Tropical Infectious DiseaseTSH-IMMONCT05722054
Trained and Heterologous Induced-immune Responses to Tropical Infectious Diseases
An observational study of Tropical Infectious Disease, run by Centre de Recherche Médicale de Lambaréné.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tropical Infectious Disease
- What is being tested?
- Diagnostic tests and Equilibrate diet
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Trained and Heterologous Induced-immune Responses to Tropical Infectious Diseases: Selection and Validation of Immune Assays in Children Aged 1-12 Years Living in Lambaréné, Gabon
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.
Read the detailed description
Overview of the study The investigators will conduct a prospective cohort study. Participants aged 1 to 12 years will be recruited and undergo baseline clinical and biological assessments and receive a curative dose of either artemether-Lumefantrine or dihydroartemisinin-piperaquine to clear any existing P.falciparum parasitemia. Clearance of parasites will be confirmed 3 weeks later by PCR, and only participants with negative PCR will be definitively enrolled for the longitudinal follow up. Both active and passive case detection will ensure that a high proportion of infections in the cohort is captured. In addition, participants with any other active tropical infections except the viral infections will be treated within the three weeks according to national treatment guidelines.
For the active follow up, participants will be actively seen every month for supervised clinical evaluations and to collect blood samples for detecting tropical infections according to the gold-standard test, PCR and serodiagnosis. Participants will be followed passively in parallel to monthly visits; diagnosis of tropical infectious diseases will be performed upon clinical evaluation. Participants will be followed for 12 months.
Screening The screening visit aims to determine subject eligibility for study participation. Screening procedures follow Informed consent procedures, clinical assessments, diagnosis of tropical infections, and hemoglobin level. Baseline immune responses will also be performed.
- falciparum parasite clearance and treatment of other tropical infections. All children, irrespective of malaria parasite status, will receive a curative antimalarial dose to clear any existing parasitaemia. Children will be treated according to local guidelines when found with an active infection of M. perstans, Loa, loa, Dengue virus, Chikungunya virus, SARS-CoV2, resistant bacteria, S. haematobium, N. americanus, Ascaris lumbricoides, Trichuris trichiura, S. stercoralis, protozoa spp.
Follow up of enrolled participants The study will combine active and passive case detection surveys with meeting study objectives and capturing full episodes of tropical infections from enrolled study participants. In addition, studies on trained and heterologous immunity will take place.
For P. falciparum
The following procedures will be followed:
- Questioning for symptoms of malaria, prevention measures, fever and medication since the previous visit
- Temperature measurement
- Perform careful clinical examination and syndrome summary
- Venous blood sample collection
- Blood smear
- Rapid diagnostic test (RDT)
- Parasite DNA extraction
Children with fever or history of fever will be referred to the local health centre:
- Rapid diagnostic test (RDT) in case of history of fever in 24 H/ fever (Axillary temperature ≥37.5°C/Tympanic ≥38°C or Forehead temperature ≥37.5°C using non- contact infrared thermometer) (50 μL)
- Confirmed malaria cases will follow these procedures:
- Treatment as per government guidelines.
- Others causes of fever will be managed according to the national guidelines.
For other pathogens The detection takes place every month at the clinic of CERMEL.
- Questioned for symptoms of disease induced by the targeted pathogens, prevention measures, fever and medication since the previous visit
- Perform careful clinical examination and syndrome summary
- EDTA for RDT, blood smear, complete blood count, microfilaria (microscopy and Leucoconcentration), DNA and RNA extraction
- Urine sample for S. haematobium, bacteria
- Nasal and throat swabs for SARS-CoV2
- Throat swabs for bacteria
- Stool examination for helminths and protozoa
For trained and heterologous immunity Human DNA extraction; cell cultures and analyses; seroprevalence studies
- Conditions
- Tropical Infectious Disease
- Being tested
- Diagnostic tests, Equilibrate diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testsOther
Blood smears; rapid diagnostic tests; complete blood counts with differential; "leucoconcentration"; urine examination; nasal/throat swabs, stool examination.
