Heat-Treated Varicella Zoster Vaccine Clinical Trial

TITLE:
Evaluate the Safety and Immunogenicity of V212/Heat-treated Varicella Zoster Virus Vaccine in Immunocompromised Adults

PURPOSE:
Prevention of herpes zoster disease in immunocompromised patients, including hematopoietic cell transplant, HIV infected patients with moderate-to-severe immunodeficiency, patients with hematologic malignancy, and patients with solid tumor malignancy receiving chemotherapy who represent an significant medical need since these immunocompromised patients cannot receive the live attenuated zoster vaccine.

This study will expand upon the experience of the earlier studies in hematologic malignancy recipients and provide information on the safety and immunodeficiency of 4 doses of the heat-treated varicella zoster vaccine in a broad population of immunocompromised patients.

The immunocompromised population is heterogeneous .Data from the study will be the basis for decisions regarding future clinical studies in these patient populations.

PHASE:
1

INSTITUTIONAL REVIEW BOARD:
Western Institutional Review Board

STATUS:
Closed

ELIGIBILITY:
Adults aged 18 years and older with a history of varicella, those with antibodies to varicella zoster virus who are immunocompromised as a result of  HIV, those who have had a hematopoietic cell transplant, those who have hematologic malignancy, and those with solid tumor malignancy who are receiving chemotherapy.

DURATION:
6 visits over 9 months

Prinicpal Investigator:
Michael Wax, MD

CONTACT:
Kelly Ritter, CCRC
908-277-8747