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Trial registered on ANZCTR


Registration number
ACTRN12613000669796
Ethics application status
Approved
Date submitted
12/06/2013
Date registered
19/06/2013
Date last updated
15/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An Experimental Study To Characterise the in vivo Infectivity in Humans of the in vitro Expanded Blood Stage Plasmodium Falciparum Line QIMR3D7Pf
Scientific title
An Experimental Study To Characterise the in vivo Infectivity in Humans of the in vitro Expanded Blood Stage Plasmodium Falciparum Line QIMR3D7Pf
Secondary ID [1] 282660 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 289361 0
Condition category
Condition code
Infection 289697 289697 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-centre, study using blood stage malaria infected red blood cells inoculum challenge in order to characterize the infectivity of the in vitro expanded Plasmodium falciparum QIMR3D7Pf in healthy volunteers. The study will be conducted in 2 individuals. Each participant in the cohort will be inoculated on Day 0 with ~1,800 viable Plasmodium falciparum-in vitro infected human erythrocytes administered intravenously. On an outpatient basis, participants will be monitored daily prior to detection of parasites or morning (AM) and evening (PM) (once PCR positive for presence of malaria parasites) from day 3 to day 7 for adverse events and the unexpected early onset of symptoms, signs or parasitological evidence of malaria. On the day designated for commencement of treatment, as determined by qPCR results (expected to be Day 7), participants will be admitted to the study unit and confined for safety monitoring and antimalarial treatment. The threshold for commencement of treatment will be when PCR quantification is confirmed to be approximately =1,000 parasites/mL when the participants will be administered antimalarial treatment. If clinical evidence of malaria (the onset of clinical features of malaria) occurs or PCR quantification of =1,000 parasites/mL is detected before day 7 morning, allocated treatment will begin at this time. Following treatment, participants will be followed up as inpatients for at least 36 hours, to ensure tolerance of the therapy and clinical response, then if clinically well on an outpatient basis for monitoring of, safety and clearance of malaria parasites via PCR.
Intervention code [1] 287326 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289790 0
To characterize the in vivo infectivity of QIMR3D7Pf in healthy volunteers, following infection with in vitro expanded blood stage P. falciparum parasites.
This outcome is assessed though regular PCR blood tests
Timepoint [1] 289790 0
Timepoints day 5- day 28
Secondary outcome [1] 303245 0
To confirm the parasite growth curves after I.V. inoculation of healthy volunteers with in vitro expanded blood stage P. falciparum strain 3D7 malaria parasites; This outcome is assessed though regular PCR blood tests
Timepoint [1] 303245 0
Timepoints day 5- day 28
Secondary outcome [2] 303246 0
To establish the parasite clearance profiles by PCR after administration of antimalarial drug at a target parasitemia of =1,000 parasites/mL after inoculation with an experimental malaria challenge; This outcome is assessed though regular PCR blood tests
Timepoint [2] 303246 0
Timepoints day 5- day 28
Secondary outcome [3] 303247 0
To assess the safety of an experimental malaria challenge using in vitro expanded blood stage parasites. This outcome is assessed though clinical assessment (history, vital signs, and physical examination), as well as urinalysis, haematology biochemistry and red cell alloantibody evaluation
Timepoint [3] 303247 0
Timepoint 90 DAYS

Eligibility
Key inclusion criteria
1. Participants 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. Participants must have a BMI within the range 18–30 kg/m2.
3. Participants 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. Participants 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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of malaria or tavelled to or lived (greater than 2 weeks) in a malaria-endemic country during the past 12 months
2. Has evidence of increased cardiovascular disease risk
3. History of splenectomy.
4. History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
5. Presence of current or suspected serious chronic diseases or significant intercurrent disease of any type
6. Unwilling to defer blood donations for 6 months.
7. Recent or current therapy with an antibiotic or drug with potential antimalarial activity (tetracycline, azthromycin, clindamycin, hydroxychloroquine etc.).
8. Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D6
9. Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants.
10. Presence of acute infectious disease or fever
15. Evidence of acute illness within the four weeks before trial prior to screening.
11. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
12. A history of drug habituation, or any prior intravenous usage of an illicit substance.
13. Medical requirement for intravenous immunoglobulin or blood transfusions.
14. Participation in any investigational product study within the 8 weeks preceding the study.
15. Any clinically significant biochemical or haematologic abnormality
16. Vital signs outside the reference range and clinically significant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive statistical analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287443 0
Self funded/Unfunded
Name [1] 287443 0
Address [1] 287443 0
Country [1] 287443 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Queensland Institute of Medical Research
Address
300 Herston Road, Herston, Brisbane, QLD, 4006
Country
Australia
Secondary sponsor category [1] 286186 0
None
Name [1] 286186 0
Address [1] 286186 0
Country [1] 286186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289417 0
The Queensland Institute of Medical Research
Ethics committee address [1] 289417 0
The Queensland Institute of Medical Research HREC,
QIMR Central, 300 Herston Road, HERSTON, QLD, 4006
Ethics committee country [1] 289417 0
Australia
Date submitted for ethics approval [1] 289417 0
Approval date [1] 289417 0
03/05/2013
Ethics approval number [1] 289417 0
P1528

Summary
Brief summary
This is a single-centre study using a QIMR3D7Pf innoculum challenge to assess the infectivity of this recently collected isolate. The study will be a first in human study conducted in 2 participants. A sentinel volunteer will be dosed 24 h ahead of the remaining volunteer.
Trial website
Trial related presentations / publications
none to date
Public notes

Contacts
Principal investigator
Name 40718 0
Dr James McCarthy
Address 40718 0
Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Australia
Country 40718 0
Australia
Phone 40718 0
+61 7 33620222
Fax 40718 0
+61 7 3845 3637
Email 40718 0
j.mccarthy@uq.edu.au
Contact person for public queries
Name 40719 0
Dr Silvana Sekuloski
Address 40719 0
Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Australia
Country 40719 0
Australia
Phone 40719 0
+61 7 38453856
Fax 40719 0
+61 7 38453507
Email 40719 0
Silvana.Sekuloski@qimr.edu.au
Contact person for scientific queries
Name 40720 0
Dr James McCarthy
Address 40720 0
Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Australia
Country 40720 0
Australia
Phone 40720 0
+61 7 33620222
Fax 40720 0
+61 7 3845 3637
Email 40720 0
j.mccarthy@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary