The researchers involved in this new study are interested in whether giving a HPV vaccine to women at the same time as conisation can lead to a greater rate of HPV clearance compared to conisation on its own, and a result reduce the occurrence of further infection and high grade CIN. The study will do this by using a specific HPV vaccine called Gardasil 9™ which protects against 9 types of HPV infection (types 6, 11, 16, 18, 31, 33, 45, 52 and 58).
Who can participate
Age range18 Years – 55 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female (18-55y) attending for local treatment for presumed CIN2 (cytological and colposcopy impression) OR presumed CIN3 (cytological and colposcopy impression) OR presumed cGIN/AIS (cytological and colposcopy impression) OR biopsy-confirmed CIN2 OR biopsy-confirmed CIN3 OR biopsy-confirmed CGIN/AIS
✓. Written informed consent obtained from the subject prior to enrolment
✓. Free of other relevant health problems as established by medical history and clinical examination, e.g. immunosuppression
✓. Patients who the investigator believes can and will comply with the protocol requirements (e.g. attendance at clinic appointments and return for follow-up visits)
Exclusion criteria
✕. Use of other investigational/non-registered product within 30 days preceding the 1st vaccine dose
✕. Continuous administration of immunosuppressants
✕. Previous vaccination against HPV
✕. Cancer or autoimmune disease under treatment. Patients who have a history of cancer or autoimmune disease but are not currently being treated for the condition will be included
✕. Any confirmed or suspected immunosuppressive condition, including HIV infection
✕. History of allergic disease or any neurologic disorders likely to interact with study vaccination
✕. Acute febrile disease at enrolment (will be postponed)
What they're measuring
1
Incidence of HPV infection in women with high grade cervical intra-epithelial neoplasia after vaccine Gardasil 9™ assess by laboratory test
✕. Pregnant women or women intending to get pregnant during the next 6 months (if pregnant during follow-up, remaining doses will be delayed until after delivery)