V212-011 Study of Safety & Efficacy of V212 in patients with ST or HTM

• Research type

  Research Study

• Full title

  Protocol V212-011 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

• IRAS ID

  72836

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2010-023156-89

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  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 patients) such as patients with haematologic malignancies or those with solid tumour malignancies who are receiving chemotherapy have a substantially higher incidence of herpes zoster and are at risk of developing severe and life threatening complications compared with the general population.Zostavax is live attenuated (weakened) varicella zoster virus (VZV) vaccine for the prevention of shingles, and is therefore contraindicated in patients who are immunocompromised. This study will look at an inactivated form of the VZV vaccine in patients with solid tumours and haematological malignancies including patients receiving chemotherapy.World wide, approximately 5136 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 vaccine/placebo. Each dose will be given approximately 30 days apart.Patients will continue to be followed in the study until 226 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 1 UK site will participate in the study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0149

• Date of REC Opinion

  13 Jun 2011

• REC opinion

  Further Information Favourable Opinion