Plasmodium falciparum
Conditions
Interventions
BCG vaccination (BCG Vaccine, BB-NCIPD, Ltd, Sofia, Bulgaria)
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is aged >=18 and
Exclusion criteria
Exclusion criteria: 1.Any history, or evidence at screening, of clinically signifìcant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and 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 kg/m2 at screening. 1.2 A heightened risk of cardiovascular disease, as determined by: 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 1st or 2nd degree relatives <50 years old. 1.3 A medical history of functional asplenia, sickle cell traildisease, thalassaemia trait/disease or G6PD defìciency. 1.4 History of epilepsy in the period of five years prior to study onset, even if no longer on medication. 1.5 Screening tests positive for Human lmmunodeficiency Virus (HlV), or active Hepatitis B Virus (HBS) or Hepatitis C Virus (HCV). 1.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifuing drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period. 1.7 Use of Non-steroidal Anti-lnflammatory Drugs (NSAlDs) in the four weeks prior to study start or expected use of NSAIDS during the study period. 1.8 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years. 1.9 Any history of treatment for severe psychiatric disease by a psychiatrist in the past year. 1.10 History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening or prior to infection, or positive urine toxicology test for cannabis at inclusion. 2. For female subjects: positive urine pregnancy test at screening or at inclusion. 3. Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria (vaccine) study. 4. Known hypersensitivity to or contra-indications (including co-medication) for use of chloroquine, Malarone or artemether-lumefantrine, or history of severe (allergic) reactions to mosquito bites. 5. Receipt of any vaccinations in the 3 months prior to the start of the study or plans to receive any other vaccinations during the study period or up to 90 days thereafter. 6. Participation in any other clinical study in the 30 days prior to the start of the study or during the study period. 7. Being an employee or student of the department of Medical Microbiology of the Radboudumc or the department of lnternal Medicine. 8. Previous BCG-vaccination; history of tuberculosis or positive Mantoux test; or positive whole blood IFN-γ response to restimulation with M. tuberculosis at screening. 9. Any other condition or situation that would, in the opinion o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and magnitude of adverse events in the study groups Time to blood stage parasitemia detectable by qPCR after malaria challenge infection | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood mononuclear cell (PBMC) and/or monocyte cytokine production after restimulation ex vivo Peripheral blood plasma cytokine levels including IFN-γ, TNF-a, IL-6 and IL-1β Phenotype and distribution of circulating immune cells after CHMI, including B cells, T cells, antigen presenting cells, NK cells and granulocytes | — |
Countries
Netherlands
Outcome results
None listed