HPV vaccinee follow up from previous studyEUDRACT study 2008-006773-32
Research type
Research Study
Full title
An observational follow up study of a randomised parallel group phase IV study to evaluate the duration of the immune response to vaccine and non-vaccine HPV types in UK adolescent females who received either Cervarix or Gardasil Human Papillomavirus (HPV) vaccines.
IRAS ID
207732
Contact name
Paul Turner
Contact email
Sponsor organisation
Public Health England
Eudract number
2016-002083-13
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
HPV vaccines have been included in the national immunisation schedule since 2008, firstly as the Cervarix vaccine which protects against two HPV types and in 2012 as the Gardasil vaccine which offers protection against a further two HPV types. This study will assess whether booster doses are indicated to protect females throughout their lifetime or if the vaccinations offered in early adolescence provide this by following up a cohort from a previous study where female adolescents were vaccinated 5-7 years ago.
Our initial randomised controlled trial, EUDRACT number 2008-006773-32, evaluated immune responses to two Human Papilloma Virus (HPV) vaccines licensed for use in the UK, Gardisil and Cervarix. Subjects were randomised to receive one these vaccines in a three dose schedule to assess their immune responses. Antibody decay/decline over time can now be assessed by a single blood test. All 198 original participants will be invited to participate.
The study will be funded by the Department of Health (DH) and carried out by the National Vaccine Evaluation Consortium (NVEC). Information from the study will be provided to the DH Joint Committee for Vaccination and Immunisation (JCVI) which advises on the national immunisation schedule.
We hope to see participants in a short timeframe, but given they may now attend university away from home this may need to incorporate holiday periods when they return. We have allowed 6-12 months to complete all study visits, but hope to achieve this more quickly.
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1108
Date of REC Opinion
21 Jul 2016
REC opinion
Favourable Opinion