Vaccine Breakthrough InfectionsVaxInnateNCT06110741
Evaluation of the Consequences of Poly Vaccination on Innate Immunity : Applications to a Military Population
An observational study of Vaccine Breakthrough Infections, run by Direction Centrale du Service de Santé des Armées.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Breakthrough Infections
- What is being tested?
- Blood and saliva sampling and Survey
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population is composed by healthy subjects which have to receive a vaccine update in order to be deployed
Who may be able to join
- french military personnel
- >18yo
- overseas deployment scheduled between 30 and 60 days after vaccination session
- adult
- able to give consent
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Vaccine Breakthrough Infections
- Being tested
- Blood and saliva sampling, Survey
- Medical subject headings
- Breakthrough Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and saliva samplingOther
Collecting blood and saliva sample
SurveyOther
Collecting data on infectious diseases during the study period
| Study group | Role | What they receive |
|---|---|---|
| Sampling and survey group | This group will complete questionnaires and participate in sample collection. Receives: Other: Blood and saliva sampling; Other: Survey | |
| Survey group | This group will only complete questionnaires Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocytes' functional reprogramming
describing the functional reprogramming of monocytes following vaccination sessions among military personnel prior and after deployment
Measured: 11 months
Secondary outcomes (2)
Identify immune signatures
Identifying immune signatures by comparing the functional reprogramming of monocytes by different vaccines and co vaccinations schemes
Measured: 11 months
Time persistence
Assess the persistence over time of the effects by follow-up after return from mission
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Breakthrough InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110741
- Sponsor's protocol ID
- 2023PPRC01
- Other IDs
- 2023-A01356-39
- Acronym
- VaxInnate
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VaxInnate : Evaluation of the Consequences of Poly Vaccination on Innate Immunity : Applications to a Military Population
- ClinicalTrials.gov ID
- NCT06110741
- Acronym / sponsor ID
- VaxInnate / 2023PPRC01
- Conditions
- Vaccine Breakthrough Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sampling and survey group | – | Other: Blood and saliva sampling, Other: SurveyThis group will complete questionnaires and participate in sample collection. |
| Survey group | – | Other: SurveyThis group will only complete questionnaires |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is composed by healthy subjects which have to receive a vaccine update in order to be deployed
Key inclusion criteria (5 listed)
- french military personnel
- >18yo
- overseas deployment scheduled between 30 and 60 days after vaccination session
- adult
- able to give consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and saliva samplingCollecting blood and saliva sample | Other | Sampling and survey group |
| SurveyCollecting data on infectious diseases during the study period | Other | Sampling and survey group, Survey group |
Primary outcome
Monocytes' functional reprogramming
Time frame: 11 months
describing the functional reprogramming of monocytes following vaccination sessions among military personnel prior and after deployment
2 secondary outcomes
Identify immune signatures
Time frame: 11 months
Time persistence
Time frame: 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Breakthrough Infections, run by Direction Centrale du Service de Santé des Armées.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocytes' functional reprogramming (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.