Trained and Heterologous Induced-immune Responses to Tropical Infectious Diseases

NCT05722054 | Unknown DMC

• 1 other identifier: CEI-007/2022
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tropical Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Incidence, morbidity, and transmission of tropical infectious diseases

  To assess the incidence/ transmission of P. falciparum, M. perstans, Loa, loa, Dengue virus, Chikungunya virus, SARS-CoV2, resistant bacteria, S. haematobium, N. americanus, Ascaris lumbricoides, Trichuris trichiura, S. stercoralis, protozoa spp

  At 12 months

Study Arms (5)

Incidence of tropical infectious diseases

All study participants will be followed up for 12 months through active and passive detection visits. Active detection takes place every month for all pathogens except for P. falciparum which is detected every two weeks.

Other: Diagnostic tests

Healthy and equilibrate diet

One-fourth of the study participants will be randomly assigned to receive an equilibrate diet for 21 days comprising breakfast, lunch and educational recommendations for an equilibrate diet

Other: Equilibrate diet

In vitro

30 to 50 participants selected from the study population. The in vitro study procedures are performed at the screening visit and every two months+/- 1, and when an active case of tropical infection occurs

Other: Diagnostic tests

Adaptive in vitro

100 to 150 selected participants. The adaptive in vitro study procedures are performed at the screening visit and every two months+/- 1 and when an active case of tropical infection occurs.

Other: Diagnostic tests

Ex vivo

All study participants. The ex vivo are performed at the screening visit and every two months+/- 1 and when an active case of tropical infection occurs.

Other: Diagnostic tests

Interventions

Diagnostic tests OTHER

Blood smears; rapid diagnostic tests; complete blood counts with differential; "leucoconcentration"; urine examination; nasal/throat swabs, stool examination.

Adaptive in vitro; Ex vivo; In vitro; Incidence of tropical infectious diseases

Equilibrate diet OTHER

Nutritionally-balanced Alimentation

Healthy and equilibrate diet

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The TSH-IMMO study will be conducted at the Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon. CERMEL has established a demographic and health surveillance system that covers Lambaréné and a radius of about 70 Km away in both North and South directions. About 8,000 households are in the surveillance system. Our surveillance system has estimated that 30,000 inhabitants live in the area and about 27% are aged 1-12 years old. There are 1 to 24 inhabitants in the households, with a median of 3-4 inhabitants per household.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de Recherche Médicale de Lambaréné: lead

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Whole blood

Central Study Contacts

Selidji T Agnandji, MD/PhD

CONTACT

077 35 31 14; agnandjis@cermel.org

Ayodele Alabi, MD

CONTACT

076261477; ayodele.alabi@cermel.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: February 10, 2023
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02