Phase 3
Completed N=1,230
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)
Source: ClinicalTrials.gov NCT01229267 ↗Enrolled (actual)
1,230
Serious AEs
65.6%
Results posted
Jul 2018
Primary outcomePrimary: Incidence of Confirmed Herpes-Zoster — 32.889; 91.883 Number of cases per 1000 person years
◆ Published Evidence
Established
96citations · ~12 / year
Inactivated varicella zoster vaccine in autologous haemopoietic stem-cell transplant recipients: an international, multicentre, randomised, double-blind, placebo-controlled trial.
Summary
This is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of autologous hematopoietic cell transplants (HCTs). The primary hypothesis is that vaccination with V212 vaccine will reduce the incidence of herpes zoster (HZ) compared to placebo when administered to recipients of HCT. The statistical criterion for success requires that the lower bound of the 95% confidence interval for the estimated vaccine efficacy in the V212 recipients (excluding the high-antigen lot) compared with that in the placebo recipients is >25%.
Linked Publications (3)
-
Inactivated varicella zoster vaccine in autologous haemopoietic stem-cell transplant recipients: an international, multicentre, randomised, double-blind, placebo-controlled trial.
-
Immunogenicity of Inactivated Varicella Zoster Vaccine in Autologous Hematopoietic Stem Cell Transplant Recipients and Patients With Solid or Hematologic Cancer.
-
Cost and utility in immunocompromised subjects who developed herpes zoster during the randomized V212 inactivated varicella-zoster vaccine (ZV<sub>IN</sub>) trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Confirmed Herpes-Zoster |
32.889; 91.883 | — |
| PRIMARY Percentage of Participants With One or More Serious Adverse Events |
32.9; 32.7 | 0.942 |
| SECONDARY Incidence of Moderate to Severe Herpes-Zoster-Associated Pain |
14.878; 49.601 | — |
| SECONDARY Incidence of Herpes-Zoster Complications |
9.397; 35.777 | — |
| SECONDARY Incidence of Postherpetic Neuralgia |
2.349; 14.636 | — |
Eligibility Criteria
Inclusion Criteria
- Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for ≥30 years or if participant is 6 months (>180 days) of prophylactic antiviral therapy post-HCT.
- Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 6 months from last vaccination dose.
- Has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4.
- Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Doses 1 through 4.
Data sourced from ClinicalTrials.gov (NCT01229267) and the linked publication. 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. Informational only — not medical advice.