A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011 AM1) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT01254630

Purpose

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.

Condition	Intervention	Phase
Herpes Zoster	Biological: V212 Biological: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients With Solid Tumor or Hematologic Malignancy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chickenpox Shingles

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

The number of HZ cases per 1000 person-years of follow-up [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
The number of participants experiencing serious adverse events [ Time Frame: From vaccination day 1 through 28 days post vaccination dose 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The number of HZ cases per 1000 person-years of follow-up in the STM population [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
The number of HZ cases per 1000 person-years of follow-up in the HM population [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
Incidence of moderate to severe HZ-associated pain [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: 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 [ Time Frame: Approximately 5 years ] [ Designated as safety issue: 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) [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: 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.

Estimated Enrollment:	5264
Study Start Date:	June 2011
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: V212 Arm 0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen.	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. Other Name: Inactivated Varicella-Zoster (VZV) vaccine
Placebo Comparator: Placebo Arm 0.5 mL SC injection per dose, in a four dose regimen.	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 that does not include an anti-CD20 monoclonal antibody
Participant is ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not, and is not expected to need anti-CD20 monoclonal antibody therapy within 3 months prior to enrollment on this study through 28 days after receiving vaccination dose 4.
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 receiving or expected to receive a chemotherapy regimen containing an anti-CD20 monoclonal antibody
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254630

Contacts

Contact: Toll Free Number

1-888-577-8839

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Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01254630 History of Changes
Other Study ID Numbers:	V212-011
Study First Received:	December 3, 2010
Last Updated:	May 11, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Herpes zoster
vaccine
solid tumor malignancy

hematologic malignancy
immunocompromised
herpes-zoster-related complications

Additional relevant MeSH terms:

Neoplasms
Herpes Zoster
Hematologic Neoplasms
Herpesviridae Infections

DNA Virus Infections
Virus Diseases
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 23, 2012