Herpes zoster (HZ).
Conditions
Interventions
Product Name: Heat Treated Zoster Vaccine
Pharmaceutical Form: Suspension for injection
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 0.65-
Pharmaceutical form o
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is =18 years of age on day of signing informed consent. Patient has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for =30 years or if patient is ?30 years old, attended primary or secondary school in a country with endemic VZV infection. Patient is scheduled to undergo autologous HCT for treatment of lymphoma or non-lymphoma cancer (i.e., any other malignancy) within 60 days of enrolment. Patient is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose, as indicated by at least one “yes” answer to the following questions: Patient is a male. Patient is a surgically sterilized female. Patient is a postmenopausal female. Postmenopausal status is defined as =43 years of age and 1) no menses for >1 year but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient has a history of hypersensitivity reaction to any vaccine component, including gelatin or neomycin (a history of contact dermatitis to neomycin is not a criterion for study exclusion). Patient has a prior history of HZ within 1 year of enrollment. Patient has a prior history of receipt of any varicella or zoster vaccine. Patient has a cancer other than Hodgkin’s lymphoma and has had more than 2 relapses of the underlying cancer. Patient is expected to undergo a tandem transplant procedure. Patient is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 6 months from last vaccination dose. Patient has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4. Patient has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Dose 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of the heat-treated varicella-zoster vaccine (VZV) vaccine in recipients of autologous hematopoietic cell transplant (HCT). To assess the impact of the heat-treated VZV vaccine on the development of HZ following autologous HCT ;Secondary Objective: To assess the impact of the heat-treated VZV vaccine on the development of postherpetic neuralgia (PHN) [defined as a worst pain in the last 24 hours of 3 or greater (on a 0-to-10 scale) on the Zoster Brief Pain Inventory (ZBPI)] that persists or appears more than 90 days after the onset of the HZ rash] post-autologous HCT. ;Primary end point(s): The primary clinical efficacy endpoint will be the incidence of HZ. Blood samples will be collected from all patients to test for VZV-specific antibody responses as measured by gpELISA prior to Dose 1 (the pre-HCT dose), as well 60 days (prior to Dose 3), 90 days (prior to Dose 4), 120 days, 6 months, 12 months, 18 months and 24 months after HCT and annually thereafter until study completion. The primary safety endpoint of the study will be safety and tolerability following all 4 vaccine doses and will be based on the incidence of vaccine-related serious adverse experiences observed during the four 28-day follow-up periods in each vaccination group. | — |
Countries
Czech Republic, France, Germany
Outcome results
None listed