VaxInnate: Evaluation of the Consequences of Poly Vaccination on Innate Immunity : Applications to a Military Population

Sponsor

Direction Centrale du Service de Santé des Armées (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06110741

Collaborator

(none)

410

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this study, the poly vaccination of military personnel prior to deployment will be analyzed in terms of central, peripheral and long-lasting changes in innate immunity.

Analysis of monocyte immune training induced by vaccination will provide a better understanding of the indirect effects of vaccination and their persistence over time.

Condition or Disease	Intervention/Treatment	Phase
Vaccine Breakthrough Infections	Other: Blood and saliva sampling Other: Survey

Study Design

Study Type:

Observational

Anticipated Enrollment :

410 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

VaxInnate : Evaluation of the Consequences of Poly Vaccination on Innate Immunity : Applications to a Military Population

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Sampling and survey group This group will complete questionnaires and participate in sample collection.	Other: Blood and saliva sampling Collecting blood and saliva sample Other: Survey Collecting data on infectious diseases during the study period
Survey group This group will only complete questionnaires	Other: Survey Collecting data on infectious diseases during the study period

Arm

Intervention/Treatment

Sampling and survey group

This group will complete questionnaires and participate in sample collection.

Other: Blood and saliva sampling

Collecting blood and saliva sample

Other: Survey

Collecting data on infectious diseases during the study period

Survey group

This group will only complete questionnaires

Other: Survey

Collecting data on infectious diseases during the study period

Outcome Measures

Primary Outcome Measures

Monocytes' functional reprogramming [11 months]
describing the functional reprogramming of monocytes following vaccination sessions among military personnel prior and after deployment

Secondary Outcome Measures

Identify immune signatures [11 months]
Identifying immune signatures by comparing the functional reprogramming of monocytes by different vaccines and co vaccinations schemes
Time persistence [11 months]
Assess the persistence over time of the effects by follow-up after return from mission

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

french military personnel
18yo
overseas deployment scheduled between 30 and 60 days after vaccination session
adult
able to give consent

Exclusion Criteria:

unrectified military personnel
having received a live vaccine within 6 months prior to inclusion
having received an attenuated vaccine within 3 months prior to inclusion
pregnancy or breastfeeding
vaccine contraindication
major incapacity

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Direction Centrale du Service de Santé des Armées

ClinicalTrials.gov Identifier:

NCT06110741

Other Study ID Numbers:

2023PPRC01
2023-A01356-39

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 1, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breakthrough Infections

Study Results

No Results Posted as of Nov 1, 2023