- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02329457
VZV Vaccine for Hematopoietic Stem Cell Transplantation (VZIDST)
Efficacy and Safety of a Novel Intradermal Live-attenuated Varicella Zoster Vaccine in Hematopoietic Stem Cell Transplantation Donors: a Randomized Double Blind Placebo-controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Hematopoietic stem cell transplantation (HSCT) is well-established therapy for patients with malignant hematological diseases. Varicella zoster virus (VZV) reactivation, clinically manifested as herpes zoster (HZ), is a major complication that affects up to 50% of patients. Most patients will require hospitalization. Despite treatment with high dose acyclovir, patients may develop severe complications including the disabling postherpetic neuralgia, corneal ulceration, viral dissemination and secondary bacterial infection. The median onset of infection is the fifth month following transplantation, with 91% of cases occurring within the first year. Direct vaccination of transplants recipients with subcutaneous live-attenuated VZVv before transplantation and up to one year after transplantation is contraindicated. A small prospective non-randomized study has demonstrated that subcutaneous vaccination for donors before HSCT may offer some protection against VZV reactivation in the recipients. Recently, dose-sparing influenza vaccine delivered via a novel intradermal microneedle has been shown to elicit a good immunogenic response in both healthy and elderly subjects. We sought to assess the efficacy and safety of the novel intradermal live-attenuated VZVv in sibling donors undergoing HSCT.
We plan to enroll 160 pairs of adult donors and patients who undergo allogeneic HLA matched sibling HSCT in this prospective randomized double-blind placebo-controlled trial over a period of 3 years. Enrolled donors and patients will be randomized into 4 groups: Group 1: intradermal full dose live-attenuated VZVv; Group 2: subcutaneous full dose live-attenuated VZVv; Group 3: intradermal 0.9% normal saline as control; Group 4: subcutaneous 0.9% normal saline as the second control
All vaccines will be given to the donors within 28 days before HSCT. All intradermal vaccines will be given via a microneedle syringe. Both the investigators and participants will be blinded to the randomization process. The primary end point is the occurrence of HZ in the patients within 12 months of transplantation. The secondary end points are the safety and immunological response in the patients and donors.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Hong Kong, Hong Kong
- Ivan Hung
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- patients undergoing allogeneic hemopoietic stem cell transplant
- HLA identical sibling donors
- participants willing to provide written informed consents
Exclusion Criteria:
- history of zoster in the 12 months prior to transplantation
- exposure to VZV within 4 weeks of transplantation
- neomycin sensitivity
- sensitivity to any components of the zoster vaccine
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: ID varicella zoster vaccine (VZVv) group
intradermal 0.65 mL Zostavax
|
varicella zoster vaccine
|
Aktiv komparator: SC VZVv group
subcutaneous 0.65 mL Zostavax
|
varicella zoster vaccine
|
Placebo komparator: ID NS Group
intradermal 0.65 mL normal saline
|
normal saline placebo vaccine
|
Placebo komparator: SC NS Group
subcutaneous 0.65 mL normal saline
|
normal saline placebo vaccine
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Herpes Zoster Reactivation
Tidsramme: 12 months post transplantation
|
Incidence of herpes zoster in stem-cell transplant recipients
|
12 months post transplantation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Immunological response in recipients
Tidsramme: 30, 90, 180 and 360 days post transplantation
|
Geometric mean concentration of anti-VZV antibody (IU/mL)
|
30, 90, 180 and 360 days post transplantation
|
Immunological response in donors
Tidsramme: 30, 90, 180 and 360 days post transplantation
|
Geometric mean concentration of anti-VZV antibody (IU/mL)
|
30, 90, 180 and 360 days post transplantation
|
Adverse reaction
Tidsramme: 21 days after vaccination
|
Rate of adverse reaction in donors after vaccination
|
21 days after vaccination
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Hata A, Asanuma H, Rinki M, Sharp M, Wong RM, Blume K, Arvin AM. Use of an inactivated varicella vaccine in recipients of hematopoietic-cell transplants. N Engl J Med. 2002 Jul 4;347(1):26-34. doi: 10.1056/NEJMoa013441.
- Leung AY, Chow HC, Kwok JS, Lui CK, Cheng VC, Yuen KY, Lie AK, Liang R. Safety of vaccinating sibling donors with live-attenuated varicella zoster vaccine before hematopoietic stem cell transplantation. Bone Marrow Transplant. 2007 Jun;39(11):661-5. doi: 10.1038/sj.bmt.1705673. Epub 2007 Apr 9.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HKU 11-174
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Varicella Zoster Infection
-
Universidad del DesarrolloFullførtHealthcare Associated InfectionChile
-
Imelda Hospital, BonheidenFullførtHealthcare Associated InfectionBelgia
-
Centre Hospitalier Universitaire de NīmesRekrutteringEldre | Healthcare Associated InfectionFrankrike
-
Centre Hospitalier Universitaire, AmiensFullførtHealthcare Associated Infection | IglerFrankrike
-
Johns Hopkins UniversityFullførtHealthcare Associated Infection | Multiresistente organismer
-
University of PennsylvaniaFullførtAntimikrobiell resistensForente stater, Botswana
-
University of Maryland, BaltimoreVA Office of Research and DevelopmentFullførtMenneskelig mikrobiomForente stater
-
Universidad Autonoma de Nuevo LeonUkjentHelsetilknyttede infeksjoner
-
Children's Hospital Medical Center, CincinnatiAvsluttetAllogen hematopoetisk celletransplantasjonForente stater
-
Central Hospital, Nancy, FranceHar ikke rekruttert ennåHealthcare Associated Infection | Antibiotika
Kliniske studier på Zostavax
-
Merck Sharp & Dohme LLCFullført
-
Merck Sharp & Dohme LLCFullført
-
University of ZurichTilbaketrukket
-
University of SydneyFullført
-
University of Colorado, DenverNational Institute of Allergy and Infectious Diseases (NIAID)Fullført
-
Seoul National University HospitalFullførtHerpes ZosterKorea, Republikken
-
Seoul National University HospitalFullført
-
Merck Sharp & Dohme LLCFullført
-
University of South FloridaMerck Sharp & Dohme LLCAvsluttetX-bundet agammaglobulinemi | Spesifikk antistoffmangel | Vanlig variabel immunsviktForente stater