Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000618752
Ethics application status
Approved
Date submitted
28/05/2013
Date registered
29/05/2013
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Safety and Tolerability Study in healthy adult males for Tafuramycin-A attenuated Plasmodium falciparum NF54 blood stage parasites.
Scientific title
A Safety and Tolerability Study in malaria naive humans for Tafuramycin-A attenuated Plasmodium falciparum NF54 blood stage parasites.
Secondary ID [1] 282583 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 289274 0
Condition category
Condition code
Infection 289599 289599 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single inoculation of 3 x 10^7 tafuramycin-A attenuated Plasmodium falciparum NF54 blood stage parasites contained within human red blood cells.
Mode of administration: Intra-venous injection.
Duration: One injection on the volunteers' study Day 0.
Patients will be actively monitored for up to Day 28 post injection. A blood sample will be collected on Day 90 post injection for safety serum.
Intervention code [1] 287249 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289690 0
1. To assess the safety and tolerability of tafuramycin-A attenuated P. falciparum NF54 blood stage parasites in humans.

This will be assessed by:
-monitoring the occurrence, severity and duration of inoculum-related solicited symptoms during the study period.
-monitoring the occurrence, severity and duration of inoculum-related unsolicited symptoms, abnormal physical findings and abnormal laboratory values during the study period.
-monitoring the occurrence, severity and duration of inoculum-related serious adverse events during the study period.
Timepoint [1] 289690 0
Day 0-Day 90 post administration of the tafuramycin-A attenuated P. falciparum NF54 blood stage parasites.
Secondary outcome [1] 303018 0
To examine the immunogenicity of Tafuramycin-A attenuated P. falciparum NF54 blood stage parasites in humans.

This will be assessed by measuring antibody and T cell responses against whole P. falciparum NF54 parasite antigen and P. falciparum derived antigens during the study period.
Timepoint [1] 303018 0
D0, D2, 4, 6, 8, 10, 12, 14, 15, 16, 28 and 90.

Eligibility
Key inclusion criteria
1. Males aged 18-60 years of age who do not live alone for the duration of the study.
2. Body mass index within range 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 vein access.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Has increased cardiovascular disease risk (defined as >10%, 5 yr risk) as determined by the method of Gaziano et al. Risk factors include: sex, age, systolic blood pressure, smoking status, body mass index (BMI, kg/mm2), and reported diabetes status and blood pressure.
2. History of splenectomy
3. History of severe allergic reaction, anaphylaxis or convulsion following any vaccination, infusion or treatment with anti-malarial drugs artemether and/or lumefantrine.
4. Presence of current or suspected 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, obsessive compulsive disorder, skin carcinoma excluding non-spreadable skin cancers such as basal cell and squamous cell carcinoma.
5. Known inherited genetic anomaly (known as cytogenic disorders) eg Down’s syndrome.
6. Individuals wishing to donate blood to the Australian Red Cross Blood Service in the future.
7. The volunteer has a diagnosis of schizophrenia, bi-polar disease, severe depression or other severe (disabling) chronic psychiatric disorder. Participants who are receiving a single anti-depressant 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.
8. Has been hospitalised in the past 5 years prior to enrolment for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
9. 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 conditions known to prolong the QTc interval eg volunteers with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
10. Recent or current therapy with antibiotic or drug with potential antimalarial activity (tetracycline, azithromycin, clindamycin, hydroxychloroquine etc).
11. Concomitant use of any drug which is metabolized by the cytochrome enzyme CYP2D6 (eg 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.
12. 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 axis suppression such as 1mg/kg/day or prednisone or its equivalent or chronic use of inhaled high potency corticosteroids (budesonide 800 micrograms per day or fluticasone 750 micrograms).
13. 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 the study product administration.
14. Evidence of acute illness within the 4 weeks before trial prior to screening.
15. 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.
16. Alcohol consumption greater than community norms (ie more than 21 standard drinks per week for males).
17. A history of drug habituation, or any prior intravenous usage of an illicit substance.
18. Medical requirement for intravenous administration of immunoglobulin or blood transfusions.
19. Participation in any investigational product study within 8 weeks preceding the study.
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 the study.
21. Have ever received a blood transfusion.
22. Positive test for HIV, Hepatitis B, Hepatitis C, Human T-cell Lymphotropic Virus I and II(HTLV I and II), 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 seeds in this time period).
25. Detection of any drug in the urine drug screen unless there is an explanation acceptable to the medical investigator (eg 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 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
27. G-6-PD deficiency

Although not exclusion criteria, volunteers will be asked to answer the following questions to enable interpretation and analysis of immunogenicity data:
28. History of malaria
29. Travelled to or lived (>2 weeks) in a malaria-endemic country during the past 12 months or planned to travel to a malaria-endemic country during the course of 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
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287363 0
Charities/Societies/Foundations
Name [1] 287363 0
The Atlantic Philanthropies
Country [1] 287363 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] 286110 0
None
Name [1] 286110 0
Address [1] 286110 0
Country [1] 286110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289339 0
Gold Coast Hospital and Health Services Human Research Ethics Committee
Ethics committee address [1] 289339 0
Ethics committee country [1] 289339 0
Australia
Date submitted for ethics approval [1] 289339 0
Approval date [1] 289339 0
13/03/2013
Ethics approval number [1] 289339 0
HREC/12/QGC/173
Ethics committee name [2] 289340 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 289340 0
Ethics committee country [2] 289340 0
Australia
Date submitted for ethics approval [2] 289340 0
Approval date [2] 289340 0
06/05/2013
Ethics approval number [2] 289340 0
GLY/04/13/HREC

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

Contacts
Principal investigator
Name 40350 0
Dr Danielle Stanisic
Address 40350 0
c/- Griffith University
Gold Coast Campus
Institute for Glycomics, Building G26
Parklands Drive
Southport, 4222 QLD
Country 40350 0
Australia
Phone 40350 0
+61 7 555 28051
Fax 40350 0
+61 7 555 28098
Email 40350 0
[email protected]
Contact person for public queries
Name 40351 0
Danielle Stanisic
Address 40351 0
c/- Griffith University
Gold Coast Campus
Institute for Glycomics, Building G26
Parklands Drive
Southport, 4222 QLD
Country 40351 0
Australia
Phone 40351 0
+61 7 555 28051
Fax 40351 0
+61 7 555 28098
Email 40351 0
[email protected]
Contact person for scientific queries
Name 40352 0
Danielle Stanisic
Address 40352 0
c/- Griffith University
Gold Coast Campus
Institute for Glycomics, Building G26
Parklands Drive
Southport, 4222 QLD
Country 40352 0
Australia
Phone 40352 0
+61 7 555 28051
Fax 40352 0
+61 7 555 28098
Email 40352 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
No additional documents have been identified.