Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients (VaccHemInf)

Civil Hospices of Lyon

Status

Completed

Conditions

Hematopoietic Stem Cells

Vaccination

Treatments

Biological: immune biomarkers to evaluate vaccine response in HSCT recipients

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03659773

2017-A03230-53 (Other Identifier)

69HCL17_0769

Details and patient eligibility

About

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.

Enrollment

152 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.