Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285259
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2006-01-30
Brief Title:
Cytomegalovirus CMV Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant HCT
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 2 Clinical Trial to Evaluate the Safety Immunogenicity and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic Matched Hematopoietic Cell Transplant HCT
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to evaluate a CMV vaccine given to related donorrecipient pairs donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation and CMV-seropositive recipient-only subjects related or unrelated to determine incidence rates of CMV infection disease and other complications from immunosuppression andor transplantation The outcomes for the groups receiving CMV vaccine will be compared to the outcomes for the group that received the placebo vaccine to see if there is a clinical benefit For this trial donors and recipients must have matched HLA genotype matched at 56 or 66 HLA loci
Detailed Description:
This study was run by Vical and the record was transferred to Astellas on 182013
Trial will enroll up to 240 subjects 160 recipients and 80 donors Qualified donors andor CMV-seropositive recipients donorrecipient pairs or recipient-only subjects will be assigned randomly to receive either a CMV vaccine or a placebo vaccine Donors will receive 3 vaccines prior to donation and recipients will receive 1 vaccine pretransplant and up to three vaccines posttransplant Recipients will be followed for up to 1 year after transplant to evaluate the safety of the vaccine and to see if there is a clinical benefit in the group that received the CMV vaccine The incidence rates of CMV infection disease and other complications from immunosuppression andor transplantation will be studied
Trial will enroll up to 240 subjects 160 recipients and 80 donors Qualified donors andor CMV-seropositive recipients donorrecipient pairs or recipient-only subjects will be assigned randomly to receive either a CMV vaccine or a placebo vaccine Donors will receive 3 vaccines prior to donation and recipients will receive 1 vaccine pretransplant and up to three vaccines posttransplant Recipients will be followed for up to 1 year after transplant to evaluate the safety of the vaccine and to see if there is a clinical benefit in the group that received the CMV vaccine The incidence rates of CMV infection disease and other complications from immunosuppression andor transplantation will be studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None