V212 in Recipients of Autologous Hematopoietic Cell Transplants (001)

• Research type

  Research Study

• Full title

  A Phase III, Double-Blind, Randomised, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Haematopoietic Cell Transplants (HCTs)

• IRAS ID

  56628

• Contact name

  Paul Robinson

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

• Eudract number

  2010-020150-34

• ISRCTN Number

  N/A

• Research summary

  Individuals who have had a primary varicella zoster virus (VZV) infection (chickenpox) are at risk of developing herpes zoster (commonly known as shingles) when cell-mediated immunity decreases. Patients who have weakened immune systems (immunocompromised) such as patients receiving bone marrow or peripheral blood stem cell transplants known as haemopoetic cell transplants (HCTs) have a substantially higher incidence of Herpes Zoster and are at increased risk for developing severe and life-threatening complications compared with the general population.Zostavax is a live attenuated (weakened) varicella zoster virus (VZV) vaccine for the prevention of shingles, however it is contraindicated in patients who are immunocompromised. This study will look at an inactivated form of the VZV vaccine in patients who are receiving an autologous HCT. Autologous HCT means that the stem cells are derived from the patients own bone marrow or peripheral blood.World-wide approximately 1200 patients will be recruited into the study and patients will be randomised to receive either inactivated varicella zoster virus (VZV) vaccine or placebo in a 1:1 ratio. Patients will receive a total of 4 doses of inactivated VZV vaccine/placebo.Patients will continue to be followed in the study until 269 confirmed cases of herpes zoster have occurred and all study patients have completed a 1 year follow-up post last vaccination dose. The study is being funded by the pharmaceutical company who is developing the inactivated VZV vaccine.It is anticipated that 2 UK sites will participate in the study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/68

• Date of REC Opinion

  18 Oct 2010

• REC opinion

  Further Information Favourable Opinion