If you take part in this study, you will need to follow the study vaccine plan, tests and clinic appointments explained in section 4 of the patient information sheet. There will be one additional visit at 24 months (2 years) that is not part of routine care in most clinics. There will be an additional visit at 2 months for the second dose of the vaccine for those that are randomised to the vaccine. You should consider how these tests and visits will affect your work and family life and decide if you are able to commit to them. The care team at your clinic will ask you questions about any side effects, new medication or health problems during your visits, or contact you over the phone. You will be able to contact them in between visits if there is anything important that you wish to report.  

If you are successfully enrolled in the study, whether you receive the vaccine or not: 

• The study doctor or nurse will discuss with you when to come to the clinic and return self-sampling swab kits. 

• You must be available for follow-up calls throughout the study to report any side effects or changes in medication or your health. 

• If randomised in the vaccine arm, you will receive the vaccine, as described below: 

Gardasil® 9 - (0.5ml) will be administered as a 3-dose (0, 2, 6 months) schedule. The vaccine will be administered as an intramuscular injection, usually in your upper arm or upper thigh. 

Females who are pregnant or intending to become pregnant during the next 6 months are not eligible to take part in the study. Gardasil® 9 is not recommended for use in pregnant women, although the vaccine has not been associated with adverse pregnancy or adverse events in the developing foetus. We will perform a pregnancy test before each dose for women receiving the vaccine. If a woman is found to be pregnant after initiating the vaccination series, the remainder of the 3-dose series should be delayed until completion of pregnancy. If a vaccine dose has been administered during pregnancy, no intervention is needed. Your pregnancy will be followed if you have given us the permission to do so during the informed consent. The pregnancy follow-up data will be shared with the Sponsor (Imperial College London) and the part funder (Merck Sharp and Dohme (MSD) Ltd). 

Women who are breastfeeding may be vaccinated. There is no data to suggest harmful effects on fertility. 

You will not be paid for taking part in the study. However, a contribution may be made towards travel expenditure for the additional visits. If you wish to find out more about this, please talk to your study doctor or nurse.   

This study will help us understand if Gardasil® 9 has any benefits for women after treatment. If proven to be beneficial and included in the national vaccination programme, this may lead to better prevention of cervical precancer and cancer in the future.  

You may benefit directly as a result of taking part in this study if the vaccine is proven to be effective in preventing persistent high-risk HPV infection after treatment. The administration of the vaccine after local treatment is currently not part of the national immunisation programme and is not provided outside of this clinical trial. 

It is important to have the routine clinical tests and the management recommended by your doctor. You will have additional research samples collected in the clinic, although the results of these will not be used for clinical management and will not be known to you. You may benefit indirectly from the closer monitoring during the additional visits. The Sponsor does not intend to provide you with financial or other personal benefits as a result of participating in the study.

You may not experience any additional health benefits during or following completion of this study. You may also experience side effects from the vaccine as mentioned in the Vaccine Side Effects. In addition, you may feel discomfort during some of the tests mentioned in What's Involved which may include: 

Swabs and/or smears: Although these will be done as part of your routine gynaecological examination their collection can cause discomfort, cramps and spotting.  Blood samples: As with all blood tests, there is a possibility of slight redness, inflammation and/or bruising developing at the site where the needle is placed into your arm. It is also possible that you may feel lightheaded or faint. Please tell the study doctor or nurse if you do not feel well after having your blood taken. 

If you decide not to take part in this study, your doctor will discuss routine follow-up that does not include vaccination. 

The study will end approximately 6 months after the last participant completes follow-up. After this point, Gardasil® 9 will not be available to patients in the clinic. In addition, Imperial College London (the sponsor), the trial’s Research Ethics Committee (REC), Regulatory Authority, or the pharmaceutical company supplying the vaccine (Merck MSD Ltd) may decide to stop the study for valid reasons not listed above. If this happens, your study doctor will discuss with you in full, including a plan for your future care as appropriate. 

Your doctor will be there to answer any questions you might have regarding the precancer, its treatment and your participation in the study. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, then there will be several options available to you.  

Yes. We will follow ethical and legal practice and all information about you will be handled in confidence.  Imperial College London is the sponsor for this study based in the United Kingdom. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Imperial College London will keep study information about you and we may collect long-term data on your health for up to 20 years after the study has completed in relation to primary research data. 

You must tell your doctor immediately if you no longer wish to take part in the study. Your doctor will discuss further management with you as appropriate. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will not collect any new information about you, but we will keep the information about you that we have already obtained including any optional research samples i.e. swabs, smears, blood and tissue samples unless you specifically withdraw your consent for their use. To safeguard your rights, we will use the minimum personally-identifiable information possible. Your study doctor can also stop study intervention at any time e.g. if this is clinically indicated, or another condition develops that may mean you are unable to carry on receiving study treatment.