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NCT05722054
Trained and Heterologous Induced-immune Responses to Tropical Infectious Diseases
Conditions: Tropical Infectious Disease
Sex: All
Ages: 1 Year – 12 Years
Healthy volunteers: 1
Enrollment: 400
Sponsor: Centre de Recherche Médicale de Lambaréné
Summary
Validation of ex vivo immune assays that are surrogates of complex in vitro assays and animal models studies to identify the occurrence, strength, and kinetics of trained and heterologous immunity may significantly impact public health.
In this study, the investigators translate findings from systems biology approaches into contextualized in vitro and ex vivo assays in children living in settings where tropical infectious diseases are highly prevalent.
The investigators first reproduce the Vitro assays using culture of monocytes, co-culture of T cells and dendritic cells.
Based on data from contextualized assays, the investigators will select, test, and validate candidates' surrogate markers of trained immunity and heterologous immunity.The TSH-IMMO is a prospective cohort study.
Participants aged 1 to 12 years and living in Lambaréné, Gabon, will be recruited.
Eligibility Criteria
Inclusion Criteria:Healthy children aged 1 to 12 yearsResidence in the study area or surroundings for the period of the studyWritten informed consent from parents/legally acceptable representatives and an assent for children (age will depend on local country regulations)Exclusion Criteria:Complicated symptomatic malaria (defined according to standard World Health Organization criteria)Anaemia (Hb<7g/dL),Any (chronic) illness that requires immediate clinical careFamily history of sudden death or of congenital or clinical conditions known to prolong QTcB or QTcF interval or e.g.
family history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or severe cardiac diseaseAny treatment which can induce a lengthening of Q.T. intervalKnown history of hypersensitivity or allergic reactions to piperaquine or other aminoquinolines and LumefantrineReceipt of any blood transfusion or immunoglobulins within 3 monthsKnown history of hypersensitivity or allergic reactions to artesunateSevere malnutrition (weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalized reference values).Weight below 5 kgCurrent participation in malaria vaccine trialsCurrent active participation in any trial involving administration of investigational drug.Any severe drug-drug interactions, antimalarial, antihelminth and antibiotics
Source: ClinicalTrials.gov (NCT05722054). StuddyBuddy aggregates publicly available trial information.