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Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy
Sponsor: Insel Gruppe AG, University Hospital Bern
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2023-11-14
Completion Date
2026-12
Last Updated
2024-03-27
Healthy Volunteers
No
Interventions
Vaccines 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