Safety and Immunogenicity of a Human Papillomavirus Peptide Vaccine (CIGB-228) in Women with High-Grade Cervical Intraepithelial Neoplasia: First-in-Human, Proof-of-Concept Trial

Table 1

Results of detection of HPV16 correlated with clinical and immune response.

Patients	Age	HPV 16 before vaccine	HPV 16 prior to LEEP	Initial histology	End histology after LEEP	Clinical status	Immune response
01	43	+	+	CIN II	Koilocytosis	CR	+
02	38	+	+	CIN III	CIN III	SD	+
03	24	+	+	CIN III	CIN II	PR	+
04	25	+	−	CIN II	Koilocytosis	CR	+
05	26	+	−	CIN III	Koilocytosis	CR	+
06	25	+	−	CIN III	Negative	CR	+
07	25	+	+	CIN III	CIN III	SD	+

Note: All patients were positive for HLA-A2.
Initial histology was by cervical biopsy prior to the study. End histology was by LEEP at termination of the study (90 days after the first vaccine administration).
Abbreviations
CIN II-III: cervical intraepithelial neoplasia, grade II or III.
CR: complete response; PR: partial response; SD: stable disease.