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)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01229267
First received: October 25, 2010
Last updated: July 27, 2016
Last verified: July 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Herpes Zoster |
Biological: V212 Biological: Matching 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: 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) |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Incidence of herpes zoster (HZ) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]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:
- 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 (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 3 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: Onset of HZ rash up to 6-month follow-up ] [ 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 greater than or equal to 90 days after the onset of the HZ rash
| Enrollment: | 1257 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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More Information
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01229267 History of Changes |
| Other Study ID Numbers: | V212-001 |
| Study First Received: | October 25, 2010 |
| Last Updated: | July 27, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 29, 2016