HPV program: Perfect Use of Our Health Goldmine
Since 2009, The Cancer Registry of Norway has made use of health data in groundbreaking ways. They have taken the Nordic HPV vaccine program and turned it into a unique study using real world data. The project manager Mari Nygård hopes the study can inspire others to use health data in a similar ways and dig up ‘health treasures’ important to public health.
How the Project Started
HPV stands for “human papillomavirus” and is the most common sexually transmitted infection. The majority of those infected are not aware of this and most infections are harmless and do not give any symptoms. However, some HPV types can cause cancer and are called high risk HPV. The most well known being cervical cancer.
In the 2000s, the pharmaceutical company MSD developed the first vaccine to prevent the HPV virus and the cancers caused by it.
However, when the vaccine was approved, the US Food and Drug Administration (FDA) demanded that health data monitoring the effect and side-effects of the vaccine, had to be collected for 15 years because that’s the time it takes for a HPV infection to cause cell change and cervical cancer.
This led to MSD contacting the Cancer Registry. Together they, with other Nordic research communities, started monitoring the effect of the vaccine in Norway, Denmark, Sweden and Iceland.
Uses Real World Data
Mari Nygård, head of the Cancer Registry’s HPV-related epidemiological research unit, has managed the project from the beginning, and is proud of their contributions thus far.
— We monitor the effect of the vaccine by using real world data. Among other things, we are using health registries to follow up 10,000 participants for 15 years. Less than five per cent have dropped out so far. That is sensational. The study is really unique in a global context, says Nygård.
The goal of the study is to map side effects and endpoints. Endpoints can be vaccine-induced immune responses, precursors to cervical cancer or other types of cancer caused by the HPV included in the vaccine.
The researchers used the health registries to gather information regarding the endpoints and combined this with obtaining biological material from clinical bio-banks for virologic and pathomorphological analyses. In addition, blood samples were collected from the participants at regular intervals to test for vaccine-induced HPV antibodies.
In addition to several publications and a general competence boost regarding HPV for the Cancer Registry, the research has received great international recognition.
Important to Collaborate on Health Data
Nygård hopes that the HPV program can inspire others to conduct similar studies using health data.
— There is currently a great interest in health registry research, and we know that the information stored is a potential goldmine. Our collaboration with MSD proves that it is possible to find “health gold” beneficial to public health, and the industry can play an important part creating these solutions, says Nygård.
The pharmaceutical company MSD agrees, and is very pleased with the collaboration.
— The Cancer Registry has played an important global part in the development of MSD’s HPV vaccines. We are proud to have contributed to promoting the national registries during the collaboration, and believe this can be an example of how Norwegian data can be used in future drug development and drug follow-up, says Elen Høeg, responsible for vaccines at MSD.
Inven2’s Important Contribution
Inven2 has also been an important contributor to the project. The company has been responsible for getting the first agreements between The Cancer Registry and MSD in place.
— Agreeing on the first contract with MSD was a complex process, but we got there with Inven2’s help, says Nygård.