ACTRN12612000824864
Completed
Phase 1
An experimental study to characterize the in vivo infectivity of the Plasmodium falciparum isolate HMP02Pf in healthy human volunteers.
The Queensland Institute of Medical Research0 sites2 target enrollmentAugust 6, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- The Queensland Institute of Medical Research
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Volunteers will be adults (males or non pregnant females), aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the antimalarial drug treatment).
- •2\. Volunteers must have a BMI within the range 18–30\.
- •3\. Volunteers must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
- •4\. Be contactable and available for the duration of the trial (maximum of 4 weeks).
- •5\. Volunteers must be non\-smokers and in good health, as assessed during pre\-study medical examination and by review of screening results.
- •6\. Female participants of childbearing potential, should be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the US FDA or TGA combined with a barrier contraceptive through completion of the study and have negative results on a serum or urine pregnancy test done before administration of study medication.
- •7\. Good peripheral venous access.
- •8\. Blood group A.
Exclusion Criteria
- •1\) History of malaria.
- •2\) Travelled to or lived (2 weeks or more) 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 greater than 10%, 5 year risk)
- •4\) History of splenectomy.
- •5\) History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
- •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\) Volunteers unwilling to defer blood donations to the ARCBS for 6 months.
- •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\) Presence of acute infectious disease or fever (e.g., sub\-lingual temperature 38\.5 degrees C) within the five days prior to study product administration).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
An experimental study to characterize the in vivo safety and infectivity of the Plasmodium vivax isolate HMPBS-Pv in humans (QP12C14)ACTRN12612001096842The Queensland Institute of Medical Research2
Completed
Phase 1
Safety of Plasmodium falciparum K13 isolate in healthy participants.Malaria infectionACTRN12617000244303QIMR Berghofer Medical Research Institute 2
Completed
Phase 1
An Experimental Study To Characterise the in vivo Infectivity in Humans of the in vitro Expanded Blood Stage Plasmodium Falciparum Line QIMR3D7PfMalariaInfection - Studies of infection and infectious agentsACTRN12613000669796Queensland Institute of Medical Research2
Completed
Phase 1
Blood stage pilot challenge study to assess the safety and the infectivity of Plasmodium malariae isolate (HMPBS-Pm) in healthy volunteersMalaria infection with P. malariae strainACTRN12617000048381QIMR Berghofer Medical Research Institute 2
Recruiting
Not Applicable
Development of an ex vivo method for evaluation of the mitochondrial functioMELASJPRN-UMIN000018993Kawasaki Medical School10