Trained and Heterologous Induced-immune Responses to Tropical Infectious Diseases (NCT05722054) | Clinical Trial Compass
UnknownNot Applicable
Trained and Heterologous Induced-immune Responses to Tropical Infectious Diseases
400 participantsStarted 2023-03
Plain-language 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.
Who can participate
Age range
1 Year – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy children aged 1 to 12 years
* Residence in the study area or surroundings for the period of the study
* Written 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 care
* Family 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 disease
* Any treatment which can induce a lengthening of Q.T. interval
* Known history of hypersensitivity or allergic reactions to piperaquine or other aminoquinolines and Lumefantrine
* Receipt of any blood transfusion or immunoglobulins within 3 months
* Known history of hypersensitivity or allergic reactions to artesunate
* Severe 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 kg
* Current participation in malaria vaccine trials
* Current active participation in any trial involving administration of investigational drug.
* Any severe drug-drug interactions, antimalarial, antihelminth and antibiotics
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence, morbidity, and transmission of tropical infectious diseases