CompletedPhase 1/2

An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3)

Germany34 participantsStarted 2015-08

Plain-language summary

This is an exploratory, open, prospective multi-centre study of VB10.16 immunotherapy in patients with high grade HPV16+ Cervical Intraepithelial Neoplasia (HSIL; CIN2/3). This study will recruit approximately 27-40 female patients with high grade cervical intraepithelial neoplasia (HSIL, CIN 2/3) at multiple sites in Europe.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Women ≥18 years
✓. Women with ectocervical HPV16+ associated High Grade Cervical Intraepithelial Neoplasia (HSIL) as verified by local pathology:
✓. Satisfactory colposcopic examination.

Exclusion criteria

✕. More than 2 cervical quadrants of CIN 3 as visualised by colposcopy.
✕. Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease.
✕. Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination.
✕. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
✕. Administration of any blood product within 3 months of enrolment.
✕. Concomitant or prior malignant disease.
✕. Clinically significant autoimmune disease.
✕. Known allergy to Kanamycin or other aminoglycosides

What they're measuring

Safety/tolerability

Timeframe: 6 months (extended follow up for additional 6 months)

Trial details

NCT IDNCT02529930

SponsorNykode Therapeutics ASA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-31

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