Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722054
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-10
First Post:
2022-12-03
Brief Title:
Trained and Heterologous Induced-immune Responses to Tropical Infectious Diseases
Sponsor:
Centre de Recherche Médicale de Lambaréné
Organization:
Centre de Recherche Médicale de Lambaréné
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TSH-IMMO
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
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 Pfalciparum 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
P 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 375CTympanic 38C or Forehead temperature 375C using non- contact infrared thermometer 50 μL
Confirmed malaria cases will follow these procedures
o 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
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
P 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 375CTympanic 38C or Forehead temperature 375C using non- contact infrared thermometer 50 μL
Confirmed malaria cases will follow these procedures
o 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None