Safety and efficacy of live attenuated varicella vaccine for preventing varicella zoster virus disease after allogeneic hematopoietic stem cell transplantation: A Prospective Single-Center Study

UMIN ID: UMIN000013799

Registered date:24/04/2014

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Zoster
• Date of first enrollment: 2014/04/25
• Target sample size: 31
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Live attenuated varicella vaccine (0.5ml SC.) is administered once to allogeneic HSCT patients without active chronic GVHD or ongoing immunosuppressive therapy at 24 months after HSCT. We recommend continuing acyclovir at 200 mg/day until live attenuated varicella vaccine is administered, but the patients who already discontinued acyclovir are permitted to enroll in this study, if they want to do. We propose to measure VZV IgG and VZV specific CTL after 2 weeks, 1 month, 3 months, 6 months, and 1 year.

Outcome(s)

• Primary Outcome: Cumulative incidence of VZV disease
• Secondary Outcome: 1)Adverse effect of vaccine 2)VZV antibody titer before and after vaccination 3)VZV specific CTL before and after vaccinations 4)Factors influencing VZV antibody titer and VZV specific CTL

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients who have a serious active infection 2) Patients who have a high fever above 37.5 degrees when they receive vaccination 3) Patients who have severe acute illness 4) Patients who experienced an anaphylactic shock due to vaccinations 5) Patients who are or may be pregnant 6) Patients with serious mental disorder 7) Patients who developed VZV disease after allogeneic HSCT 8) Patients with VZV-seronegative before allogeneic HSCT 9) Patients who received inactivated vaccine within 1 week or other live attenuated vaccine within 4 weeks 10) Patients who received transfusions or gamma globulin

Related Information

• Primary Sponsor: Division of Hematology, Saitama Medical Center, Jichi Medical University
• Source(s) of Monetary Support: Div. Hematol, Saitama Medical Center, Jichi Medical Univ.