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RecruitingNCT06333275

Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

80 participants

Start Date

Nov 14, 2023

Study Type

OBSERVATIONAL

Conditions

Vaccine Immunity in CAR-T Cell Therapy Recipients

Summary

The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are: * Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens * Are current re-vaccination recommendations sufficient in restoring vaccine-protection * Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual * Do clinical or immunological factors predict vaccine response after CAR-T cell therapy

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patient ≥ 18 years old
  • Suffering from a B-cell malignancy (B-cell acute lymphoblastic leukemia (ALL), B-cell non-hodgkin lymphoma (NHL), Follicular lymphoma (FL), Mantle Cell Lymphoma (MCL), Multiple myeloma (MM))
  • Planned for a CAR-T cell therapy
  • Provided written informed consent

Exclusion Criteria3

  • Previous or already started CAR-T cell therapy
  • \< 18 years old
  • Lack of consent
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Interventions

BIOLOGICALVaccines against: Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b, varicella and measles

First immunization course (6±1 months post CAR-T treatment): 1. Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b (as by the Swiss guidelines\[FOPH\] all of these are administered in one combined vaccine; INFANRIX DTPa-IPV+Hib Inj Susp®; GlaxoSmithKline) 2. Hepatitis B (Engerix B®, GlaxoSmithKline) 3. 13-valent Streptococcus pneumonia vaccine (Prevenar-13®; Pfizer) 4. Herpes zoster vaccine in patients with documented prior seropositivity or known varicella-infection in patient history (as by The Swiss guidelines; Shingrix®; GlaxoSmithKline) 5. Tick-borne encephalitis (as by The Swiss guidelines; FSME Immun CC®; Pfizer or Encepur N®, BavarianNordic; these vaccines can be used interchangeably) Second immunization course (12±1 months post CAR-T treatment): 1. Mumps, measles, rubella (Priorix®, GlaxoSmithKline) 2. Varicella zoster vaccine (as by guidelines; Varilrix®, GlaxoSmithKline) If seronegative/patient history negative

Locations(1)

University Hospital Bern

Bern, Switzerland

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NCT06333275