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 Participants Undergoing Hematopoietic Cell Transplants (HCTs) (Study No. V212-001 AM4)

Study Description

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Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Herpes Zoster	Biological: V212; Biological: Matching placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1257 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)
Study Start Date :	November 2010
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: V212; V212 (inactivated VZV)	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.; Other Name: Inactivated Varicella-Zoster (VZV) vaccine
Placebo Comparator: Placebo; Matching placebo	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.

Outcome Measures

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Primary Outcome Measures :

1. Incidence of herpes zoster (HZ) [ Time Frame: Approximately 3 years ]
   Incidence is defined as the number of HZ cases per 1000 person-years of follow-up from study enrollment to the end of study.

Secondary Outcome Measures :

1. Incidence of moderate to severe HZ-associated pain [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ]
   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]),
2. Incidence of HZ complications [ Time Frame: Approximately 3 years ]
   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.
3. Incidence of postherpetic neuralgia (PHN) [ Time Frame: Onset of HZ rash up to 6-month follow-up ]
   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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01229267 History of Changes
Other Study ID Numbers:	V212-001
First Posted:	October 27, 2010
Last Update Posted:	July 28, 2016
Last Verified:	July 2016

Keywords provided by Merck Sharp & Dohme Corp.:

Herpes zoster; vaccine; herpes zoster-related complications; immunocompromised; autologous hematopoietic cell transplants

Additional relevant MeSH terms:

Herpes Zoster; Herpesviridae Infections; DNA Virus Infections; Virus Diseases	Vaccines; Immunologic Factors; Physiological Effects of Drugs