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Shingrix u biorców przeszczepów allogenicznych (Allo)

1 października 2026 zaktualizowane przez: University of Colorado, Denver

Bezpieczeństwo i immunogenność szczepionki Shingrix podawanej biorcom allogenicznych przeszczepów komórek macierzystych krwi obwodowej i krwi pępowinowej: wpływ czasu szczepienia po przeszczepie

This research is designed to determine if the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant (allo-SCT). Specifically, it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a phase II, single center, prospective, unblinded, immunogenicity and safety study. It is anticipated that enrollment will take approximately 12 months. Duration of participation for study subjects is approximately 1 year. During this interval, participants will continue to receive clinical care from the BMT center, which will ensure retention.

Participants will be recruited at their routine clinic visits, which take place every 6 months post-transplantation, or will be recruited by phone. Participants will be consented by study personnel in coordination with the BMT health care providers and subsequently followed in Dr. Levin's Vaccine Research Clinic, where they will also receive the 3rd dose of vaccine.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

55

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 79 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Allo-SCT recipients being age 18 - 79 years at time of allo-SCT.

  • Written informed consent being obtained from the subject

  • Two doses of RZV, separated by 2 to 6 months, administered at least 1 year after allo-SCT.

  • Enrollment at >/= 18 months after second dose of Shingrix.

  • Female subjects of childbearing potential (FOCBP) enrolled in the study only if they:

    • have practiced adequate contraception for 30 days prior to vaccination with any dose of zoster vaccine and
    • have a negative pregnancy test on the day of each dose of zoster vaccine and
    • agree to continue adequate contraception during the vaccination period and for 2 months after receipt of the vaccine.

  • Investigator belief that the participant will comply with the requirements of the protocol

Exclusion Criteria:

  • Active Graft Versus Host Disease (aGVHD) at the time of enrollment and receipt of the third dose of RZV
  • Having received ≥20 mg prednisone for more than 2 weeks (or equivalent) in the 8 weeks preceding enrollment.
  • Receiving any significant immunosuppressive therapy other than for graft maintenance, in the opinion of the investigator.
  • Having received a live attenuated vaccine within the last 4 weeks, or inactivated vaccine in the last 2 weeks, prior to enrollment.
  • Having a history of HZ after the administration of the primary 2-dose RZV immunization regimen.
  • Pregnancy or breastfeeding
  • Receiving investigational drugs from 30 day before enrollment or planned during the study
  • Inability of participants unable to comply with the study schedule in the opinion of the investigator

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 1-<2 years post stem cell transplant

At Visit 1 participants will be given information about the nature of HZ and its recognition and given a questionnaire for completion should they develop HZ during the study. They will also be asked to contact the study team if they develop HZ so that further evaluation of potential HZ is completed and the details of the event recorded. A swab of an active lesion or crust from a dried lesion will be obtained for VZV PCR. A participant who develops HZ will be asked to complete the questionnaire weekly for 4 weeks and then at 8 and 12 weeks. In addition, the subject will be asked about pain medications taken during the episode. Information on HZ incidence will be supplemented from the clinic medical records and the electronic medical records. Subjects will be followed for 1 year after enrollment for the occurrence of HZ and of post-herpetic neuralgia (PHN).
Lek: Zoster Vaccine Recombinant

Injection

Inne nazwy:
  • Shingrix
Eksperymentalny: 2-<3 years post stem cell transplant

At Visit 1 participants will be given information about the nature of HZ and its recognition and given a questionnaire for completion should they develop HZ during the study. They will also be asked to contact the study team if they develop HZ so that further evaluation of potential HZ is completed and the details of the event recorded. A swab of an active lesion or crust from a dried lesion will be obtained for VZV PCR. A participant who develops HZ will be asked to complete the questionnaire weekly for 4 weeks and then at 8 and 12 weeks. In addition, the subject will be asked about pain medications taken during the episode. Information on HZ incidence will be supplemented from the clinic medical records and the electronic medical records. Subjects will be followed for 1 year after enrollment for the occurrence of HZ and of post-herpetic neuralgia (PHN).
Lek: Zoster Vaccine Recombinant

