Uterine Cervical Cancer Clinical Trial
Official title:
A Long-term Follow-up Registry-based Cohort Study of HPV Vaccine Efficacy Against Cervical Pre-cancerous Lesions and Cervical Cancers in a Cohort of Females Previously Enrolled From Finland in Study HPV-008, as Compared to a Non-intervention Population -Based Reference Cohort of Females From Finland
Summary
For ethical and practical reasons pre-licensure clinical efficacy phase III trials for GSK
Biologicals' HPV-16/18 LI VLP AS04 vaccine used cervical intraepithelial grade 2 and above
(CIN2+) lesions as surrogate efficacy endpoint for cervical cancer. The long-term impact of
HPV vaccination on cervical cancer as well as other HPV-related non- cervical cancers is,
however, an area warranting further exploration in the post-licensure setting. Results of
the multinational phase III trial demonstrated high vaccine efficacy against CIN2+
associated with HPV-16 and/or HPV-18, significant vaccine efficacy against CIN2+ and CIN3+
irrespective of HPV type in the lesion as well as evidence of protection against CIN2+
associated with HPV types 31 and 45 [Paavonen, et al. 2009]. Over time, vaccinated cohorts
should benefit from a substantial reduction in the incidence of cervical cancer considering
impact on oncogenic non-vaccine HPV types. This long-term study is conducted to evaluate the
long-term impact of GSK Biologicals' HPV-16/18 vaccine on the occurrence of cervical
pre-cancerous lesions and cervical cancer with the following objectives:
- To assess the long-term efficacy of the HPV-16/18 L1 VLP AS04 vaccine on the occurrence
of cervical cancer including its immediate precursors (CIN3+): cervical intraepithelial
neoplasia grade 3 (CIN3) and adenocarcinoma in situ (AIS) by comparing cohorts A and C
(see below).
- To assess the efficacy of HPV-16/18 L1 VLP AS04 vaccine on the occurrence of the
following potentially HPV related non-cervical cancers such as vulvar intraepithelial
neoplasia, vaginal intraepithelial neoplasia, anogenital neoplasia and oropharyngeal
neoplasia by comparing cohorts A and C (see below)
- To assess as an explanatory objective the occurrence of CIN3+ breakthrough cases
associated with HPV-16 or HPV-18 infection in subjects vaccinated with HPV-16/18 L1 VLP
AS04 vaccine by close surveillance of cohorts and cross vaccinated cohort B (see below)
This prospective, observational cohort study is undertaken in originally 16-17 year-old
Finnish females who have participated in the GSK Biologicals' HPV-008 trial (NCT00122681)
with regular clinical follow-up, and can be divided in Cohort A: Female subjects from
Finland who received HPV-16/18 L1 VLP AS04 vaccine in the HPV-008 study between May 2004 and
May 2005 (N=2409), and Cohort B: Female subjects from Finland who received the Hepatitis A
control vaccine in the HPV-008 study (N=2399). All subjects were offered the HPV-16/18 L1
VLP AS04 vaccine or screening for cervical cancer at the end of the study (age 21-22): 50%
of the subjects, chose not to take cross-over HPV vaccination at HPV-008 study end. Referent
Cohort C: A population-based reference cohort of female subjects from Finland who have not
been exposed to any HPV vaccine (either during a HPV vaccine trial, or commercially
available vaccine; i.e. Cervarix or Gardasil), enrolled in this study in May - September
2003 or May - September 2005, altogether 15536 subjects).
Prospective data collection will start at the HPV screening invitation for each subject in
2013. Several analyses are planned including an analysis at 8 years post-completion of the
HPV-008 study (by 2020) and will provide a total evaluation time of approximately 15 years
since first vaccination in the Cohort A.
The study is self-contained for the primary and secondary endpoints. Data from the HPV-008
trial will be used to address exploratory objectives mentioned above. Data collection will
be performed using the databases from the University of Tampere.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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