A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy

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, and has not/will not be treated with rituximab in the time period from 3 months prior to enrolment through 28 days following the last dose of study vaccine;
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 reciving 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, and has not/will not be treated with rituximab in the time period from 3 months prior to enrolment through 28 days following the last dose of study vaccine;
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 has been treated with rituximab or is expected to be treated with rituximab in the period from 3 months prior to enrolment through 28 days following the last dose of study vaccine and is likely to receive long-term antiviral prophylaxis (greater than 4 weeks duration) with activity against varicella-zoster virus, 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:<br>1) the development of V212 in adults with STM<br>2) the development of V212 in adults with HM<br>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<br>4) the development of HZ complications; and<br>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: The primary efficacy analysis will be conducted after at least 226 confirmed HZ cases have been accrued.

Secondary Outcome Measures

Name	Time	Method

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