None listed
Conditions
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.
Interventions
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.
Sponsors
The Queensland Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed