ACTRN12623001326684
Recruiting
Phase 1
A pilot study to characterise the in vivo safety and infectivity of an in vitro expanded Plasmodium knowlesi YH1-HS master cell bank in healthy participants
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- QIMR Berghofer Medical Research Institute
- Enrollment
- 4
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female (non\-pregnant, non\-lactating) aged 18 to 55 years inclusive who will be contactable and available for the duration of the trial and up to two weeks following the EOS visit.
- •2\. Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive).
- •3\. Certified as healthy by a comprehensive clinical assessment (detailed medical history and full physical examination).
- •4\. Vital signs at screening (measured after 5 min in the supine position):
- •Systolic blood pressure (SBP) \- 90–140 mmHg,
- •Diastolic blood pressure (DBP) \- 40–90 mmHg,
- •Heart rate (HR) 40–100 bpm.
- •5\.At screening, and pre\-inoculation: QTcF less than or equal to 450 msec (male volunteers); QTcF less than or equal to 470 msec (female volunteers); PR interval less than or equal to 210 msec for both males and females.
- •6\. Women of childbearing potential (WOCBP) who anticipate being sexually active with a male during the trial must agree to use a highly effective method of birth control combined with a barrier contraceptive from the screening visit until 30 days after the end of study (covering a full menstrual cycle) and have a negative urine pregnancy test result prior to inoculation with the malaria challenge agent on Day 0\.
Exclusion Criteria
- •1\.Known hypersensitivity to artesunate or other artemisinin derivatives, lumefantrine, proguanil/atovaquone, primaquine, or 4\-aminoquinolines.
- •2\.Any history of anaphylaxis or other severe allergic reactions, or other food or drug allergy that the Investigator considers may impact on participant safety.
- •3\.History of convulsion (including drug or vaccine\-induced episodes). A medical history of febrile convulsion during childhood (less than 5 years) is not an exclusion criterion.
- •4\.Presence of current or suspected uncontrolled chronic diseases that may impact participant safety or interpretation of clinical trial results, such as (but not limited to) cardiac or autoimmune disease, diabetes, progressive neurological disease, severe malnutrition, hepatic or renal disease, epilepsy, or asthma.
- •5\.History of malignancy of any organ system (other than localised basal or squamous cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within five years of screening, regardless of whether there is no evidence of local recurrence or metastases.
- •6\.Individuals with history of schizophrenia, bipolar disorder psychoses, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis including generalised anxiety disorder.
- •7\.History of an episode of depression lasting more than 6 months that required pharmacological therapy and/or psychotherapy within the last 2 years.
- •8\.A score of 20 or more on the Beck Depression Inventory\-II (BDI\-II) and/or a response of 1, 2 or 3 for item 9 of this inventory (related to suicidal ideation).
- •The BDI\-II will be used as a validated tool for the assessment of depression at screening. Participants that meet criterion 8 will be referred to a general practitioner or medical specialist as appropriate. Participants with a BDI\-II score of 17 to 19 may be enrolled at the discretion of the Investigator if they do not have a history of the psychiatric conditions mentioned in criterion 6 and their mental state is not considered to pose additional risk to the health of the participant during the trial or to the execution of the trial and interpretation of the data gathered.
- •9\.History of splenectomy.
Outcomes
Primary Outcomes
Not specified
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