Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

NCT03659773 | Completed

• 2 other identifiers: 69HCL17_07692017-A03230-53
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vaccination; Hematopoietic Stem Cells

Keywords

Hematopoietic stem cell transplantation; allogeneic hematopoietic stem cell transplantation; autologous hematopoietic stem cell transplantation; vaccination; vaccines; immune function

Outcome Measures

Primary Outcomes (1)

• proportion of responders defined by the increase in specific antibody titers at 3 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV).

  ELISA methods will be used to measure serum level concentrations of specific immunoglobulin G (IgG) antibodies to tetanus toxoid, diphtheria toxoid, Hib, pneumococcal capsular polysaccharides and HBV. For pneumococcus, a 4-fold increase in the IgG titer will be considered significant for immunization. For Hib, the values between 0.15-1 μg/mL will be significant for immunization (linearity limit of 9 μg/mL). An IgG titer equal or higher than 0.1 IU/mL for diphtheria and tetanus and higher than 10 mIU/mL for HBV (anti-HBs antibody titer will be considered protective) . An anti-HBs titer higher than 100 IU/mL will be considered to confer long-lasting protection.

  at 3 months after block vaccination

Secondary Outcomes (7)

• proportion of responders defined by the increase in specific antibody titers at 12 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV).

  at 12 months after block vaccination

• proportion of responders defined by the increase in specific antibody titers at 24 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV).

  at 24 months after block vaccination

• Correlation between quantification of relevant immune cells of HSCT recipients and vaccine response

  at 3, 12 and 24 months after full block vaccination

• Correlation between proliferative T-cell response to mitogens and antigens and vaccine response

  before and at 3 months after full block vaccination

• Correlation between innate immune response after ex vivo whole blood stimulation and vaccine response

  before and at 3 months after full block vaccination

Study Arms (1)

hematopoietic stem cell transplant (HSCT)

EXPERIMENTAL

immune biomarkers to evaluate vaccine response in HSCT recipients

Biological: immune biomarkers to evaluate vaccine response in HSCT recipients

Interventions

immune biomarkers to evaluate vaccine response in HSCT recipients 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

hematopoietic stem cell transplant (HSCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• BioMérieux: collaborator

Study Sites (2)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Related Publications (1)

• Conrad A, Boccard M, Valour F, Alcazer V, Tovar Sanchez AT, Chidiac C, Laurent F, Vanhems P, Salles G, Brengel-Pesce K, Meunier B, Trouillet-Assant S, Ader F; Lyon HEMINF Study Group. VaccHemInf project: protocol for a prospective cohort study of efficacy, safety and characterisation of immune functional response to vaccinations in haematopoietic stem cell transplant recipients. BMJ Open. 2019 Feb 15;9(2):e026093. doi: 10.1136/bmjopen-2018-026093.

  PMID: 30772864 BACKGROUND

Study Officials

• Florence ADER, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: September 6, 2018
• Study Start: April 27, 2018
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2023
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)