Human Papillomavirus Vaccination and Screening in the Elimination of HPV-Associated Cancers: Evidence-Based Randomized Trials

Safety, Immunogenicity and Efficacy of Human Papillomavirus Vaccines

Author(s): Matti Lehtinen *

Pp: 18-28 (11)

DOI: 10.2174/9789815305487124010004

* (Excluding Mailing and Handling)

Abstract

Seizing the day is pivotal in vaccination licensure studies, especially when the new vaccine is supposed to protect against a chronic infection with long lead time between the preventable infection and diagnosis of the to-be prevented chronic disease. With appropriate population-based design, that relied on the unique Finnish personal identification number comprehensive health register follow-up was feasible for the definition of safety, immunogenicity and efficacy of both the bivalent and quadrivalent human papillomavirus (HPV) vaccines soon after their licensure. In essentially HPV vaccination naïve population head-to-head comparison of the two vaccines was also feasible. Respectively, in 2002 and 2004 enrolled 1,749 and 4,809 adolescent girls around the ages of 16-17 years were respectively participated in two phase III licensure trials (FUTURE II and PATRICIA) of the quadrivalent and bivalent HPV vaccines. At the same time in 2003 and 2005, 15,615 adolescent, 18-19 year old girls from adjacent birth cohorts were enrolled into a concomitant control cohort. Linkage of the HPV vaccinees cohort with the population-based Finnish Maternity Cohort Serum Bank enabled comparative head-to-head studies on the quadrivalent and bivalent vaccineinduced total and neutralizing antibody responses, which were proven to be equally sustainable up to 12 years post-vaccination, however, with a logarithmic difference in the antibody levels. Linkage of the HPV vaccinees cohort and the concomitant control cohorts with the country-wide Finnish Cancer Registry has enabled the definition of vaccine efficacy (VE) against invasive cervical cancer and cervical intraepithelial neoplasia grade 3 (CIN3+) during 18 years of follow-up with comparable intention-totreat VEs of 68.4% and 64.5%. Linkage with the Hostital Discharge Registry has provided a sentinel, most notably for new onset autoimmune diseases (NOADs) that proved to be more than twice as sensitive as reporting of serious adverse effects but as such did not identify any NOAD-incidence differences between the HPV and control vaccines or unvaccinated population.


Keywords: Efficacy, End-point, Enrolment, Follow-up, Health registry, Immunogenicity, Population-based study, Randomization, Safety, Vaccine efficacy.

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