Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants: Effect of Timing of Vaccination After Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
University of Colorado Hospital
RECRUITING
Aurora
Contact Information
Primary
Tori Rutherford, RN BSN
tori.rutherford@childrenscolorado.org
303-724-2454
Time Frame
Start Date: 2023-10-24
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 55
Treatments
Experimental: 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).
Experimental: 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).
Experimental: ≥ 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).
Related Therapeutic Areas
Sponsors
Collaborators: GlaxoSmithKline
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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