HPV vaccine after treatment for cervical pre-invasive disease

Phase 1

• Conditions: Cervical intra-epithelial neoplasia; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004662-33-SE
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-15
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1000

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
- Free of other relevant health problems as established by medical history and clinical examination
- 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)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Use of other investigational/ non-registered product within 30 days prior to the 1st vaccine dose
- Continuous administration of immunosuppressants
- Previous vaccination against HPV with Gardasil™ or Cervarix™
- Cancer or autoimmune disease under treatment
- 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)
- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified