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Completed

NCT Number: NCT00535236

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

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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpes Zoster-related Complications Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V212

Biological

0.65 ml V212 in 4 dose regimen. Treatment period of 125 days

Placebo

Biological

0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2007
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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