NCT07275489

Brief Summary

Living for long periods in extreme environments-like Antarctic research stations or space missions-can have a significant impact on human health, especially on the immune system. Scientists have observed that people in such isolated conditions often experience more infections and a reactivation of viruses that usually stay dormant in the body, such as Herpes viruses. These changes affect both parts of the immune system: the rapid-response "innate" system and the slower, more specific "adaptive" system. These immune disruptions may be caused by multiple stressors: ongoing psychological stress, disturbed sleep and light cycles (circadian rhythm disruption), and the challenges of living in confined, isolated, and extreme environments. While space missions and Antarctic overwintering programs have provided some insight into these issues, scientists still lack a detailed understanding of how the immune system adapts-or fails to adapt-over time in such conditions. To help fill this gap, the CHOICE Kerguelen 2 study will follow a group of healthy young adults who will spend one year (from November 2025 to November 2026) in Port-aux-Français, a remote French research station on the Kerguelen Islands in the sub-Antarctic. These volunteers are participating in a civic service program and will be living in a highly isolated environment for the duration of their mission. The CHOICE Kerguelen study is conducted in collaboration with the French Polar Institute (IPEV). The goal of the study is to collect and store a broad range of biological samples-including blood, saliva, stool, urine, and hair-from these volunteers at four time points during the time of their confinement on the Kerguelent Islands: tevery three months during their stay. These samples will be than analyzed to characterize the immune profiles and intestinal microbiota of the subjects assess eventual viral reactivations and stress biological markers. These analyses will allow to better understand how the immune system reacts to prolonged isolation, and to identify immune profiles that may develop under prolonged stress and limited social contact. The long-term aim of this project is not only to improve our understanding of human immunity in extreme environments, but also to inform medical research for people living with chronic illness. By studying healthy individuals placed in physically and mentally challenging environments, scientists can better understand how stress and isolation may weaken immune defenses. The findings may one day help design new approaches to support immune health in vulnerable populations.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

November 27, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

November 27, 2025

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (24)

  • lymphocytes subsets during overwintering on the Kerguelen Islands

    lymphocytes subsets by flow cytometry

    At inclusion (3 months after the beginning of overwintering)

  • lymphocytes subsets during overwintering on the Kerguelen Islands

    lymphocytes subsets by flow cytometry

    At 3 months (6 months after the beginning of overwintering )

  • lymphocytes subsets during overwintering on the Kerguelen Islands

    lymphocytes subsets by flow cytometry

    At 6 months (9 months after the beginning of overwintering )

  • lymphocytes subsets during overwintering on the Kerguelen Islands

    lymphocytes subsets by flow cytometry

    At 9 months (12 months after the beginning of overwintering )

  • RNAsep during overwintering on the Kerguelen Islands

    RNAseq

    At inclusion (3 months after the beginning of overwintering )

  • RNAsep during overwintering on the Kerguelen Islands

    RNAseq

    At 3 months (6 months after the beginning of overwintering )

  • RNAsep during overwintering on the Kerguelen Islands

    RNAseq

    At 6 months (9 months after the beginning of overwintering )

  • RNAsep during overwintering on the Kerguelen Islands

    RNAseq

    At 9 months (12 months after the beginning of overwintering )

  • plasmatic cytokines during overwintering on the Kerguelen Islands

    plasmatic cytokines by Bioplex

    At inclusion (3 months after the beginning of overwintering )

  • plasmatic cytokines during overwintering on the Kerguelen Islands

    plasmatic cytokines by Bioplex

    At 3 months (6 months after the beginning of overwintering )

  • plasmatic cytokines during overwintering on the Kerguelen Islands

    plasmatic cytokines by Bioplex

    At 6 months (9 months after the beginning of overwintering )

  • plasmatic cytokines during overwintering on the Kerguelen Islands

    plasmatic cytokines by Bioplex

    At 9 months (12 months after the beginning of overwintering )

  • fecal microbiota

    fecal microbiota by bacterial sequencing

    At inclusion (3 months after the beginning of overwintering )

  • fecal microbiota

    fecal microbiota by bacterial sequencing

    At 3 months (6 months after the beginning of overwintering )

