Next Generation Cancer Protection: The Bivalent HPV Vaccine for Females

Table 6

Vaccine efficacy in women 15–25 years old who were DNA-negative for HPV 16 or 18 at baseline [67].

Endpoint	Population	Serostatus	Vaccine efficacy (96.1% CI)	Average time of follow-up
6-month persistent infection caused by HPV 16/18	ATP-E	Seropositive	81% (59, 92)	41 month
12-month persistent infection caused by HPV 16/18	ATP-E	Seropositive	92% (64, 99)	41 month
CIN 2+ caused by HPV 16/18	ATP-E*	Seropositive or seronegative	99% (90, 100)	41 month

Infection definitions: 6-month definition required the detection of the same HPV type in two consecutive cervical samples, with no negative sample in between, over a minimum of 5 months; a 12-month definition required the detection of the same HPV type at consecutive assessments, with no negative samples in between, over a minimum of 10 months.
ATP-E means according to protocol for efficacy all women who met eligibility criteria and complied with the protocol, who received three injections; whose baseline Pap was normal, ASCUS, or LSIL cases counting starting day after the third vaccination.
ATP-E* means those subjects that are HPV-DNA-negative for HPV 16/18 at study entry regardless of initial serostatus with the HPV type assignment algorithm aand used to resolve causation when multiple HPV types were present. 14% of women were seropositive for HPV 16, and 10% were seropositive for HPV 18 at study entry; all were HPV-DNA-negative for HPV 16/18.