Malaria Plasmodium falciparum
Conditions
Interventions
Intervention per group:
Stage A
1. Once infection with 1.35x10^5 PfSPZ-GA1
2. Once infection with 4.5x10^5 PfSPZ-GA1
3. Once infection with 9.0x10^5 PfSPZ-GA1
Stage B
4. 3 immunisations with 9.0x10^5
Sponsors
Sanaria
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is aged * 18 and * 35 years and in good health. 2. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby. 3. Subject is able to communicate well with the investigator, is available to attend all study visits. 4. Furthermore the subject will remain within the Netherlands from day -1 till day +28 after each parasite exposure and be reachable by phone (24/7). From day 28 till day 35 after each infection subjects have to be reachable by phone (24/7) throughout this study period. 5. Subject agrees to inform his/her general practitioner about participation in the study and to sign a request to release by the GP, and medical specialist when necessary, any relevant medical information concerning possible contra-indications for participation in the study. 6. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to current Sanquin guidelines (3 years minimum, depending on serology). 7. Non-pregnant, non-lactating females of reproductive potential (i.e., have a uterus and are neither surgically sterilized nor post-menopausal) should agree to use adequate contraception and not to breastfeed for the duration of study. 8. Subject agrees to refrain from intensive physical exercise (disproportionate to the subjects* usual daily activity or exercise routine) for twenty-one days following each immunization and during the malaria challenge period. 9. Subject has signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immune-deficient, psychiatric or other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following: 1.1 Body weight 30.0 kg/m2 at screening 1.2 A heightened risk of cardiovascular disease, defined as: an estimated ten year risk of fatal cardiovascular disease of *5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia*s, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in first or second degree relatives (according to the system used in medical genetics)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GA1 stage A: Primary endpoints: * Presence of blood stage parasites after inoculation with PfSPZ-GA1 as assessed by qPCR * Frequency and magnitude of adverse events in study groups GA1 stage B: Primary endpoints: * Frequency and magnitude of adverse events in study groups | — |
Secondary
| Measure | Time frame |
|---|---|
| GA1 stage B: * Presence of parasitemia after controlled human malaria infection with the wild-type NF54 strain, as detected by qPCR | — |
Countries
Netherlands
Outcome results
None listed