Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000615785
Ethics application status
Approved
Date submitted
28/05/2013
Date registered
29/05/2013
Date last updated
20/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Dose ranging study to examine the infectivity of the Plasmodium falciparum NF54 cell bank MCB-002 in healthy adult males
Scientific title
In vivo dose ranging study to characterise the infectivity of the Plasmodium falciparum NF54 cell bank MCB-002 in malaria naive humans
Secondary ID [1] 282580 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 289271 0
Condition category
Condition code
Infection 289596 289596 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Human red blood cells infected with Plasmodium falciparum NF54
Dose: 30,000 viable Plasmodium falciparum infected red blood cells. Dose is determined using a calculation based on the number of parasite positive cells and viability of parasites in the cell bank (as previously determined by limiting dilution assay).
Mode of administration: Intravenous injection
Duration: one injection at Study Day 0 for each volunteer
Patients will be actively monitored up until Day 28 post injection. A blood sample will be collected on Day 90 post infection for safety serum.
Intervention code [1] 287246 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289685 0
Primary Outcome 1: The in vivo infectivity of different doses of the P. falciparum NF54 cell bank, MCB-002 in humans.
Assessed by thick blood film and polymerase chain reaction
Timepoint [1] 289685 0
Day 1- Day 14 post administration of P. falciparum infected red blood cells.
Primary outcome [2] 289686 0
Primary Outcome 2: Safety of different doses of the P. falciparum NF54 cell bank, MCB-002 in humans.
Assessed by frequency and type of clinical adverse events, hematology, blood chemistry, serology, physical examination including vital signs and electrocardiograms.
Timepoint [2] 289686 0
Day 0-Day 90 post administration of the P. falciparum NF54 cell bank MCB-002 in humans.
Secondary outcome [1] 303011 0
Secondary OUtcome 1: Immunogenicity of the P. falciparum NF54 cell bank MCB-002 in humans.
Assessed by measuring malaria specific antibody responses and T cell responses
Timepoint [1] 303011 0
D0, D14, D28 and D90.

Eligibility
Key inclusion criteria
1. Males aged 18-45 years who do not live alone from D1 until at least the end of anti-malarial treatment.
2. Body Mass Index within range of 18-30
3. Contactable and available for the duration of the trial (90 days).
4. Non-smokers and in good health as assessed during pre-study medical examination and by review of screening results.
5. Good peripheral venous access.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of clinical malaria.
2. Travelled to or lived (>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 >10%, 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. History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination, infusion or treatment with the anti-malarial drugs artemether and/or lumefantrine.
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. Individuals wishing to donate blood to the Australian Red Cross Blood Service during the study or within 6 months of administration of the malaria inoculum.
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. Known pre-existing prolongation of the QTc interval. Family history of congenital prolongation of the QTc interval on electrocardiograms or of sudden death or any other clinical condition known to prolong the QTc interval, e.g. volunteers with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
11. Recent or current therapy with an antibiotic or drug with potential anti-malarial activity (tetracycline, azthromycin, clindamycin, hydroxychloroquine etc).
12. Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine) OR drugs that are known to prolong the QTc interval, e.g. antiarrhythmics of classes IA and III, neuroleptics, antidepressant agents, certain antibiotics (including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents), certain nonsedating antihistamines (terfenadine, astemizole), cisapride.
13. Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants. Currently receiving or have previously received immunosuppressive therapy, including systemic steroids including ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression such as 1mg/kg/day of prednisone or its equivalent or chronic use of inhaled high potency corticosteroids (budesonide 800 micrograms per day or fluticasone 750 micrograms).
14. Presence of acute infectious disease or fever (e.g., sub-lingual temperature greater than or equal to 38.5 degrees celsius) within the five days prior to study product administration).
15. Evidence of acute illness within the four weeks before trial prior to screening.
16. 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.
17. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
18. A history of drug habituation, or any prior intravenous usage of an illicit substance.
19. Medical requirement for intravenous immunoglobulin or blood transfusions.
20. Participation in any research study involving significant blood sampling, or blood donation to Red Cross (or other) blood bank during the 8 weeks preceding administration of the IP in the study.
21. Have ever received a blood transfusion.
22. Positive test for HIV, Hepatitis B, hepatitis C, Human T-cell Lymphotropic Virus I & II (HTLVI & HTLVII), TB or syphilis.
23. Any clinically significant biochemical or haematologic abnormality (Hb must be greater than or equal to 13.5g/dL).
24. Ingestion of any poppy seeds within the 48 hours prior to the screening blood test
(volunteers will be advised by phone not to consume any poppy seed in this time period).
25. Detection of any drug in the urine drug screen unless there is an explanation acceptable to the medical investigator (e.g. the subject has stated in advance that they consumed a prescription or OTC product which contained the detected drug) and/or the subject has a negative urine drug screen on retest by the pathology laboratory. These drugs include: Amphetamines, Methamphetamines, Barbituates, Benzodiazepines, Cocaine, Methadone, Opiates, Phencyclidine, Tetrahydrocannabinols and Tricyclic anti-depressants.
26. 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. (this criterion is complete)

Although not exclusion criteria, volunteers will be asked to answer the following criterion:
27. Participation in any investigational product study within the 8 weeks preceding the study.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/06/2013
Actual
5/08/2013
Date of last participant enrolment
Anticipated
Actual
27/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
2
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287360 0
Charities/Societies/Foundations
Name [1] 287360 0
The Atlantic Philanthropies
Country [1] 287360 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
c/- Chris Davis
Griffith University, Gold Coast Campus
Institute for Glycomics, Building G26
Parklands Drive
Southport, 4222
QLD
Country
Australia
Secondary sponsor category [1] 286107 0
None
Name [1] 286107 0
Address [1] 286107 0
Country [1] 286107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289336 0
The Gold Coast Hospital and Health Services Human Research Ethics Committee
Ethics committee address [1] 289336 0
Ethics committee country [1] 289336 0
Australia
Date submitted for ethics approval [1] 289336 0
Approval date [1] 289336 0
15/04/2013
Ethics approval number [1] 289336 0
HREC/13/QGC/22
Ethics committee name [2] 289337 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 289337 0
Ethics committee country [2] 289337 0
Australia
Date submitted for ethics approval [2] 289337 0
Approval date [2] 289337 0
06/05/2013
Ethics approval number [2] 289337 0
GLY/03/13/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34877 0
Prof Michael Good
Address 34877 0
c/- Griffith University, Gold Coast Campus
Institute for Glycomics, building G26
Parklands Drive, Southport, 4222 QLD
Country 34877 0
Australia
Phone 34877 0
61 7 555 28051
Fax 34877 0
61 7 555 28098
Email 34877 0
[email protected]
Contact person for public queries
Name 18124 0
Danielle Stanisic
Address 18124 0
c/- Griffith University, Gold Coast Campus
Institute for Glycomics, building G26
Parklands Drive, Southport, 4222 QLD
Country 18124 0
Australia
Phone 18124 0
61 7 555 28051
Fax 18124 0
61 7 555 28098
Email 18124 0
[email protected]
Contact person for scientific queries
Name 9052 0
Michael Good
Address 9052 0
c/- Griffith University, Gold Coast Campus
Institute for Glycomics, building G26
Parklands Drive, Southport, 4222 QLD
Country 9052 0
Australia
Phone 9052 0
61 7 555 28051
Fax 9052 0
61 7 555 28098
Email 9052 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
N.B. These documents automatically identified may not have been verified by the study sponsor.