We describe the final 10-year data for the long-term follow-up study of the 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents.
In the base study (V501-018), 1661 sexually inactive boys and girls received the 4vHPV vaccine (early vaccination group [EVG], managed for 9.9 years) or a placebo at day 1, month 2, and month 6. Thereafter, at month 30, the placebo group (catch-up vaccination group [CVG], managed for 7.4 years) received the 4vHPV vaccine by using the same dosing schedule. Long-term anti-HPV type 6, 11, 16, and 18 immune responses were assessed. Effectiveness was estimated by calculating the incidence rate of the primary endpoints (HPV types 6, 11, 16, and 18–related disease or persistent infection).
For HPV types 6, 11, and 16, 89% to 96% of subjects remained seropositive through 10-years postvaccination. The preadolescents had 38% to 65% higher geometric mean titers at month 7, which remained 16% to 42% higher at 10 years compared with adolescents. No cases of HPV type 6, 11, 16, and 18–related diseases were observed. Ten subjects had a persistent infection of ≥6 months duration with vaccine-type HPV and 2 subjects had persistent infection for ≥12 months. No new serious adverse events were reported through 10 years.
A 3-dose regimen of the 4vHPV vaccine was immunogenic, clinically effective, and generally well tolerated in preadolescents and adolescents during 10 years of follow-up. These long-term findings support efforts to vaccinate this population against HPV before exposure.
Comments
Controvercial conclusions used to promote early HPV recommendations.
The authors note that they were unable to adequately assess the efficacy of the 4vHPV vaccine in the long-term prevention of cancer,due to the omission of a placebo control group from the study design. The critical questions as to the minimum necessary levels of protective antibodies required for adequate inoculation, current recommendations, cost and side effects were not addressed in the article. Individualizing the decision to subject the child to an HPV vaccine and delay of requirement for routine HPV immunization from age 11 to before 15th birthday is the best course of action.
Doctors should be able to make a clinical call about vaccination based on Tanner maturity staging, dating or sex initiation expectations and religious beliefs, without fear of financial and other repercussions
Dr, Lia Arber
The authors conclude that there is evidence supporting vaccination prior to exposure to HPV. However, fundamental flaws in this research call these conclusions into question. The authors note that they were unable to adequately assess the efficacy of the 4vHPV vaccine due to the omission of a placebo control group from the study design.Many Pediatricians feel that revision of CDC recommendations, and delay of NCQA requirements, for routine HPV immunization from age 11 to before one's 15th birthday, will benefit compliance and long-term protection against HPV infection.Individualizing the decision to subject a child to the HPV vaccine, in collaboration with parents, is the best course of action given the paucity of data on long-term outcomes, future consequences, and side effects.