LTFU V501: Extended Long-Term Follow-Up of Women Participating in the Cervical Cancer Vaccine Study (FUTURE II)

Background:

Gardasil is an HPV vaccine targeting HPV types 6, 11, 16, and 18. HPV 6 and 11 cause genital warts, while HPV 16 and 18 can lead to cancer.

As early as 2002, approximately 5500 young women in the Nordic countries participated in the clinical study "FUTURE II," a clinical trial involving the HPV vaccine. In Norway, 1698 women participated. About half of the women received the vaccine, while the other half were given a placebo, a dummy vaccine without active ingredients. The women who received the placebo were offered Gardasil after the study was completed (4 years later).

The study laid the groundwork for the U.S. Food and Drug Administration (FDA) approval of the vaccine for commercial use in 2006. A requirement for the approval was ongoing monitoring of the vaccine's safety, effectiveness, and duration. The Nordic countries were chosen to conduct such a long-term study.

In the initial follow-up study, the women were tracked until 2018 through national health registries and regular blood samples. The results showed that the vaccine has no serious side effects, provides nearly 100% protection against cervical cell changes caused by the HPV types the vaccine targets, and maintains a lasting immune response for up to 14 years.

Current Status:

The study has now been extended to ensure follow-up for up to 22 years after the original vaccination and is an extension of the previous long-term follow-up study. The delay was due to the introduction of the General Data Protection Regulation (GDPR) in 2018, which led to changes in the personal data protection law. As a result, new informed consent was obtained for all participants, in addition to measures to ensure compliance with privacy regulations in the transfer of biological material and data between the Nordic countries and the USA.

Only participants who received the vaccine (not the placebo) at the start of the FUTURE II study are included in this round. About 640 women in Norway are currently participating.

In 2022-23 and 2025, blood samples will be collected to measure immune responses and assess the need for a follow-up dose. Simultaneously, registry data from the Cervical Cancer Screening Program, Cancer Registry, Norwegian Patient Registry, and Cause of Death Registry, along with archived tissue samples from study participants who have undergone a histological test since the last analysis, will be collected. In each round, meetings are held with a Nordic Pathology Panel, consisting of 4 expert pathologists who examine the collected tissue samples. The samples are also tested for HPV. The analyses aim to investigate the vaccine's continued protection against HPV-related diseases.

Participant Information:

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About the project: 

Project leader

Thea E. Hetland Falkenthal

Projekt team

Tina Sture, Tom Erik Nilsen, Elen Johanne Lahlum og Marie Gulla 

Funding

The study is funded by the vaccine manufacturer MSD Norway.

Project Period

LTFU V501: 2009 - 2020 (completed)

LTFU V501 Extension: 2021 - 2026

REK: The studies have been approved by the Regional Committee for Medical and Health Research Ethics (ref. 2009/1027,  ref. 2013/1447) 

Scientific Project Titles

LTFU V501: Long-Term Follow-Up of Women Participating in the Cervical Cancer Vaccine Study (The FUTURE II study/V501 Protocol 015-00) (completed)

LTFU V501 Extension: Extension of Long-Term Follow-Up of Women Participating in the Cervical Cancer Vaccine Study (The FUTURE II study/V501 Protocol 015-00)