Clinical trial NCT00535236: A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Zoster
Herpes Zoster-related Complications
Keywords: Prevention of herpes zoster and HZ-related complications
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)
timeFrame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
measure: Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
timeFrame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
measure: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
timeFrame: up to 28 days post vaccination 4 (up to ~Day 118)
Secondary outcomes:
measure: Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)
timeFrame: Up to Day 5 post any vaccination
measure: Percentage of Participants With a Systemic Adverse Event Prompted on the VRC
timeFrame: Up to 28 days post vaccination 4 (up to ~118 days)
measure: Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC
timeFrame: Up to 28 days post any vaccination (up to ~118 days)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Mullane KM, Winston DJ, Wertheim MS, Betts RF, Poretz DM, Camacho LH, Pergam SA, Mullane MR, Stek JE, Sterling TM, Zhao Y, Manoff SB, Annunziato PW. Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) in immunocompromised adults. J Infect Dis. 2013 Nov 1;208(9):1375-85. doi: 10.1093/infdis/jit344. Epub 2013 Aug 1.