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

NCT06110741 | Not Yet Recruiting

• 2 other identifiers: 2023PPRC012023-A01356-39
• Study Type: observational
• Target: 410
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vaccine Breakthrough Infections

Outcome Measures

Primary Outcomes (1)

• Monocytes' functional reprogramming

  describing the functional reprogramming of monocytes following vaccination sessions among military personnel prior and after deployment

  11 months

Secondary Outcomes (2)

• Identify immune signatures

  11 months

• Time persistence

  11 months

Study Arms (2)

Sampling and survey group

This group will complete questionnaires and participate in sample collection.

Other: Blood and saliva sampling; Other: Survey

Survey group

This group will only complete questionnaires

Other: Survey

Interventions

Blood and saliva sampling OTHER

Collecting blood and saliva sample

Sampling and survey group

Survey OTHER

Collecting data on infectious diseases during the study period

Sampling and survey group; Survey group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• unrectified military personnel
• pregnancy or breastfeeding
• vaccine contraindication
• major incapacity

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample and saliva sample

MeSH Terms

Conditions

Breakthrough Infections

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share