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Uterine Cervical CancerNCT01393470

Evaluation of Long-term HPV Vaccine Efficacy

An observational study of Uterine Cervical Cancer, run by Tampere University at 15 sites in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 19 years, women onlyHealthy volunteers can take part
Conditions the study is for
Uterine Cervical Cancer
What is being tested?
Screening for cervical cancer
Type of treatment
Vaccines, Surgery or procedure
How many people
10,000 participants
Where
15 sitesFinland
Study dates
May 2011to Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 19 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Study population: Trial Cohort (16-17 years at baseline) - the cohort of Finnish subjects who participated in the GSK Biologicals' HPV-008 trial (NCT00122681): Cohort A: subjects who received HPV-16/18 L1 VLP AS04 vaccine between May 2004 and May 2005. Cohort B: subjects who received the Hepatitis A control vaccine. All subjects were offered the HPV-16/18 L1 VLP AS04 vaccine at the end of the study (age 21-22): Cohort B1: subjects who received the Hepatitis A control vaccine and then received cross-over HPV vaccination at HPV-008 study end. Cohort B2: subjects who received the Hepatitis A control vaccine and who did not receive cross-over HPV vaccination at HPV-008 study end. Referent cohort (18-19 years at baseline): Cohort C: A population-based reference cohort of female subjects from Finland who have not been exposed to any HPV vaccine enrolled in this study in May 2005, immediately after recruitment of the HPV-008 clinical trial subjects had been stopped (approximately 9,000 subjects).

Who may be able to join

  • Trial Cohort (16-17 years at baseline) - the cohort of Finnish subjects who participated in the GSK Biologicals' HPV-008 trial (NCT00122681):
  • Cohort A: subjects who received HPV-16/18 L1 VLP AS04 vaccine between May 2004 and May 2005.
  • Cohort B: subjects who received the Hepatitis A control vaccine. All subjects were offered the HPV-16/18 L1 VLP AS04 vaccine at the end of the study (age 21-22).
  • Cohort B1: subjects who received the Hepatitis A control vaccine and then received cross-over HPV vaccination at HPV-008 study end.
  • Cohort B2: subjects who received the Hepatitis A control vaccine and who did not receive cross-over HPV vaccination at HPV-008 study end.
  • Referent cohort (18-19 years at baseline):
  • Cohort C: A population-based reference cohort of female subjects from Finland who have not been exposed to any HPV vaccine enrolled in this study in May 2005, immediately after recruitment of the HPV-008 clinical trial subjects had been stopped (approximately 9,000 subjects).

Who cannot join

  • Trial Cohort (Cohort A and B): Previous or planned administration of an HPV vaccine not foreseen by the HPV-008 study protocol or any HPV-008 extension study protocol (Gardasil or any experimental HPV vaccine).
  • Referent cohort (Cohort C): Previous or planned administration of an HPV vaccine (Cervarix, Gardasil or any experimental HPV vaccine).

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Finland15 sites

  • Väestöliitto Seksuaaliterveysklinikka

    Helsinki, 00101

  • Nuorten rokotetutkimukset

    Jyväskylä, 40100

  • Nuorten rokotetutkimukset

    Kotka, 48100

  • Nuorten rokotetutkimukset

    Kouvola, 45100

  • Nuorten rokotetutkimukset

    Kuopio, 70100

  • Nuorten rokotetutkimukset

    Lahti, 15110

  • Nuorten rokotetutkimukset

    Lappeenranta, 53100

  • Nuorten rokotetutkimukset

    Mikkeli, 50100

  • VL-Medi Oy/Pikkuklinikka

    Oulu, 90220

  • Nuorten rokotetutkimukset

    Pori, 28100

  • Nuorten rokotetutkimukset

    Rauma, 26100

  • Nuorten rokotetutkimukset

    Seinäjoki, 60100

  • Nuorten rokotetutkimukset

    Tampere, 33100

  • Nuorten rokotetutkimukset

    Turku, 20100 Turku

  • Nuorten rokotetutkimukset

    Vaasa, 65100

Other trials in Finland

About this study

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:

Read more
  • 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.

Being tested
Screening for cervical cancer
Keywords
HPV, Vaccine, long-term efficacy, registry-based study, Evaluation of long-term HPV vaccine efficacy: a population-based, registry-based cohort study in Finland.
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Screening for cervical cancerProcedure or surgery

    Organized screening for cervical cancer start for all cohorts at the age of 25 years with 5 year interval.

Study groups in NCT01393470
Study groupRoleWhat they receive
Cohort A (Trial Cohort, Vaccinated during HPV-008)Cohort A subjects were previously enrolled in the HPV-008 study, and have received at least 1 dose of the HPV vaccine. Cohort A subjects have provided written informed consent prior to enrolment to allow retrieval of biospecimens for HPV DNA testing and confirmation of diagnosis. Subjects who provided written informed consent prior to enrolment for the use of their personal identifier for linkage purposes to Finnish Registries.
Receives: Procedure: Screening for cervical cancer
Cohort B1 + B2Cohort B1 subjects were previously enrolled in the HPV-008 study and received at least 1 dose of HPV vaccine as cross-over vaccination at the end of the HPV-008 study. Cohort B1 subjects have provided written informed consent prior to enrolment to allow retrieval of biospecimens for HPV DNA testing and confirmation of diagnosis. Subjects who provided written informed consent prior to enrolment for the use of their personal identifier for linkage purposes to Finnish Registries. Cohort B2 (Trial Cohort, Non-Vaccinated)
Receives: Procedure: Screening for cervical cancer
Cohort C (Referent Cohort, Non-Vaccinated)Cohort C subjects have not participated in the HPV-008 study but have been enrolled in the Referent Cohort. Cohort C subjects have not received any HPV vaccination (neither Cervarix, nor Gardasil, nor any experimental HPV vaccine). Cohort C subjects are partially matched to HPV-008 in terms of the geographical recruitment area. Subjects who provided written informed consent prior to enrolment for the use of their personal identifier for linkage purposes to Finnish Registries.
Receives: Procedure: Screening for cervical cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of intraepithelial neoplasia grade 3 or worse (CIN3+). including CIN3, cervical cancer (squamous cell carcinoma or adenocarcinoma).

    To estimate the long-term vaccine efficacy by comparing the incidence rate of cervical cancers and pre-cancerous lesions (CIN3+) in Cohort A vs. Cohort C.

    Measured: The time frame is up to 15 years (for the interim analyses: 4, 7 and 10 years). (Start and end of passive follow-up, Cohorts A and B: 01.01.2010 - 31.12. 2024; Cohorts C1 and C2: 01.10.2007/01.10.2008 - 30.09.2021/30.09.2023.)

Secondary outcomes (1)

  1. Occurrence of potentially HPV related non-cervical cancers or pre cancerous lesions, including but not limited to the occurrence of vulvar intraepithelial neoplasia and vaginal intraepithelial neoplasia.

    To estimate the efficacy of HPV-16/18 vaccine against non-cervical cancers by comparing the incidence of non-cervical cancers in Cohort A vs. Cohort C.

    Measured: The time frame for the objectives of the study is up to 15 years. (Start and end of passive follow-up, Cohorts A and B: 01.01.2010 - 31.12. 2024; Cohorts C1 and C2: 01.10.2007/01.10.2008 - 30.09.2021/30.09.2023.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01393470
Sponsor's protocol ID
115006 (HPV-027)
Status last verified
May 2014
First submitted
5 Jul 2011
Last updated
15 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6.

    PubMed 19586656

  • Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter DL, Kitchener HC, Castellsague X, de Carvalho NS, Skinner SR, Harper DM, Hedrick JA, Jaisamrarn U, Limson GA, Dionne M, Quint W, Spiessens B, Peeters P, Struyf F, Wieting SL, Lehtinen MO, Dubin G; HPV PATRICIA study group. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet. 2007 Jun 30;369(9580):2161-2170. doi: 10.1016/S0140-6736(07)60946-5.

    PubMed 17602732

  • Lehtinen M, Idanpaan-Heikkila I, Lunnas T, Palmroth J, Barr E, Cacciatore R, Isaksson R, Kekki M, Koskela P, Kosunen E, Kuortti M, Lahti L, Liljamo T, Luostarinen T, Apter D, Pukkala E, Paavonen J. Population-based enrolment of adolescents in a long-term follow-up trial of human papillomavirus vaccine efficacy. Int J STD AIDS. 2006 Apr;17(4):237-46. doi: 10.1258/095646206776253453.

    PubMed 16595046

  • Lehtinen M, Paavonen J. Effectiveness of preventive human papillomavirus vaccination. Int J STD AIDS. 2003 Dec;14(12):787-92. doi: 10.1258/095646203322556084.

    PubMed 14678583

  • Lehtinen M, Apter D, Dubin G, Kosunen E, Isaksson R, Korpivaara EL, Kyha-Osterlund L, Lunnas T, Luostarinen T, Niemi L, Palmroth J, Petaja T, Rekonen S, Salmivesi S, Siitari-Mattila M, Svartsjo S, Tuomivaara L, Vilkki M, Pukkala E, Paavonen J. Enrolment of 22,000 adolescent women to cancer registry follow-up for long-term human papillomavirus vaccine efficacy: guarding against guessing. Int J STD AIDS. 2006 Aug;17(8):517-21. doi: 10.1258/095646206778145550.

    PubMed 16925896

Questions about this trial

What is this clinical trial studying?

An observational study of Uterine Cervical Cancer, run by Tampere University at 15 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of intraepithelial neoplasia grade 3 or worse (CIN3+). including CIN3, cervical cancer (squamous cell carcinoma or adenocarcinoma). (time frame: The time frame is up to 15 years (for the interim analyses: 4, 7 and 10 years). (Start and end of passive follow-up, Cohorts A and B: 01.01.2010 - 31.12. 2024; Cohorts C1 and C2: 01.10.2007/01.10.2008 - 30.09.2021/30.09.2023.)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01393470, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.

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