ProCervix vs placebo in women with HPV 16 & HPV 18 infection
Research type
Research Study
Full title
A double-blind, randomised, placebo-controlled, Phase II study to evaluate ProCervix efficacy to clear HPV 16 and HPV 18 infection in women with normal cytology or ASCUS/LSIL
IRAS ID
139521
Contact name
Emma Crosbie
Contact email
Sponsor organisation
Genticel
Eudract number
2013-003358-25
Clinicaltrials.gov Identifier
Research summary
Cervical cancer is the third most common malignancy among women worldwide. Despite a 50% decline in the mortality rate in developed countries, cervical cancer remains an important public health problem accounting for 24,400 deaths throughout Europe in 2012.
HPV (human papillomavirus) types 16 and 18 cause about 70% of all cervical cancers. HPV is the most common sexually transmitted infection and when the infection persists (in 5- 10% of infected women) there is high risk of developing precancerous lesions of the cervix, which can progress to invasive cervical cancer. Progression can be prevented, but the lesions still cause considerable burden necessitating preventive surgeries, sometimes resulting in the loss of fertility. There is currently no known treatment for HPV infections.
Genticel has developed a therapeutic vaccine called ProCervix to clear HPV 16 and 18 genital infections and therefore to prevent the development of cervical pre-cancerous lesions. A therapeutic vaccine differs from a preventive vaccine by its ability to fight an infectious or malignant disease already established.
This double blind placebo controlled study will investigate the effectiveness and safety of ProCervix in women who are at risk of developing precancerous lesions of the cervix due to HPV 16 and/or HPV 18 infection. ProCervix has been tested previously in 53 women; the results so far indicate that it is effective and has an acceptable safety profile.
After a 4 week screening period, participants will be randomly assigned to receive 2 intradermal injections of either ProCervix or placebo. There will be a 6 week interval between the injections. Participants will be followed up for 2 years. Study assessments include gynaecological examinations, cervical smears, physical examinations and blood tests.
222 patients will take part from 8 countries in Europe.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0778
Date of REC Opinion
8 Jan 2014
REC opinion
Further Information Favourable Opinion