  • fecal microbiota

    fecal microbiota by bacterial sequencing

    At 6 months (9 months after the beginning of overwintering )

  • fecal microbiota

    fecal microbiota by bacterial sequencing

    At 9 months (12 months after the beginning of overwintering )

  • hormonal stress markers during overwintering on the Kerguelen Islands

    hormonal stress markers assessment in blood/urinary/hair by Elisa and nephelemetry

    At inclusion (3 months after the beginning of overwintering )

  • hormonal stress markers during overwintering on the Kerguelen Islands

    hormonal stress markers assessment in blood/urinary/hair by Elisa and nephelemetry

    At 3 months (6 months after the beginning of overwintering )

  • hormonal stress markers during overwintering on the Kerguelen Islands

    hormonal stress markers assessment in blood/urinary/hair by Elisa and nephelemetry

    At 6 months (9 months after the beginning of overwintering )

  • hormonal stress markers during overwintering on the Kerguelen Islands

    hormonal stress markers assessment in blood/urinary/hair by Elisa and nephelemetry

    At 9 months (12 months after the beginning of overwintering )

  • stress profile during overwintering on the Kerguelen Islands

    psychological stress by CST test form

    At inclusion (3 months after the beginning of overwintering )

  • stress profile during overwintering on the Kerguelen Islands

    psychological stress by CST test form

    At 3 months (6 months after the beginning of overwintering )

  • stress profile during overwintering on the Kerguelen Islands

    psychological stress by CST test form

    At 6 months (9 months after the beginning of overwintering )

  • stress profile during overwintering on the Kerguelen Islands

    psychological stress by CST test form

    At 9 months (12 months after the beginning of overwintering )

Secondary Outcomes (16)

  • EBV viral reactivations during overwintering on the Kerguelen Islands

    At inclusion (3 months after the beginning of overwintering )

  • EBV viral reactivations during overwintering on the Kerguelen Islands

    At 3 months (6 months after the beginning of overwintering )

  • EBV viral reactivations during overwintering on the Kerguelen Islands

    At 6 months (9 months after the beginning of overwintering )

  • EBV viral reactivations during overwintering on the Kerguelen Islands

    At 9 months (12 months after the beginning of overwintering )

  • CMV viral reactivations during overwintering on the Kerguelen Islands

    At inclusion (3 months after the beginning of overwintering )

  • +11 more secondary outcomes

Study Arms (1)

HD (healthy donors)

Other: blood ponctionOther: urines collectionOther: hair collectionOther: saliva collectionOther: stools collection

Interventions

blood ponction

HD (healthy donors)

urines collection

HD (healthy donors)

hair collection

HD (healthy donors)

saliva collection

HD (healthy donors)

stools collection

HD (healthy donors)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participant included in the CELREMED research project of the University Hospital of Angers on helathy volunteers in the context of CHOICE Kerguelen 1 protocol

You may qualify if:

  • healthy people aged \> 18 years
  • Participant affiliated with or benefiting from a social security system
  • Participant has signed informed consent
  • Participant staying as an overwintering member at Kerguelen from November 2025 to November 2026
  • Participant included in the CELREMED research project of the University Hospital of Angers on helathy volunteers in the context of CHOICE Kerguelen 1 protocol

You may not qualify if:

  • age \< 18 years
  • Pregnant, breastfeeding, or postpartum woman
  • immunocompromised people (primary immunodeficiency, HIV infection or immunosupressive treatment)
  • Person refusing to participate in the study
  • Person with a history of autoimmune disease - -Person deprived of liberty by judicial or administrative decision
  • Person undergoing involuntary psychiatric treatment
  • Person subject to a legal protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital SAMUKER, Port-aux-français/ Archipel KERGUELEN /Terres Australes et Antarctiques Françaises

Port-aux-Français, Terres Australes Et Antarctiques Françaises, French Southern and Antarctic Lands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, PBMCs, plasma, serum, urine, saliva, stools, hair

Study Officials

  • Charline MIOT, MD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 10, 2025

Study Start

December 20, 2025

Primary Completion

January 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
Access Criteria
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).

Locations