\. Travelled to or lived (\>2 weeks) in a malaria\-endemic country during the past 12 months or planned travel to a malaria\-endemic country during the course of the study.
- •3\. Has evidence of increased cardiovascular disease risk (defined as \>10%, 5 year risk) as determined by the method of Gaziano et al. Risk factors include sex, age, systolic blood pressure (mm Hg), smoking status, body mass index (BMI, kg/mm2\), reported diabetes status and blood pressure.
- •4\. History of splenectomy.
- •5\. History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination, infusion or treatment with the anti\-malarial drugs artemether and/or lumefantrine.
- •6\. Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immunodeficiencies), insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, psoriasis, rheumatoid arthritis, asthma, epilepsy or obsessive compulsive disorder, skin carcinoma excluding non\-spreadable skin cancers such as basal cell and squamous cell carcinoma.
- •7\. Known inherited genetic anomaly (known as cytogenetic disorders) e.g., Down’s syndrome.
- •8\. Individuals wishing to donate blood to the Australian Red Cross Blood Service during the study or within 6 months of administration of the malaria inoculum.
- •9\. The volunteer has a diagnosis of schizophrenia, severe depression, bi\-polar disease, or other severe (disabling) chronic psychiatric diagnosis. Participants who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating may be allowed to enroll in the study at the investigator’s discretion.
- •10\. Known pre\-existing prolongation of the QTc interval. Family history of congenital prolongation of the QTc interval on electrocardiograms or of sudden death or any other clinical condition known to prolong the QTc interval, e.g. volunteers with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
Outcomes
Primary Outcomes
Not specified
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