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-FI
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-16
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

- Female 18-55 years old, attending hospital for localised cervical treatment for biopsy confirmed cervical intra-epithelial neoplasia (CIN) 2/3
- Written informed consent
- Free of other relevant health problems as established by medical history and clinical examination
- Able to comply with protocol including completion of diary cards, follow up etc
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

- Women treated for cervical glandular intra-epithelial neoplasia (cGIN) / adenocarcinoma in situ (AIS)
- Use of other investigational/ non-registered product within 30 days prior to the 1st vaccine dose
- Continuous administration of immunosuppressants prior to the 1st vaccine dose
- 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 (oral > 37.5°C / axillary temperature > 37.5°C) (will be postponed)
- Pregnant women or women intending to get pregnant in the next year (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