LTFU V503: Long-Term Follow-Up of Women Participating in the Phase III Clinical Trial with the 9-valent HPV Vaccine
Background:
The Gardasil 9 vaccine provides protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. HPV 6 and 11 cause genital warts, while HPV 16, 18, 31, 33, 45, 52, and 58 can lead to cancer. Approximately 90% of cervical cancer cases are caused by these HPV types.
From 2008 to 2013, over 4500 women in Sweden, Denmark, and Norway participated in the clinical vaccine study with Gardasil 9. About half of the participants received this 9-valent vaccine, while the other half were given the 4-valent vaccine Gardasil. Women who received Gardasil were offered Gardasil 9 after the study concluded (4 years later).
The study laid the groundwork for the U.S. Food and Drug Administration (FDA) approval of Gardasil 9 for commercial use in 2014. A requirement for the approval was ongoing monitoring of Gardasil 9's safety, effectiveness, and duration. The Nordic countries were chosen to conduct such a long-term study.
In this follow-up study, participants are tracked until 2025. About 630 women in Norway are participating. Participants are monitored through national health registries (Norway, Sweden, and Denmark) and regular blood samples (Denmark only). The study examines the vaccine's safety, protection, and duration up to 14 years after the original vaccination.
The latest results were published in 2021, showing that Gardasil 9 is a safe vaccine and there are no severe cervical cell changes caused by the HPV types the vaccine targets up to 8 years after vaccination. The immune response remains sustained for up to 9 years after vaccination.
Status:
There have been some delays in data and tissue sample collection due to the introduction of the General Data Protection Regulation (GDPR) in 2018, which led to changes in personal data protection law. As a result, new information was sent to 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.
The study collects 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. 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.
The latest collection of registry data and tissue samples covers the period 2018-2021, and the analyses are in progress. The next collection is scheduled for 2024-2025.
Participant Information:
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