Equilibrate dietOther
Nutritionally-balanced Alimentation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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. Receives: 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. Receives: Other: Diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tropical Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722054
- Sponsor's protocol ID
- CEI-007/2022
- Acronym
- TSH-IMMO
- Status last verified
- Feb 2023
- First submitted
- 3 Dec 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trained and Heterologous Induced-immune Responses to Tropical Infectious Diseases: Selection and Validation of Immune Assays in Children Aged 1-12 Years Living in Lambaréné, Gabon
- ClinicalTrials.gov ID
- NCT05722054
- Acronym / sponsor ID
- TSH-IMMO / CEI-007/2022
- Conditions
- Tropical Infectious Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overview of the study The investigators will conduct a prospective cohort study. Participants aged 1 to 12 years will be recruited and undergo baseline clinical and biological assessments and receive a curative dose of either artemether-Lumefantrine or dihydroartemisinin-piperaquine to clear any existing P.falciparum parasitemia. Clearance of parasites will be confirmed 3 weeks later by PCR, and only participants with negative PCR will be definitively enrolled for the longitudinal follow up. Both active and passive case detection will ensure that a high proportion of infections in the cohort is captured. In addition, participants with any other active tropical infections except the viral infections will be treated within the three weeks according to national treatment guidelines.
For the active follow up, participants will be actively seen every month for supervised clinical evaluations and to collect blood samples for detecting tropical infections according to the gold-standard test, PCR and serodiagnosis. Participants will be followed passively in parallel to monthly visits; diagnosis of tropical infectious diseases will be performed upon clinical evaluation. Participants will be followed for 12 months.
Screening The screening visit aims to determine subject eligibility for study participation. Screening procedures follow Informed consent procedures, clinical assessments, diagnosis of tropical infections, and hemoglobin level. Baseline immune responses will also be performed.
- falciparum parasite clearance and treatment of other tropical infections. All children, irrespective of malaria parasite status, will receive a curative antimalarial dose to clear any existing parasitaemia. Children will be treated according to local guidelines when found with an active infection of M. perstans, Loa, loa, Dengue virus, Chikungunya virus, SARS-CoV2, resistant bacteria, S. haematobium, N. americanus, Ascaris lumbricoides, Trichuris trichiura, S. stercoralis, protozoa spp.
Follow up of enrolled participants The study will combine active and passive case detection surveys with meeting study objectives and capturing full episodes of tropical infections from enrolled study participants. In addition, studies on trained and heterologous immunity will take place.
For P. falciparum
The following procedures will be followed:
- Questioning for symptoms of malaria, prevention measures, fever and medication since the previous visit
- Temperature measurement
- Perform careful clinical examination and syndrome summary
- Venous blood sample collection
- Blood smear
- Rapid diagnostic test (RDT)
- Parasite DNA extraction
Children with fever or history of fever will be referred to the local health centre:
- Rapid diagnostic test (RDT) in case of history of fever in 24 H/ fever (Axillary temperature ≥37.5°C/Tympanic ≥38°C or Forehead temperature ≥37.5°C using non- contact infrared thermometer) (50 μL)
- Confirmed malaria cases will follow these procedures:
- Treatment as per government guidelines.
- Others causes of fever will be managed according to the national guidelines.
For other pathogens The detection takes place every month at the clinic of CERMEL.
- Questioned for symptoms of disease induced by the targeted pathogens, prevention measures, fever and medication since the previous visit
- Perform careful clinical examination and syndrome summary
- EDTA for RDT, blood smear, complete blood count, microfilaria (microscopy and Leucoconcentration), DNA and RNA extraction
- Urine sample for S. haematobium, bacteria
- Nasal and throat swabs for SARS-CoV2
- Throat swabs for bacteria
- Stool examination for helminths and protozoa
For trained and heterologous immunity Human DNA extraction; cell cultures and analyses; seroprevalence studies
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Incidence of tropical infectious diseases | – | Other: Diagnostic testsAll 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. |
| Healthy and equilibrate diet | – | Other: Equilibrate dietOne-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 |
| In vitro | – | Other: Diagnostic tests30 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 |
| Adaptive in vitro | – | Other: Diagnostic tests100 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. |
| Ex vivo | – | Other: Diagnostic testsAll 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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testsBlood smears; rapid diagnostic tests; complete blood counts with differential; "leucoconcentration"; urine examination; nasal/throat swabs, stool examination. | Other | Adaptive in vitro, Ex vivo, In vitro, Incidence of tropical infectious diseases |
| Equilibrate dietNutritionally-balanced Alimentation | Other | Healthy and equilibrate diet |
Primary outcome
Incidence, morbidity, and transmission of tropical infectious diseases
Time frame: At 12 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Tropical Infectious Disease, run by Centre de Recherche Médicale de Lambaréné.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selidji T Agnandji, MD/PhD (077 35 31 14 ext. +241, agnandjis@cermel.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, morbidity, and transmission of tropical infectious diseases (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.