Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12612001096842
Ethics application status
Approved
Date submitted
9/10/2012
Date registered
15/10/2012
Date last updated
10/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
An experimental study to characterize the in vivo safety and infectivity of the Plasmodium vivax isolate HMPBS-Pv in humans (QP12C14)
Query!
Scientific title
An experimental study to characterize the in vivo safety and infectivity of the Plasmodium vivax isolate HMPBS-Pv in humans (QP12C14)
Query!
Secondary ID [1]
281276
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Malaria
287472
0
Query!
Condition category
Condition code
Infection
287805
287805
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
This is a Phase I clinical trial to study the safety and infectivity of the Plasmodium vivax isolate by experimental inoculation with blood stage parasites in healthy volunteers. The dose will be 1800 Plasmodium vivax parasites administered as a single intravenous infusion.
Query!
Intervention code [1]
285745
0
Treatment: Other
Query!
Comparator / control treatment
No treatment
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
288028
0
To determine the safety of an experimental malaria challenge using naturally occurring parasites. This outcome will be assessed by measuring clinical and laboratory safety parameters.Clinical safety will be assessed by soliciting symptoms and signs of malaria and of adverse effects of the inoculum. Laboratory safety parameters will include standard haematologic and biochemical tests as well as serologic evidnece of seroconversion to adventitious agents.Solicited adverse events will include immediate allergic/hypersensitivity reactions to the inoculum as well as evidence of unexpected infection with adventitious agents
Query!
Assessment method [1]
288028
0
Query!
Timepoint [1]
288028
0
90 days
Query!
Primary outcome [2]
288029
0
To characterize the in vivo infectivity of P. vivax isolate HMPBS-Pv in healthy volunteers following infection with blood stage parasites. This outcome will be assessed by measuring the levels of P. vivax deoxyribonucleic acid (DNA) by quantitative real time polymerase chain reaction (qPCR).
Query!
Assessment method [2]
288029
0
Query!
Timepoint [2]
288029
0
14 days
Query!
Secondary outcome [1]
299304
0
To define the parasite growth curves after I.V. inoculation of healthy volunteers with naturally acquired P. vivax blood stage parasites This outcome will be assessed by correlation with blood smear data.
Query!
Assessment method [1]
299304
0
Query!
Timepoint [1]
299304
0
14 days
Query!
Secondary outcome [2]
299305
0
To explore the parasite clearance profiles by PCR after administration of antimalarial drug at a target parasitemia of greater than or equal to 1,000 parasites/mL after inoculation with an experimental malaria challenge.
This outcome will be assessed by measuring the levels of P. vivax deoxyribonucleic acid (DNA) by quantitative real time polymerase chain reaction (qPCR).
Query!
Assessment method [2]
299305
0
Query!
Timepoint [2]
299305
0
14 days
Query!
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. Adequate contraception to be in place for female and male volunteers and for females to 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
45
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
1) History of malaria.
2) Travelled to or lived for more than 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 greater than 10 percent, 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) Pregnant or breast feeding (all women will have a negative pregnancy test result prior to each study product administered).
6) History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
7)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.
8) Known inherited genetic anomaly (known as cytogenetic disorders) e.g., Down’s syndrome
9) Volunteers unwilling to defer blood donations to the ARCBS for 6 months.
10) 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 enrolment without decompensating may be allowed to enrol in the study at the investigator’s discretion.
11) Presence of acute infectious disease or fever (e.g., sub-lingual temperature greater than or equal to 38.5 degrees Celcius) within the five days prior to study product administration).
12) Evidence of acute illness within the four weeks before trial prior to screening.
13) 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.
14) Have ever received a blood transfusion.
15) 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
10/10/2012
Query!
Actual
25/10/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
24/01/2013
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
2
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
286039
0
Self funded/Unfunded
Query!
Name [1]
286039
0
Dr James McCarthy
Query!
Address [1]
286039
0
300 Herston Rd
Herston QLD 4029
Query!
Country [1]
286039
0
Australia
Query!
Primary sponsor type
Other
Query!
Name
The Queensland Institute of Medical Research
Query!
Address
300 Herston Rd
Herston QLD 4029
Query!
Country
Australia
Query!
Secondary sponsor category [1]
284853
0
None
Query!
Name [1]
284853
0
Query!
Address [1]
284853
0
Query!
Country [1]
284853
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
288086
0
Queensland Institute of Medical Research Human Research Ethics Committee
Query!
Ethics committee address [1]
288086
0
The Queensland Institute of Medical Research
QIMR Locked Bag 2000
Royal Brisbane,QLD, 4029
Query!
Ethics committee country [1]
288086
0
Australia
Query!
Date submitted for ethics approval [1]
288086
0
30/08/2012
Query!
Approval date [1]
288086
0
09/10/2012
Query!
Ethics approval number [1]
288086
0
P1478
Query!
Summary
Brief summary
This is a pilot study of safety and infectivity in 2 healthy volunteers of a new Plasmodium vivax Malaria bank obtained from a 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. 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.
Query!
Trial website
Query!
Trial related presentations / publications
James S. McCarthy, Paul M. Griffin, Silvana Sekuloski, A. Taylor Bright, Rebecca Rockett, David Looke, Suzanne Elliott, David Whiley, Theo Sloots, Elizabeth A. Winzeler, and Katherine R. Trenholme. "Experimentally Induced Blood-Stage Plasmodium vivax Infection in Healthy Volunteers." Journal of Infectious Disease 208.10 (2013): 1688-1694.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
34742
0
Dr James McCarthy
Query!
Address
34742
0
Queensland Institute of Medical Research 300 Herston Rd Herston QLD 4006
Query!
Country
34742
0
Australia
Query!
Phone
34742
0
+61 7 33620222
Query!
Fax
34742
0
Query!
Email
34742
0
[email protected]
Query!
Contact person for public queries
Name
17989
0
Dr Silvana Sekuloski
Query!
Address
17989
0
Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Query!
Country
17989
0
Australia
Query!
Phone
17989
0
+61 7 38453856
Query!
Fax
17989
0
+61 7 38453507
Query!
Email
17989
0
[email protected]
Query!
Contact person for scientific queries
Name
8917
0
Dr Dr James McCarthy
Query!
Address
8917
0
Queensland Institute of Medical Research
300 Herston Rd
Herston QLD 4006
Query!
Country
8917
0
Australia
Query!
Phone
8917
0
+61 7 33620222
Query!
Fax
8917
0
+61 7 3845 3637
Query!
Email
8917
0
[email protected]
Query!
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
Source
Title
Year of Publication
DOI
Embase
Experimentally induced blood-stage plasmodium vivax infection in healthy volunteers.
2013
https://dx.doi.org/10.1093/infdis/jit394
Dimensions AI
Plasmodium vivax but Not Plasmodium falciparum Blood-Stage Infection in Humans Is Associated with the Expansion of a CD8+ T Cell Population with Cytotoxic Potential
2016
https://doi.org/10.1371/journal.pntd.0005031
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF