Malaria infectie Plasmodium falciparum
Conditions
Interventions
1. CPS immunization
On the first day of the study, all study subjects of cohort A will be seen by
the investigators to initiate mefloquine prophylaxis. All volunteers will
receive 250mg mefloquine
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 significant 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and magnitude of adverse events after NF135.C10 CPS immunization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints • Time to blood stage parasitemia detectable by qPCR after malaria challenge infection • Sterile protection after controlled human malaria infection Exploratory study endpoints • The phenoptype and cytokine profile of P. falciparum specific T cell responses induced by NF135.C10 CPS immunization • The antigen specificity of T cell responses induced by NF135.C10 CPS immunization • The antigen specificity and/or functionality of P. falciparum specific antibodies induced by NF135.C10 CPS immunization • The phenotype and/or function of innate and semi-innate immune responses to NF135.C10 CPS immunization and/or CHMI, including γδT cells, invariant T cells, antigen presenting cells, NK cells and granulocytes • Epigenetic profiles of innate immune cell subsets, with emphasis on both activation (H3K4me3, H3K4me1, H3K27Ac) and repression (H3K9me3, H3K27me) markers • RNA transcriptome profiling through whole mRNA-sequencing, PCR and/or microarray | — |
Countries
Netherlands
Outcome results
None listed