Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
ConditionShingles
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorLoyola University
About this trial
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
≥ 12 months and ≤ 36 months post-AlloSCT
Donor sources: matched related, matched unrelated, cord blood
Any malignant hematological disease including acute leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative disorders.
Disqualifiers
Patients who had zoster after an allogeneic transplant and prior to enrollment
Patients who are currently pregnant
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the recombinant zoster vaccine, Shingrix, or other agents used in study.
Patients who have had a relapse of their primary hematological disease
Trial design
Design model
Single group
Treatments tested in this trial
Shingrix
DrugShingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ShingrixExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cell mediated and humoral immune response
Time frame
Measured one month following eh last dose of vaccine receivedSponsors and contacts
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Source ClinicalTrials.gov