RCT of immune response in UK adolescent girls to HPV vaccines

• Research type

  Research Study

• Full title

  A Phase IV, randomised study to evaluate the immune responses of UK adolescent girls receiving Cervarix(TM) or Gardasil(TM) Human Papillomavirus vaccines

• IRAS ID

  5907

• Contact name

  Elizabeth Miller

• Sponsor organisation

  Health Protection Agency

• Eudract number

  2008-006773-32

• ISRCTN Number

  Not submitted

• Research summary

  Human papillomavirus (HPV) infection can lead to cervical cancer. There are many types of HPV, including around 12 types that can cause cervical cancer, often called high-risk types (HR-HPV). HPV vaccines (Cervarix and Gardasil) have been developed against two HPV types (HPV16 and HPV18) which together cause around 70% of cervical cancers. One vaccine (Gardasil) also protects against HPV6 and HPV11 which are not associated with cervical cancer but can cause genital warts. Many of the HR-HPV types not included in the vaccines are closely related to either HPV16 or HPV18. For example, HPV 31 and HPV 33 are related to HPV16 and HPV 45 is closely related to HPV 18; together these types cause around 12% of cervical cancers. Vaccines against HPV16 and HPV18 may offer some protection against related HR-HPV types.We propose to randomly allocate adolescent girls to be immunised with Cervarix or Gardasil, at months 0, 1 and 6. Four blood samples will be collected and participants will be asked for a voluntary self-taken lower vaginal sponge sample at month 7. Using these blood and vaginal samples, we will look to see whether the immune response after HPV vaccination can react against HPV types that are not included in the vaccines. We will also look at whether Cervarix and Gardasil are different in terms of their cross-reactivity. This information may help predict what will happen to each HR-HPV type when the population is vaccinated against HPV16 and HPV18 and may also help guide future vaccine development.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/25

• Date of REC Opinion

  19 Mar 2009

• REC opinion

  Further Information Favourable Opinion