Injection

Inne nazwy:
  • Shingrix
Eksperymentalny: ≥ 3 years post stem cell transplant

At Visit 1 participants will be given information about the nature of HZ and its recognition and given a questionnaire for completion should they develop HZ during the study. They will also be asked to contact the study team if they develop HZ so that further evaluation of potential HZ is completed and the details of the event recorded. A swab of an active lesion or crust from a dried lesion will be obtained for VZV PCR. A participant who develops HZ will be asked to complete the questionnaire weekly for 4 weeks and then at 8 and 12 weeks. In addition, the subject will be asked about pain medications taken during the episode. Information on HZ incidence will be supplemented from the clinic medical records and the electronic medical records. Subjects will be followed for 1 year after enrollment for the occurrence of HZ and of post-herpetic neuralgia (PHN).
Lek: Zoster Vaccine Recombinant

Injection

Inne nazwy:
  • Shingrix

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant
Ramy czasowe: 1 Year

To compare gE-specific CMI immune response of Cohort 1 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment across 3 groups defined by the time of vaccination after transplantation.
1 Year
Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients
Ramy czasowe: 1 Year

To compare gE-specific CMI immune response of Cohort 1 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment to immunologic data previously determined in prior studies of immune-competent older recipients of RZV (age ≥50 years).
1 Year
Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 1
Ramy czasowe: 1 Year

Document all adverse events after 3rd dose of Shingrix.
1 Year
Compare gE-specific CMI via blood draw in Cohort 1 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose
Ramy czasowe: 1 Year

To compare gE-specific CMI in Cohort 1 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose.
1 Year
Compare gE-specific CMI via blood draw in Cohort 1 recipients at 365 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose
Ramy czasowe: 1 Year

To compare gE-specific CMI in Cohort 1 recipients at 365 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
1 Year
Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant
Ramy czasowe: 1 Year

To compare gE-specific CMI immune response of Cohort 2 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment across 3 groups defined by the time of vaccination after transplantation.
1 Year
Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients
Ramy czasowe: 1 Year

To compare gE-specific CMI immune response of Cohort 1 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment to immunologic data previously determined in prior studies of immune-competent older recipients of RZV (age ≥50 years).
1 Year
Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 2
Ramy czasowe: 1 Year

Document all adverse events after 3rd dose of Shingrix.
1 Year
Compare gE-specific CMI via blood draw in Cohort 2 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose
Ramy czasowe: 1 Year

To compare gE-specific CMI in Cohort 2 recipients at 30-60 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
1 Year
Compare gE-specific CMI via blood draw in Cohort 2 recipients at 365 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose
Ramy czasowe: 1 Year

To compare gE-specific CMI in Cohort 2 recipients at 365 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
1 Year
Compare the immune response via blood draw of Cohort 3 prior to enrollment to ≥1 year post-transplant
Ramy czasowe: 1 Year

To compare gE-specific CMI immune response of Cohort 3 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment across 3 groups defined by the time of vaccination after transplantation.
1 Year
Compare the immune response via blood draw of Cohort 3 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients
Ramy czasowe: 1 Year

To compare gE-specific CMI immune response of Cohort 3 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment to immunologic data previously determined in prior studies of immune-competent older recipients of RZV (age ≥50 years).
1 Year
Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 3
Ramy czasowe: 1 Year

Document all adverse events after 3rd dose of Shingrix.
1 Year
Compare gE-specific CMI via blood draw in Cohort 3 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose
Ramy czasowe: 1 Year

To compare gE-specific CMI in Cohort 3 recipients at 30-60 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
1 Year
Compare gE-specific CMI via blood draw in Cohort 3 recipients at 365 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose
Ramy czasowe: 1 Year

To compare gE-specific CMI in Cohort 3 recipients at 365 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
1 Year
Compare gE-specific CMI via blood draw at 30-60 days after a 3rd dose of Shingrix in allo-SCT with responses of immune-competent older adults at the same time point after the dose of Shingrix
Ramy czasowe: 1 Year

To compare gE-specific CMI at 30-60 days after a 3rd dose of Shingrix in allo-SCT with responses of immune-competent older adults at the same time point after the dose of Shingrix
1 Year
Compare gE-specific CMI via blood draw at 365 days after a 3rd dose of Shingrix in allo-SCT with responses of immune-competent older adults at the same time points after the 2nd dose of Shingrix
Ramy czasowe: 1 Year

To compare gE-specific CMI at 365 days after a 3rd dose of Shingrix in allo-SCT with responses of immune-competent older adults at the same time points after the 2nd dose of Shingrix.
1 Year

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after the administration of the primary 2-dose regimen
Ramy czasowe: 1 Year

To compare gE-specific antibody responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months after the 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months after the administration of the primary 2-dose regimen.
1 Year
Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of immune-competent adults at 1 year after the administration of the primary 2-dose regimen
Ramy czasowe: 1 Year

To compare gE-specific antibody responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune competent adults at 1-2 months and 1 year, respectively, after administration of the primary 2-dose regimen.
1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after administration of the primary 2-dose regimen
Ramy czasowe: 1 Year

To compare VZV-specific IL2 responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months and 1 year, respectively, after administration of the primary 2-dose regimen.
1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT primary immunization 1-2 months after 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months after administration of primary 2-dose response.
Ramy czasowe: 1 Year

To compare VZV-specific IL2 responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 18-30 months and 1 year, respectively, after administration of the primary 2-dose regimen.
1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1 year after administration of the primary 2-dose regimen.
Ramy czasowe: 1 Year

To compare VZV-specific IL2 responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months and 1 year, respectively, after administration of the primary 2-dose regimen.
1 Year
Compare the gE-specific T cell differentiation via blood draw in allo-SCT recipients before the 3rd dose of Shingrix to imune-competent adults
Ramy czasowe: 1 Year

To compare the gE-specific T cell differentiation in allo-SCT recipients before the 3rd dose of Shingrix with the immune profiles of immune-competent older adults before primary immunization regimen.
1 Year
Compare the gE-specific T cell differentiation via blood draw in allo-SCT recipients after the 3rd dose of Shingrix to immune-competent adults
Ramy czasowe: 1 Year

To compare the gE-specific T cell differentiation in allo-SCT recipients after the 3rd dose of Shingrix with the immune profiles of immune-competent older adults after the primary immunization regimen.
1 Year
Compare the gE-specific trained immunity profiles via blood draw in allo-SCT recipients before the 3rd dose of Shingrix with the profile of immune-competent adults
Ramy czasowe: 1 year

To compare the gE-specific trained immunity profiles in allo-SCT recipients before the 3rd dose of Shingrix with the immune profiles of immune-competent older adults before the primary immunization regimen.
1 year
Compare the gE-specific trained immunity profiles via blood draw in allo-SCT recipients after the 3rd dose of Shingrix with the profiles of immune-competent adults
Ramy czasowe: 1 year

To compare the gE-specific trained immunity profiles in allo-SCT recipients after the 3rd dose of Shingrix with the immune profiles of immune-competent older adults after the primary immunization regimen.
1 year
Determine the incidence of HZ in allo-SCT recipients who received 3 doses of Shingrix.
Ramy czasowe: 1 year

To assess the incidence of HZ in allo-SCT recipients who received 3 doses of Shingrix post-Tx as reported by patients.
1 year
Determine the severity of HZ via blood draw and patient dairy in allo-SCT recipients who received 3 doses of Shingrix.
Ramy czasowe: 1 year

To assess the incidence and severity of HZ in allo-SCT recipients who received 3 doses of Shingrix post-Tx as reported by patients.
1 year
Determine the predictive value of TTV titer via blood draw on the immunogenicity of the 3rd dose of Shingrix in allo-SCT
Ramy czasowe: 1 year

To assess the value of TTV titer on the immunogenicity in allo-SCT recipients who received 3 doses of Shingrix post-Tx as reported by patients.
1 year

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Colorado, Denver

Współpracownicy

GlaxoSmithKline

Śledczy

  • Główny śledczy: Myron Levin, MD, University of Colorado, Denver

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

24 października 2023

Zakończenie podstawowe (Szacowany)

20 stycznia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

28 lutego 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 marca 2023

Pierwszy wysłany (Rzeczywisty)

20 marca 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 22-0394.cc
  • NCI-2023-04097 (Inny identyfikator: CTRP)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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