Genomic Approaches to Dissect Human Host-pathogen Interactions in the Amazonian Rainforest

NCT ID: NCT05981378

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-02
• Study Completion Date: 2025-01-30

Brief Summary

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.

Detailed Description

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.

Conditions

Host-Pathogen Interactions

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Native Amazonian group

Amazonian people that belongs to a indigenous community located in the Peruvian Amazon

No interventions assigned to this group

Urban Amazonian mestizos group

Amazonian mestizo people that lives on a urban district in the Peruvian Amazon

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• People over 18 years of age who agree to participate in the study and sign the informed consent
• People whose parents and grandparents were born in the Peruvian Amazon.
• For volunteers from native communities, whose parents and grandparents belong to the same native community.

Exclusion Criteria

• People who do not wish to have 40 mL of blood taken
• People who are passing through a febrile illness (fever during the last 5 days to the date of enrollment).
• Pregnant women
• People over 65 years old
• Breastfeeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur

INDUSTRY

Sponsor Role: collaborator

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Meddly Santoalla, PhD

Role: CONTACT

meddly.santolalla.r@upch.pe

+51 914068043

Study Documents

Document Type: Study Protocol

Google drive link to visualize the study protocol in Spanish and English

View Document

Related Links

https://investigacion.cayetano.edu.pe/duari/ciei/

Web page of the ethical review board of Universidad Peruana Cayetano Heredia

Other Identifiers

210828

Identifier Type: -

Identifier Source: org_study_id