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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaccine Breakthrough Infections
• Intervention / Treatment: Other: Blood and saliva sampling; Other: Survey

• Study Type: Observational
• Enrollment (Estimated): 410

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed by healthy subjects which have to receive a vaccine update in order to be deployed

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocytes' functional reprogramming	describing the functional reprogramming of monocytes following vaccination sessions among military personnel prior and after deployment	11 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Breakthrough Infections
• Other Study ID Numbers: 2023PPRC01; 2023-A01356-39 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No