The following is a summary of “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 ” published in the November 2022 issue of Clinical Cancer by Hillemanns et al.

Using a novel modular vaccination technique based on attaching antigens to a CCL3L1 targeting module, researchers will test the safety, immunogenicity, and efficacy of a therapeutic Deoxyribonucleic acid(DNA) vaccine, VB10.16 in women with HPV16-positive high-grade cervical intraepithelial neoplasia (CIN). Researchers evaluated VB10.16 in phase I/IIa open-label study in patients with HPV16-positive CIN 2/3. Rates of adverse events, including dose-limiting toxicities, were the key measure of success. In addition, E6/E7-specific cellular immune response was measured as a secondary endpoint. 

HPV16 clearance, regression of CIN lesion size, and regression of CIN grade were evaluated over a 12-month follow-up in the Expansion cohort. Researchers enrolled a total of 34 females (18 in the expansion cohort and 16 in each of 2 dosage cohorts). In addition, no participants discontinued treatment with VB10.16 because of adverse events, and no significant adverse events or dose-limiting toxicities were identified. Most reported adverse events (79%) were classified as mild to moderate injection site responses. 

After vaccination, most people showed signs of having HPV16-specific T-cell responses. About 8  of 17 (47.3%) evaluable participants in the expansion cohort achieved HPV16 clearance.  About 10 patients (59%) regressed to CIN 0/1, and 16 (94%) saw a reduction in lesion size. There was a statistically significant (P<0.001) correlation between high levels of IFN T-cell responses and diminished lesion size. Positive effectiveness data and robust HPV16-specific T-cell responses were observed in participants with high-grade CIN after vaccination with the new therapeutic DNA vaccine VB10.

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