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Trial registered on ANZCTR


Registration number
ACTRN12612000824864
Ethics application status
Approved
Date submitted
1/08/2012
Date registered
6/08/2012
Date last updated
17/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
An experimental study to characterize the in vivo infectivity of the Plasmodium falciparum isolate HMP02Pf in healthy human volunteers.
Scientific title
An experimental study to characterize the in vivo infectivity of the Plasmodium falciparum isolate HMP02Pf in healthy human volunteers.
Secondary ID [1] 280929 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 287020 0
Condition category
Condition code
Infection 287350 287350 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Phase I clinical trial to study the safety and infectivity of a wild type Plasmodium falciparum isolate by experimental inoculation with blood stage parasites in healthy volunteers. The dose will be 1800 Plasmodium falciparum parasites administered as a single intravenous infusion.
Intervention code [1] 285362 0
Treatment: Drugs
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287615 0
To characterize the in vivo infectivity of P. falciparum isolate HMP02Pf in healthy volunteers following infection with blood stage parasites. This outcome will be assessed by measuring the levels of P. falciparum deoxyribonucleic acid (DNA) by quantitative real time polymerase chain reaction (qPCR).
Timepoint [1] 287615 0
90 days
Secondary outcome [1] 298534 0
To confirm the parasite growth curves after intravenous inoculation of healthy volunteers with naturally acquired P. falciparum blood stage parasites. This outcome will be assessed by comparison with data from previous studies.
Timepoint [1] 298534 0
14 days
Secondary outcome [2] 298535 0
To establish the parasite clearance profiles after administration of antimalarial drug at a target parasitemia of greater than or eaqual to 1,000 parasites/mL after experimental inoculation of parasites. This outcome will be assessed by measuring the levels of P. falciparum deoxyribonucleic acid (DNA) by quantitative real time polymerase chain reaction (qPCR).
Timepoint [2] 298535 0
14 days
Secondary outcome [3] 298536 0
To assess the safety of an experimental malaria challenge using naturally occurring parasites. This outcome will be assessed by soliciting unexpected adverse events and by assessing volunteers for seroconversion to adventitious agents.
Timepoint [3] 298536 0
90 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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).
11) Evidence of acute illness within the four weeks before trial prior to screening.
12) Significant intercurrent disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis.
13) Have ever received a blood transfusion.
14) Evidence of any condition that, in the opinion of the clinical investigator, might interfere with the evaluation of the study objectives or pose excessive risks to participants.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285709 0
Self funded/Unfunded
Name [1] 285709 0
Dr James McCarthy
Country [1] 285709 0
Australia
Primary sponsor type
Other
Name
The Queensland Institute of Medical Research
Address
300 Herston Rd
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 284539 0
None
Name [1] 284539 0
Address [1] 284539 0
Country [1] 284539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287716 0
The Queensland Institute of Medical Research Human Research Ethics Committee
Ethics committee address [1] 287716 0
The Queensland Institute of Medical Research,
Post Office Royal Brisbane,QLD, 4029
Ethics committee country [1] 287716 0
Australia
Date submitted for ethics approval [1] 287716 0
21/05/2012
Approval date [1] 287716 0
27/07/2012
Ethics approval number [1] 287716 0
P1461

Summary
Brief summary
This is a pilot study of safety and infectivity in 2 healthy volunteers of a new Plasmodium falciparun Malaria bank (HMP02Pf) obtained from an malaria infected patient under HREC approval from both Royal Brisbane and Women’s Hospital and Queensland Institute of Medical Research. The Malaria bank was prepared under highly controlled conditions using protocols developed in conjunction with the Red Cross the US FDA and QGen. The clinical protocol is based on prior studies using the 3D7 Plasmodium falciparum isolate. The malaria bank has had full serological and PCR evaluations over 6 months meeting the criteria of ARCBS blood donation requirements. This study is to establish the safety and comparative growth kinetics of the other 3D7 malaria inoculum. The antimalarial agent used to treat the malaria is the TGA approved Riamet, which was also used to eradicated the malaria infection in the patient donor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34498 0
Dr James McCarthy
Address 34498 0
300 Herston Road
Herston
Brisbane, QLD 4006
Country 34498 0
Australia
Phone 34498 0
+61 738453796
Fax 34498 0
+61 733620104
Email 34498 0
[email protected]
Contact person for public queries
Name 17745 0
Silvana Sekuloski
Address 17745 0
Queensland Insitute of Medical Research
300 Herston Rd
Herston QLD 4006
Australia
Country 17745 0
Australia
Phone 17745 0
+61738453856
Fax 17745 0
+61738453507
Email 17745 0
[email protected]
Contact person for scientific queries
Name 8673 0
James McCarthy
Address 8673 0
Queensland Insitute of Medical Research
300 Herston Rd
Herston QLD 4006
Australia
Country 8673 0
Australia
Phone 8673 0
+61733620222
Fax 8673 0
+61738453637
Email 8673 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIInfectivity of Plasmodium falciparum in Malaria-Naive Individuals Is Related to Knob Expression and Cytoadherence of the Parasite2016https://doi.org/10.1128/iai.00414-16
EmbaseHuman challenge models: tools to accelerate the development of malaria vaccines.2019https://dx.doi.org/10.1080/14760584.2019.1580577
N.B. These documents automatically identified may not have been verified by the study sponsor.