An observational study in Host-Pathogen Interactions, sponsored by Universidad Peruana Cayetano Heredia. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Universidad Peruana Cayetano Heredia · Observational
This observational study, aims to characterize with a multi-omic approach, the impact of host genetics and the pathogenic environment on immune response variation in Native Amazonians in comparison with Mestizo Amazonian, a severely underrepresented population in genomic studies.
Various samples will be taken from the participants, including blood, urine, saliva, etc. From the blood sample, peripheral blood mononuclear cells will be obtained and will give us information about the differences between immune response variation of Amazonian population. From the other samples we will be able to obtain additional information on the risk factors related to the difference in the immune response of the participants.
The Amazon rainforest is characterized by adverse climatic conditions and a great diversity of pathogenic microorganisms that, consequently, would generate a selective pressure on the human immune response with a high impact on mortality. Some of the best characterized examples of human genetic adaptation have been related to infections; for example, the alleles causing sickle cell anemia, thalassemia and malaria. In addition, the introduction of infectious diseases from the "old world" during Spanish colonization in the 15th century and the urbanization of the last few centuries in the Amazon has also generated rapid adaptation that could drive variation in immune response. However, the evolutionary mechanisms that contributed to the adaptation of human defense against the aforementioned phenomena and events in this region are poorly understood. For this reason, studying these human genetic mechanisms in native populations would allow us to identify new genes that would be associated with resistance to infections, and also to explore the signs of rapid adaptation to the environment to which Amazonian populations have been exposed throughout their history.
We propose to study the variation of the immune system in Amazonian populations, studying together the degree of diversity with different approaches: genomic, epi-genomic and transcriptomic of the host and viral exposome, taking into consideration sociodemographic characteristics and comorbidities, which may shape the immune response. This study will provide new insights into variants in the human genome that affect the immune response, thereby increasing our understanding of the etiology and susceptibility to immune-related diseases, mainly tropical infectious diseases. Because human genetic studies are underrepresented in Native American populations, the knowledge gained would reduce the existing inequality in health knowledge between Native and non-Native populations.
Universidad Peruana Cayetano Heredia is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
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Amazonian Peruvian Native American and Amazonian mestizo population between 2023-2024
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Amazonian people that belongs to a indigenous community located in the Peruvian Amazon
Amazonian mestizo people that lives on a urban district in the Peruvian Amazon
Genes showing different transcriptional profiles and methylation pattern according environment, genetic ancestry and past viral exposure
We will measure genome-wide expression profiles in peripheral blood mononuclear cells after stimulation for 6 hours with: (i) dengue virus, a major public health burden in the region, (ii) gardiquimod, an imidazoquinoxaline compound that activates toll like receptor 7/toll like receptor 8, able to sense viruses and intracellular pathogens; and (iii) lipopolysaccharide, a toll like receptor 4 agonist, to obtain a general view of responses to viruses and bacteria. Gene expression profiles will be measured using RNA-seq.
Time frame: Baseline
Genetic and epigenetic diversity of amazonian population
Using saliva from participants as source of DNA, we will perform whole-genome sequencing (WGS) at 8-10xcoverage.
Time frame: Baseline
Impact of microbial exposures on immune response
The viral exposome will be characterized in the 300 donors using a new tool call "VirScan", which identifies antibodies against \>600 pathogens and allergens, including viruses (\>1,200 viral strains) that are highly prevalent in the Amazonian, such as dengue, hepatitis B/C/D, or Mayaro virus.
Time frame: Baseline
Genetic variants associated wit transcriptional response to immune activation and DNA methylation variation
We will assess the host genetic factors controlling transcriptional responses and methylated DNA levels by mapping expression and methylation quantitative trait loci (eQTL and methylated eQTLs, respectively).
Time frame: Baseline
Demographic and admixture history of amazonian population
Using saliva from participants as source of DNA, we will perform whole-genome sequencing (WGS) at 8-10xcoverage.
Time frame: Baseline
Natural selection role in shaping immune response variation in Amazonians
We will employ an enrichment approach to test whether eQTLs, associated to specific cell-types or conditions, have been preferentially targeted by selection.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Universidad Peruana Cayetano Heredia