Phase 1
N=80
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013)
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT01460719 ↗Enrolled (actual)
80
Serious AEs
15.0%
Results posted
Mar 2019
Primary outcome: Primary: Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT) — 4.34 Ratio — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- V212 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT) |
4.34 | <0.001 sig |
| PRIMARY Percentage of Participants With an Adverse Event |
85.0 | — |
| PRIMARY Percentage of Participants With an Injection-site Adverse Event |
43.8 | — |
| PRIMARY Percentage of Participants With a Systemic Adverse Event |
73.8 | — |
| PRIMARY Percentage of Participants With a Serious Adverse Event |
15.0 | — |
| PRIMARY Percentage of Participants With a Vaccine-related Serious Adverse Event |
1.3 | — |
| PRIMARY Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event |
1.3 | — |
Summary
An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at ~28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in V212 recipients is >1.0.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with a HM and is receiving treatment with anti-CD20 monoclonal antibodies and is not likely to undergo hematopoietic cell transplant (HCT).
- Has a predicted life expectancy of ≥ 12 months.
- Has prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.
- All female participants of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion Criteria
- A history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.
- Prior history of HZ within 1 year of enrollment.
- Prior receipt of any varicella or zoster vaccine.
- Participant is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
- Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days postvaccination dose 4.
- Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.
- Participant is currently participating or has participated in a study with an investigational anti-CD20 monoclonal antibody within 3 months of signing informed consent.
Data sourced from ClinicalTrials.gov (NCT01460719). 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.