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Health Condition(s) or Problem
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Herpes Zoster
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Lay Summary
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This is a study to determine whether investigational V212 reduces the incidence of herpes
zoster (HZ) compared to placebo when administered to recipients of autologous hematopoietic
cell transplants (HCT).
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Men and women at least 18 years of age
- 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 participant is <30 years old, attended primary or secondary school in a country
with endemic VZV infection.
- Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of
enrollment
- Is highly unlikely to conceive during the time period starting 2 weeks prior to
enrollment through 6 months from last vaccination dose
- Female participants of childbearing potential must have a negative serum or urine
pregnancy test.
Exclusion Criteria:
- History of hypersensitivity reaction to any vaccine component
- Prior history of herpes zoster within 1 year of enrollment
- Prior receipt of any varicella or zoster vaccine
- More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma
may have had more than 2 relapses)
- Expectation of tandem transplant procedure
- Is expected to receive >6 months (>180 days) of prophylactic antiviral therapy
post-HCT.
- Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks
prior to enrollment through 6 months from last vaccination dose.
- 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.
- 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 Doses 1 through 4.
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Who cannot enter the trial
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Inclusion Criteria:
- Men and women at least 18 years of age
- 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 participant is <30 years old, attended primary or secondary school in a country
with endemic VZV infection.
- Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of
enrollment
- Is highly unlikely to conceive during the time period starting 2 weeks prior to
enrollment through 6 months from last vaccination dose
- Female participants of childbearing potential must have a negative serum or urine
pregnancy test.
Exclusion Criteria:
- History of hypersensitivity reaction to any vaccine component
- Prior history of herpes zoster within 1 year of enrollment
- Prior receipt of any varicella or zoster vaccine
- More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma
may have had more than 2 relapses)
- Expectation of tandem transplant procedure
- Is expected to receive >6 months (>180 days) of prophylactic antiviral therapy
post-HCT.
- Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks
prior to enrollment through 6 months from last vaccination dose.
- 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.
- 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 Doses 1 through 4.
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What will happen
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Biological; V212; 0.5-mL subcutaneous injection administered ~30days (60 to 5 days) prior to HCT. Doses 2 through 4 will be administered 30, 60 and 90 days post-HCT.; V212; Inactivated Varicella-Zoster (VZV) vaccine; Biological; Matching placebo; 0.5-mL subcutaneous injection administered ~30days (60 to 5 days) prior to HCT. Doses 2 through 4 will be administered 30, 60 and 90 days post-HCT.; Placebo
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Primary aim
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Incidence of herpes zoster (HZ)
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Secondary Aim
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Incidence of moderate to severe HZ-associated pain; From HZ onset through the end of the 6 month HZ-follow-up period; No; Moderate to severe HZ-associated pain (defined as 2 or more occurrences of a score of 3 or greater (0-to-10 scale) on the Zoster Brief Pain Inventory [ZBPI]),; Incidence of HZ complications; Approximately 3 years; No; HZ complications defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.; Incidence of postherpetic neuralgia (PHN); Onset of HZ rash up to 6-month follow-up; No; Postherpetic neuralgia (PHN) is defined as a worst pain score [in the last 24 hours] of 3 or greater [0-to-10 scale] on the Zoster Brief Pain Inventory (ZBPI) that persists or appears greater than or equal to 90 days after the onset of the HZ rash
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Hoddesdon
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