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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) (V212-001)

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ClinicalTrials.gov Identifier: NCT01229267
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Herpes Zoster
Interventions: Biological: V212
Biological: Matching placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult participants scheduled to undergo Autologous Hematopoietic Cell Transplant (auto-HCT) within 60 days were enrolled at 150 sties

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1323 participants were screened and 1257 were randomized. Twenty-seven randomized participants were removed from all analyses due to the identification of major Good Clinical Practice compliance issues at a single site.

Reporting Groups
  Description
V212 Consistency Lot 1 Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
V212 Consistency Lot 2 Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
V212 Consistency Lot 3 Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
V212 High Antigen Lot Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
Placebo Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.

Participant Flow:   Overall Study
    V212 Consistency Lot 1   V212 Consistency Lot 2   V212 Consistency Lot 3   V212 High Antigen Lot   Placebo
STARTED   189   184   187   106   564 
Received Vaccination 1   188   180   186   104   556 
Received Vaccination 2   171   163   168   94   511 
Received Vaccination 3   163   155   160   89   491 
Received Vaccination 4   155   149   149   87   477 
COMPLETED   108   102   101   71   344 
NOT COMPLETED   81   82   86   35   220 
Adverse Event                4                6                3                2                10 
Death                40                37                35                13                103 
Withdrawal by Subject                23                22                32                14                59 
Protocol Violation                0                1                0                0                0 
Progressive disease                0                0                0                0                1 
Physician Decision                8                11                8                3                25 
Lost to Follow-up                6                5                8                3                22 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 1257 participants were enrolled. Twenty-seven participants were excluded from the analysis due to Good Clinical Practice non-compliance at a single site.

Reporting Groups
  Description
V212 Consistency Lot 1 Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
V212 Consistency Lot 2 Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
V212 Consistency Lot 3 Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
V212 High Antigen Lot Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
Placebo Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
Total Total of all reporting groups

Baseline Measures
   V212 Consistency Lot 1   V212 Consistency Lot 2   V212 Consistency Lot 3   V212 High Antigen Lot   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 189   184   187   106   564   1230 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.6  (12.8)   54.2  (12.6)   53.4  (12.4)   54.3  (12.2)   54.1  (12.2)   54.1  (12.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      69  36.5%      73  39.7%      61  32.6%      48  45.3%      204  36.2%      455  37.0% 
Male      120  63.5%      111  60.3%      126  67.4%      58  54.7%      360  63.8%      775  63.0% 
Age 
[Units: Participants]
Count of Participants
           
From 18-49 years      53  28.0%      51  27.7%      54  28.9%      29  27.4%      159  28.2%      346  28.1% 
From 50-59 years      56  29.6%      60  32.6%      64  34.2%      40  37.7%      187  33.2%      407  33.1% 
From 60-69 years      63  33.3%      61  33.2%      65  34.8%      31  29.2%      188  33.3%      408  33.2% 
From 70-79 years      17   9.0%      12   6.5%      4   2.1%      6   5.7%      30   5.3%      69   5.6% 
Intended duration of antiviral prophylaxis 
[Units: Participants]
Count of Participants
           
≤3 months post auto-HCT      80  42.3%      80  43.5%      79  42.2%      43  40.6%      255  45.2%      537  43.7% 
>3 to ≤6 months post auto-HCT      109  57.7%      103  56.0%      108  57.8%      63  59.4%      308  54.6%      691  56.2% 
Not reported      0   0.0%      1   0.5%      0   0.0%      0   0.0%      1   0.2%      2   0.2% 


  Outcome Measures

1.  Primary:   Incidence of Confirmed Herpes-Zoster   [ Time Frame: Up to approximately 5 years ]

2.  Primary:   Percentage of Participants With One or More Serious Adverse Events   [ Time Frame: Up to 28 days after vaccination 4 (up to 118 days) ]

3.  Secondary:   Incidence of Moderate to Severe Herpes-Zoster-Associated Pain   [ Time Frame: Up to 6 months after onset of HZ (up to approximately 5 years) ]

4.  Secondary:   Incidence of Herpes-Zoster Complications   [ Time Frame: Up to 6 months after onset of HZ (up to approximately 5 years) ]

5.  Secondary:   Incidence of Postherpetic Neuralgia   [ Time Frame: Up to 6 months after the onset of HZ rash (up to approximately 5 years) ]

6.  Other Pre-specified:   Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event   [ Time Frame: Up to 28 days after vaccination 4 (up to 118 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01229267     History of Changes
Other Study ID Numbers: V212-001
2010-020150-34 ( EudraCT Number )
V212-001 ( Other Identifier: Merck Protocol Number )
First Submitted: October 25, 2010
First Posted: October 27, 2010
Results First Submitted: April 16, 2018
Results First Posted: July 2, 2018
Last Update Posted: July 2, 2018