Phase 1
N=341
A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)
Herpes Zoster · Herpes Zoster-related Complications
Bottom Line
View on ClinicalTrials.gov: NCT00535236 ↗Enrolled (actual)
341
Serious AEs
25.6%
Results posted
Apr 2019
Primary outcome: Primary: Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) — 2.35; 1.28; 1.37 Ratio — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- V212 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) |
2.35; 1.28; 1.37 | <0.001 sig |
| 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 |
3.00; 2.23; 1.76 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) |
32.5; 20.0; 80.0; 70.0; 12.3; 10.5 | — |
| SECONDARY Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) |
10.0; 10.0; 10.0; 0.0; 36.8; 5.3 | >0.999 |
| SECONDARY Percentage of Participants With a Systemic Adverse Event Prompted on the VRC |
5.0; 10.0; 2.5; 0.0; 3.5; 0.0 | 0.556 |
| SECONDARY Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC |
60.5; 50.0; 66.7; 60.0; 7.5; 0.0 | 0.552 |
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
Data sourced from ClinicalTrials.gov (NCT00535236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.