Trial to Study the Safety and Effectiveness of V212 Vaccine in Adult Patients with Solid Tumor or Blood Cancers

Phase 1

• Conditions: Herpes Zoster; MedDRA version: 18.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-023156-89-BG
• Lead Sponsor: Merck Sharp & Dohme Corp.a subsidiary of Merck & Co., Inc., USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-04
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5136

Inclusion Criteria

Patient is =18 years of age with a solid tumor or hematologic malignancy receiving immunosuppressive or cytotoxic chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.

Patient is =50 years of age with a hematologic malignancy not in remission, may or may not be receiving chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years, is not likely to undergo hematopoietic cell transplant is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient has a prior history of HZ within 1-year of enrolment, a prior history of receipt of any varicella or zoster vaccine, is likely to undergo hematopoietic cell transplant and is likely to receive long term antiviral prophylaxis (greater than 4 weeks duration) with activity against varicella-zoster virus zoster, cytomegalovirus, or herpes simplex virus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of V212 (inactivated VZV vaccine) in adults with solid tumor or hematologic malignancy and to assess the impact of inactivated VZV vaccine on the development of HZ in adults with solid tumor or hematologic malignancy;Secondary Objective: To assess the impact of inactivated VZV vaccine on: 1) the development of V212 in adults with STM; 2) the development of V212 in adults with HM; 3)the development of moderate to severe HZ-associated pain at any time from HZ onset through the end of the 6 month HZ follow-up period; 4) the development of HZ complications, and 5) the development of PHN.;Primary end point(s): The primary clinical efficacy endpoint is the incidence of herpes zoster.;Timepoint(s) of evaluation of this end point: First interim analysis approximately 3 years after enrollment begins; second interim analysis approximately 4 years after enrollment begins; final analysis approximately 5 years after enrollment begins.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Vaccination with V212 will reduce the incidence of HZ compared with placebo in adults with STM.<br><br>Vaccination with V212 will reduce the incidence of HZ compared with placebo in adults with HM.<br>;Timepoint(s) of evaluation of this end point: First interim analysis approximately 3 years after enrollment begins; second interim analysis approximately 4 years after enrollment begins; final analysis approximately 5 years after enrollment begins.