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A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00535236
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : April 16, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation 4 (CD4) cell count ≤200 cells/mm^3, participants with solid tumor malignancy (STM; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine will elicit significant VZV-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants with STM, and participants with HM. The primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic HCT groups.

Condition or disease Intervention/treatment Phase
Herpes Zoster Herpes Zoster-related Complications Biological: V212 Biological: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults
Actual Study Start Date : November 2, 2007
Actual Primary Completion Date : January 25, 2010
Actual Study Completion Date : January 26, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arm Intervention/treatment
Experimental: Autologous HCT-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days

Placebo Comparator: Autologous HCT-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

Experimental: Allogeneic HCT-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days

Placebo Comparator: Allogeneic HCT-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

Experimental: STM-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days

Placebo Comparator: STM-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

Experimental: HM-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days

Placebo Comparator: HM-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

Experimental: HIV-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days

Placebo Comparator: HIV-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Biological: Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days




Primary Outcome Measures :
  1. Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) [ Time Frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118) ]
    Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

  2. Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay [ Time Frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118) ]
    Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

  3. Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) [ Time Frame: up to 28 days post vaccination 4 (up to ~Day 118) ]
    An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized.


Secondary Outcome Measures :
  1. Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) [ Time Frame: Up to Day 5 post any vaccination ]
    An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized.

  2. Percentage of Participants With a Systemic Adverse Event Prompted on the VRC [ Time Frame: Up to 28 days post vaccination 4 (up to ~118 days) ]
    An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized.

  3. Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC [ Time Frame: Up to 28 days post any vaccination (up to ~118 days) ]
    Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized.



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

Inclusion Criteria:

  • Men and women > or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
  • HIV-infected participants with a baseline CD4 cell count < or = to 200 cells/mm^3
  • Participants with hematologic malignancies; or participants who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies

Exclusion Criteria:

  • History of allergy to any vaccine component
  • Prior history of HZ
  • Prior history of receipt of any varicella or zoster vaccine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535236


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00535236    
Other Study ID Numbers: V212-002
2007_608 ( Other Identifier: Merck )
V212-002 ( Other Identifier: Merck )
First Posted: September 26, 2007    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Keywords provided by Merck Sharp & Dohme Corp.:
Prevention of herpes zoster and HZ-related complications
Additional relevant MeSH terms:
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Herpes Zoster
Chickenpox
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs