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VaccinationVaccHemInfNCT03659773

Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

A study testing immune biomarkers to evaluate vaccine response in HSCT recipients in people with Vaccination and Hematopoietic Stem Cells, run by Hospices Civils de Lyon at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Vaccination, Hematopoietic Stem Cells
What is being tested?
immune biomarkers to evaluate vaccine response in HSCT recipients
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
2 sitesFrance
Study dates
27 Apr 2018to 21 Jan 2023
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Additional inclusion criteria for healthy volunteers enrolled (10 volunteers)in the ancillary study of influenza vaccine response:
  • health-care workers recruited from the hospital staff

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital de la Croix Rousse

    Lyon, 69004

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

Other trials in France

About this study

Official title: A Prospective Cohort Study of Efficacy, Safety and Characterization of Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

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.

Being tested
immune biomarkers to evaluate vaccine response in HSCT recipients
Keywords
Hematopoietic stem cell transplantation, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, vaccination, vaccines, immune function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • immune biomarkers to evaluate vaccine response in HSCT recipientsBiological

    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

Study groups in NCT03659773
Study groupRoleWhat they receive
hematopoietic stem cell transplant (HSCT)Experimentalimmune biomarkers to evaluate vaccine response in HSCT recipients
Receives: Biological: immune biomarkers to evaluate vaccine response in HSCT recipients

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 3 months after block vaccination

Secondary outcomes (7)

  1. 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).

    ELISA methods will be used to measure serum level concentrations of specific 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 the 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

    Measured: at 12 months after block vaccination

  2. 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).

    ELISA methods will be used to measure serum level concentrations of specific 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 the 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

    Measured: at 24 months after block vaccination

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

    the association between blood T- B- and NK cell counts and subtypes of T and B cells (cells /mm3 of whole blood) and vaccine response will be analyzed

    Measured: at 3, 12 and 24 months after full block vaccination

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

    lymphocyte proliferation in response to ex vivo T cell stimulation (% of proliferating cells among CD3+ T-cells) will be evaluated The values measured will be defined as normal or abnormal, depending on whether they are within reference intervals (RI) derived from an independent set of healthy volunteers (REALISM protocol).

    Measured: before and at 3 months after full block vaccination

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

    The production of tumor necrosis factor (TNF) alpha released by blood cells in response to ex vivo stimulation by lipopolysaccharide (in pg/mL) will be measured The values measured will be defined as normal or abnormal, depending on whether they are within reference intervals (RI) derived from an independent set of healthy volunteers (REALISM protocol).

    Measured: before and at 3 months after full block vaccination

  6. proportion of HSCT recipients with adverse event after each vaccination including local and general reactions

    local and general reactions will be monitored for 30 min after each vaccination. Recipients will be given a diary card to record occurrence and severity of specific local reactions at the injection site and specific general reactions for 21 days after each vaccine injection.

    Measured: 21 days after each vaccination

  7. ancillary study of cellular and humoral response to one dose of tetravalent inactivated influenza vaccine (IIV)

    Hemagglutination-inhibition assay (HAI) will be used to measure serum level concentrations of specific antibodies to the four influenza strains included in the vaccine.

    Immunization will be defined by seroprotective antibody titers ≥ 1:40 and/or seroconversion (4-fold rise in antibody titers).

    T-cell responses elicited by IIV will be measured ex vivo by interferon-Gamma ELISpot assay and expressed as number of spot-forming-cells.

    T-cell responses will be correlated to influenza antibody production, as measured by hemagglutination-inhibition assay (HAI).

    Influenza vaccine response in allo-HSCT recipients will be compared to that observed in Healthy Volunteers.

    Measured: 4 weeks after influenza vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2018
  2. Study start27 Apr 2018
  3. Primary completion21 Jan 2021
  4. Study completion21 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03659773
Sponsor's protocol ID
69HCL17_0769
Other IDs
2017-A03230-53
Acronym
VaccHemInf
Status last verified
Aug 2025
First submitted
25 Jul 2018
Last updated
4 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30772864

Questions about this trial

What is this clinical trial studying?

A study testing immune biomarkers to evaluate vaccine response in HSCT recipients in people with Vaccination and Hematopoietic Stem Cells, run by Hospices Civils de Lyon at 2 sites in France.

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 6 inclusion and 4 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: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). (time frame: at 3 months after block vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03659773, which also lists 1 linked publication.

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 4 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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