- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00535236
A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)
May 17, 2019 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
341
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
0.65 ml V212 Pbo in 4 dose regimen.
Treatment period of 125 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
|
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
|
Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
|
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.
|
up to 28 days post vaccination 4 (up to ~Day 118)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to Day 5 post any vaccination
|
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.
|
Up to 28 days post vaccination 4 (up to ~118 days)
|
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.
|
Up to 28 days post any vaccination (up to ~118 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 2, 2007
Primary Completion (ACTUAL)
January 25, 2010
Study Completion (ACTUAL)
January 26, 2010
Study Registration Dates
First Submitted
September 25, 2007
First Submitted That Met QC Criteria
September 25, 2007
First Posted (ESTIMATE)
September 26, 2007
Study Record Updates
Last Update Posted (ACTUAL)
May 20, 2019
Last Update Submitted That Met QC Criteria
May 17, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V212-002 (OTHER: Merck)
- 2007_608 (OTHER: Merck)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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