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

Phase 1/2 Completed 34 enrolled Nykode Therapeutics ASA Theradex · collab Vaccibody AS · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2015-08
Primary completion: 2019-01-31
Completion: 2019-01-31

Publications

Hillemanns P, Denecke A, Woelber L, Bohmer G, Jentschke M, Schjetne KW, Bruins Slot KMH, Fredriksen AB. A Therapeutic Antigen-Presenting Cell-Targeting DNA Vaccine VB10.16 in HPV16-Positive High-Grade Cervical Intraepithelial Neoplasia: Results from a Phase I/IIa Trial. Clin Cancer Res. 2022 Nov 14;28(22):4885-4892. doi: 10.1158/1078-0432.CCR-22-1927.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABIPAPOGENE SUVAPLASMID	Vaccine	3 mg	Intramuscular

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

Summary

Timeline

Publications

Drugs

Indications