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Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia
Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia

NCT03979014

CompletedPhase 3

Sponsor: Imperial College London

Conditions: Neoplasia

Interventions: Gardasill 9™ vaccine

Countries: Finland, Sweden, United Kingdom

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).

Eligibility overview

Sex: FEMALE

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria

Patients who meet all of the following inclusion criteria will be considered eligible for this study:

1. 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
2. Written informed consent obtained from the subject prior to enrolment
3. Free of other relevant health problems as established by medical history and clinical examination, e.g. immunosuppression
4. 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

Patients who meet any of the following exclusion criteria will not be eligible for this study:

1. Use of other investigational/non-registered product within 30 days preceding the 1st vaccine dose
2. Continuous administration of immunosuppressants
3. Previous vaccination against HPV
4. 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
5. Any confirmed or suspected immunosuppressive condition, including HIV infection
6. History of allergic disease or any neurologic disorders likely to interact with study vaccination
7. Acute febrile disease at enrolment (will be postponed)
8. 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)
Locations (13)
  • Helsinki, Finland
  • Tampere, Finland
  • Gothenburg, Sweden
  • Gothenburg, Sweden
  • Västra Frölunda, Sweden
  • Leeds, England, United Kingdom
  • London, England, United Kingdom
  • London, England, United Kingdom
  • Manchester, England, United Kingdom
  • Middlesex, England, United Kingdom
  • Nottingham, England, United Kingdom
  • Fulwood, Preston, United Kingdom
  • London, United Kingdom