Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2023-01-21

Brief Summary

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Hematopoietic stem cell transplantation (HSCT) is a cellular therapy aiming at curing some hematological diseases. Upon transplantation, recipients experience a phase of profound immune suppression with loss of protective immunity against most infectious agents. Revaccination of HSCT recipients against vaccine-preventable infections is an important post-transplant intervention for reducing morbi-mortality. The VaccHemInf project aims at assessing the efficacy of recommended vaccines in adult recipients of HSCT, through the antibody titers reference method and a panel of immune functional assays.

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Detailed Description

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Conditions

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Vaccination Hematopoietic Stem Cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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hematopoietic stem cell transplant (HSCT)

immune biomarkers to evaluate vaccine response in HSCT recipients

Group Type EXPERIMENTAL

immune biomarkers to evaluate vaccine response in HSCT recipients

Intervention Type BIOLOGICAL

a 38mL-blood sample will be collected before and at 3, 12 and 24 months after complete block vaccination and at 4 weeks after influenza vaccination for the ancillary study

Interventions

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immune biomarkers to evaluate vaccine response in HSCT recipients

a 38mL-blood sample will be collected before and at 3, 12 and 24 months after complete block vaccination and at 4 weeks after influenza vaccination for the ancillary study

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* allogeneic and autologous HSCT recipients
* ≥ 18 year-old
* patients having been informed of the conditions of the study (24-month follow-up) and having signed the informed consent form
* Person with social security insurance

* health-care workers recruited from the hospital staff

Exclusion Criteria

* Patient with innate or acquired immune deficiency (severe combined immunodeficiency, Hepatitis C virus (HCV), HBV, HIV infections at any stage)
* Pregnant or breastfeeding women
* History of previous severe allergic reaction to vaccine components
* Patient with no social security coverage, with restricted liberty or under legal protection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes