Janice Brown
A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The proposed indication for the investigational heat-treated varicella-zoster virus (VZV) vaccine is the prevention of herpes zoster (HZ) and HZ-related complications in immunocompromised individuals.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Vaccine: V212
- Vaccine: Comparator: Placebo (unspecified)
Phase:
Phase 1Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Men and women 18 years of age or older
- Patients who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
- HIV-infected patients with a baseline CD4 cell count < or = to 200 cells/mm^3
- Patients with hematologic malignancies
- Patients who are receiving chemotherapy for breast, colorectal, or lung malignancies
Key Exclusion Criteria:
- History of allergy to any vaccine component
- Prior history of herpes zoster
- Prior history of receipt of any varicella or zoster vaccine
Additional Study Details
Official Title:
A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised AdultsAnticipated start date:
10/29/2008Lead Sponsor:
MerckInvestigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
SafetyPrimary Outcomes:
- Immunogenicity of V212 when administered to immunocompromised patients.
Secondary Outcomes:
- Safety and tolerability of V212 in immunocompromised patients.
Total Number to be Enrolled:
340Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- BMT194
- NCT00535236
- V212-002
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/4/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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