Review Article

Next Generation Cancer Protection: The Bivalent HPV Vaccine for Females

Table 3

Significant efficacies for Cervarix by endpoint, population and time of follow-up.

EndpointPopulationVaccine efficacy (96.1% CI)Average time of follow-upReference

6 mo persistent infection caused by HPV 16/18ATP-E100% (80, 100)7.3 yrs[64]
12 mo persistent infection caused by HPV 16/18ATP-E100% (56, 100)7.3 yrs[64]
CIN 1+ caused by HPV 16/18ATP-E100% (34, 100)7.3 yrs[64]
CIN 2+ caused by HPV 16/18ATP-E100% (51, 100)8.4 yrs[65]
CIN 2+ caused by HPV 16/18ATP-E*98% (88, 100)48 mo[57]
CIN 3+ caused by any HPV typeTVC-N93% (79–99)48 mo[57]

6-month persistent infection is defined as the detection of DNA from the same HPV type in two consecutive cervical cytology samples collected over any 6-month period and 12-month persistence as detection of the same HPV type in all available cytology samples collected over any 12-month period.
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, and who were seronegative to HPV 16 and 18 and DNA-negative for HPV 16/18 at baseline; cases counting starting one day after the third vaccination.
ATP-E* means those in the ATP-E, but HPV type assignment algorithm was used to resolve causation when multiple HPV types were present.
TVC means total vaccinated cohort: women with at least one injection, seropositive or negative, PCR positive or negative for one or more HPV types at baseline, regardless of Pap result; case counting starting first day after first injection.
TVC-N means TVC-naive: women who received one or more vaccine dose with normal cytology, seronegative for HPV 16/18 and DNA negative for 14 oncogenic HPV types at baseline (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68); case counting starting first day after first injection.