phase IIIb, open, multi-centre gynaecological follow-up study

• Research type

  Research Study

• Full title

  A phase IIIb, open, multi centre gynaecological extension study for follow-up of a subset of 580299/008 study subjects who were either cervical cytology negative and oncogenic HPV positive or pregnant at their final 580299/008 study visit (Visit 10 at Month 48)

• IRAS ID

  24242

• Contact name

  Henry C Kitchener

• Eudract number

  2008-008124-33

• ISRCTN Number

  N/A

• Research summary

  HPV008 was a randomised trial of HPV16/18 vaccination with Cervarix amongst women aged 15-26. The primary endpoint was the development of CIN grade 2 or worse. This showed that Cervarix has over 90% efficacy in preventing HPV16/18 related CIN2. The HPV052 study is a four-year gynaecological follow-up for women from HPV008 study who were either pregnant at their final visit (so unable to have a cervical sample taken), or whose cervix was healthy, but tested positive for high-risk human papillomavirus (HPV) infection. The aim is to see whether further CIN2 develops during the extended follow-up of four more years. Both studies are funded by GlaxoSmithKline (GSK).This study will offer these women annual cervical screening for up to four years and treatment if required. Each visit will involve a gynaecological examination and cervical cytology test for high-risk HPV infection and abnormal cells in the cervix. If the tests are abnormal, colposcopic directed biopsies (small piece of tissue the size of a lentil removed from the cervix) may be taken for examination and the woman referred if this is required. Once the results become negative, she will leave the study. If a woman reaches the end of the four-year period and has not developed cervical lesions but still tests positive for high-risk HPV infection, she will be informed of the need for regular cervical screening. On completion of the study all participants will be referred to their local healthcare provider.This study will be conducted in 15 countries, on about 2000 young women (30 in the UK, involving 5 sites). Possible side effects are vaginal spotting after a biopsy (if required). The participants will benefit by having regular gynaecological examinations and tests performed to see if they develop abnormal cells in the cervix that could eventually lead to cervical cancer.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/38

• Date of REC Opinion

  9 Oct 2009

• REC opinion

  Further Information Favourable Opinion