CompletedNot Applicable

Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

France152 participantsStarted 2018-04-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Trial details

NCT IDNCT03659773

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-21