HPV16 E7 DNA tattooing: safety, immunogenicity, and clinical response in patients with HPV-positive vulvar intraepithelial neoplasia.

ABSTRACT:

Background

Usual type vulvar intraepithelial neoplasia (uVIN) is caused by HPV, predominantly type 16. Several forms of HPV immunotherapy have been studied, however, clinical results could be improved. A novel intradermal administration route, termed DNA tattooing, is superior in animal models, and was tested for the first time in humans with a HPV16 E7 DNA vaccine (TTFC-E7SH).

Methods

The trial was designed to test safety, immunogenicity, and clinical response of TTFC-E7SH in twelve HPV16⁺ uVIN patients. Patients received six vaccinations via DNA tattooing. The first six patients received 0.2 mg TTFC-E7SH and the next six 2 mg TTFC-E7SH. Vaccine-specific T-cell immunity was evaluated by IFNγ-ELISPOT and multiparametric flow cytometry.

Results

Only grade I-

SUBMITTER: Samuels S 

PROVIDER: S-EPMC11028457 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature