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Virus Vaccine
Shingrix Vaccine for Bone Marrow Transplant Recipients (Allo Trial)
Phase 2
Recruiting
Led By Myron Levin, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Allo-SCT recipients being age 18 - 79 years at time of allo-SCT.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Allo Trial Summary
This trial will determine if a vaccine against shingles is safe and effective in people who have had stem cell transplants.
Who is the study for?
This trial is for adults aged 18-79 who've had an allogeneic stem cell transplant. They must be 1 year post-transplant and have received two doses of Shingrix vaccine. Women must use contraception and not be pregnant or breastfeeding. Excluded are those with active graft disease, recent high-dose steroids, other immunosuppressants, or vaccines.Check my eligibility
What is being tested?
The study tests the safety and immune response to the Shingrix vaccine in bone marrow transplant recipients. It examines if timing after transplantation affects immunity and whether an extra dose enhances protection.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar vaccines can cause injection site pain, muscle aches, fatigue, headache, shivering, fever, gastrointestinal symptoms.
Allo Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 79 years old and have received an allogeneic stem cell transplant.
Allo Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
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
+14 moreSecondary outcome measures
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.
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.
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
+9 moreAllo Trial Design
3Treatment groups
Experimental Treatment
Group I: ≥ 3 years post stem cell transplantExperimental Treatment1 Intervention
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).
Group II: 2-<3 years post stem cell transplantExperimental Treatment1 Intervention
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).
Group III: 1-<2 years post stem cell transplantExperimental Treatment1 Intervention
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).
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,471 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,780 Total Patients Enrolled
Myron Levin, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
6,492 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a live vaccine in the last 4 weeks or a killed vaccine in the last 2 weeks.I received my second Shingrix dose between 18 and 30 months ago.I am between 18 and 79 years old and have received an allogeneic stem cell transplant.I am a woman able to have children and agree to follow the study's birth control requirements.I am not on strong immune-weakening medicines, except for transplant care.You must use contraception during and after receiving the vaccine.You have practiced responsible contraception for at least 30 days prior to receiving any dose of zoster vaccine.You must take a pregnancy test prior to each dose of zoster vaccine, and the result should be negative.I currently have active Graft Versus Host Disease.I have been on a high dose of steroids for more than 2 weeks recently.You are currently pregnant or breastfeeding.I am not taking any experimental drugs and won't start any during the study.The subject has provided written consent.I received two doses of the RZV vaccine, 1 year after my stem cell transplant.You demonstrate a commitment to following the protocol as determined by the investigator.
Research Study Groups:
This trial has the following groups:- Group 1: 1-<2 years post stem cell transplant
- Group 2: 2-<3 years post stem cell transplant
- Group 3: ≥ 3 years post stem cell transplant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research consider individuals older than 55 years?
"This clinical trial is seeking individuals aged 18 and above, but below 79 years old."
Answered by AI
What are the eligibility criteria for this experiment?
"To be considered for this medical study, potential participants must have received a bone marrow transplant and lie between 18-79 years of age. The trial is currently open to 55 individuals in total."
Answered by AI
What risks may arise following a stem cell transplant in the first two years?
"The safety of stem cell transplant within 1 to 2 years has been rated a two, as there have been some case studies that demonstrate its security yet no efficacy data."
Answered by AI
Are there any vacancies to join this research study?
"The clinicaltrial.gov website does not list this trial as currently recruiting patients, however its original posting date is December 1st 2023 and it was most recently edited on March 17th 2023. Nonetheless, there are 49 other trials actively searching for participants at the moment."
Answered by AI
What are the fundamental aims of this research endeavor?
"According to GlaxoSmithKline, the study's main outcome will be tracked over a 12 month period and involves comparing immune responses between trial participants who have received Shingrix and those of immunocompetent adults. Additionally, secondary objectives include measuring gE-specific antibody responses 18-30 months after primary immunization with Shingrix compared to 1 year after 2 doses; VZV-specific IL2 response measured post 3rd dose versus pre two dose administration; as well as comparing VZV-specific IL2 response at 1-2 months following third dose among allogeneic stem cell transplant recipients against older individuals"
Answered by AI
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