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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 randomized, double-blind, placebo-controlled study to assess the safety and
tolerability of V212 when administered to adults with solid tumor malignancy (STM) or
hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes
zoster (HZ) in adults with STM or HM, as compared to placebo.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion criteria;
- Participant has been diagnosed with an STM or HM and is not likely to undergo
hematopoietic cell transplant (HCT) and:
- Participant is =18 years of age and receiving a cytotoxic or immunosuppressive
chemotherapy regimen
- Participant is = 50 years of age with a hematologic malignancy that is not in
remission, whether on therapy or not
- Participant has a life expectancy = 12 months.
- Participant has prior history of varicella or antibodies to VZV due to exposure to
the disease in a country where the disease is common.
Exclusion criteria:
- Participant has a history of allergic reaction to any vaccine component (including
gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.
- Participant has a prior history of HZ within 1 year of enrollment.
- Participant has received or is expected to receive any varicella or non-study zoster
vaccine.
- Participant is currently receiving or expected to receive long-term antiviral
prophylaxis (>4 weeks duration) with activity against herpes simplex virus (HSV), VZV
or cytomegalovirus (CMV)
- Participant is pregnant or breastfeeding or expecting to conceive within the period
of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
- Participant has had any live virus vaccine administered or scheduled in the period
from 4 weeks prior to Dose 1 through 28 days post vaccination dose 4
- Participant has had inactivated vaccine administered or scheduled within the period
from 7 days prior to, through 7 days following, any dose of study vaccine.
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Who cannot enter the trial
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Inclusion criteria;
- Participant has been diagnosed with an STM or HM and is not likely to undergo
hematopoietic cell transplant (HCT) and:
- Participant is =18 years of age and receiving a cytotoxic or immunosuppressive
chemotherapy regimen
- Participant is = 50 years of age with a hematologic malignancy that is not in
remission, whether on therapy or not
- Participant has a life expectancy = 12 months.
- Participant has prior history of varicella or antibodies to VZV due to exposure to
the disease in a country where the disease is common.
Exclusion criteria:
- Participant has a history of allergic reaction to any vaccine component (including
gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.
- Participant has a prior history of HZ within 1 year of enrollment.
- Participant has received or is expected to receive any varicella or non-study zoster
vaccine.
- Participant is currently receiving or expected to receive long-term antiviral
prophylaxis (>4 weeks duration) with activity against herpes simplex virus (HSV), VZV
or cytomegalovirus (CMV)
- Participant is pregnant or breastfeeding or expecting to conceive within the period
of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
- Participant has had any live virus vaccine administered or scheduled in the period
from 4 weeks prior to Dose 1 through 28 days post vaccination dose 4
- Participant has had inactivated vaccine administered or scheduled within the period
from 7 days prior to, through 7 days following, any dose of study vaccine.
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What will happen
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Biological; V212; V212 viral antigen for HZ, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.; V212 Arm; Inactivated Varicella-Zoster (VZV) vaccine; Biological; Placebo; Vaccine stabilizer for V212 with no virus antigen, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.; Placebo Arm
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Primary aim
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The number of HZ cases per 1000 person-years of follow-up; The number of participants experiencing serious adverse events
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Secondary Aim
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The number of HZ cases per 1000 person-years of follow-up in the STM population; From study enrollment up to approximately 5 years; No; The number of HZ cases per 1000 person-years of follow-up in the HM population; From study enrollment up to approximately 5 years; No; 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 is 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 5 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); From HZ onset through the end of the 6 month HZ-follow-up period; 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 >= 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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