Clinical trial NCT03659773: Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients
Official title: A Prospective Cohort Study of Efficacy, Safety and Characterization of Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Hematopoietic Stem Cells
Keywords: Hematopoietic stem cell transplantation
allogeneic hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation
vaccination
vaccines
immune function
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2018-09-06
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

  • 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

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.

Primary outcomes:
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).
timeFrame: at 3 months after block vaccination
Secondary outcomes:
measure: 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).
timeFrame: at 12 months after block vaccination
measure: 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).
timeFrame: at 24 months after block vaccination
measure: Correlation between quantification of relevant immune cells of HSCT recipients and vaccine response
timeFrame: at 3, 12 and 24 months after full block vaccination
measure: Correlation between proliferative T-cell response to mitogens and antigens and vaccine response
timeFrame: before and at 3 months after full block vaccination
measure: Correlation between innate immune response after ex vivo whole blood stimulation and vaccine response
timeFrame: before and at 3 months after full block vaccination
measure: proportion of HSCT recipients with adverse event after each vaccination including local and general reactions
timeFrame: 21 days after each vaccination
measure: ancillary study of cellular and humoral response to one dose of tetravalent inactivated influenza vaccine (IIV)
timeFrame: 4 weeks after influenza vaccination.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Florence ADER, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.