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

NCT06333275 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-03-27

No results posted yet for this study

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

Conditions

  • Vaccine Immunity in CAR-T Cell Therapy Recipients

Interventions

BIOLOGICAL

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Christine Thurnheer Zürcher, PD, MD · University Hospital Bern, Switzerland

  • Cédric Hirzel, PD, MD · University Hospital Bern, Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333275 on ClinicalTrials.gov