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

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535236
• Other study ID #: V212-002
• Secondary ID: 2007_608V212-002
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2007
• Est. completion date: January 26, 2010

Study information

• Verified date: May 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: January 26, 2010
• Est. primary completion date: January 25, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Herpes Zoster-related Complications

Intervention

Biological:
• V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
• Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)	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)
Primary	Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay	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)
Primary	Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)	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	Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)	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
Secondary	Percentage of Participants With a Systemic Adverse Event Prompted on the VRC	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)
Secondary	Percentage of Participants With Elevated Oral Temperature (=101.0°F (=38.3ºC) Prompted on the VRC	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)