What is Involved?

WHAT IS INVOLVED?

If, after reading the study Patient Information Sheet, you decide you'd like to take part in the NOVEL study, you will be asked some ‘screening’ questions to ensure you are suitable for the trial. If, after answering the questions, it turns out that you are not eligible, you will not be able to join the trial. If you are eligible, you will be asked to read and sign the consent form to confirm that you understand the study and that you agree to participate.  

 There are two groups in this study as follows: 

  • Group 1 – 500 women will receive Gardasil® 9 vaccine at the time of local treatment, then 2 months after local treatment, and finally 6 months after local treatment; 

  • Group 2 – 500 women will not receive the vaccine at the time of local treatment, and be followed up within the study. 

Whether or not you receive the vaccine, you will remain in the study and be followed up the same way until the end of study visit which will be 24 months after your local treatment. 

 
If you are suitable for the study, then most of the procedures and tests you will have as part of the study are exactly the same as you would have if you were not taking part, with a few exceptions. 

Some examinations and tests done during this visit are standard whilst others are extra for the study, and this is explained below. 


The gynaecological examination and local treatment are part of the routine clinical care.


During your routine gynaecological examination, we will also collect swab(s)/smears from the cervix and genital area for research purposes. You will be asked if you agree to have blood samples taken; these are optional.


If you are randomised into the vaccination group, you will get your first vaccine on the day or during the first week after the local treatment and you will return at month 2 and 6 for the 2nd and 3rd injection of the vaccine. You will be asked to take a urine pregnancy test before each injection.


All participants will be followed up for a minimum of 24 months (2 years). 


The visit and gynaecological examination at 6 months is part of your routine care. At 12 and 18 months after treatment you will be sent a ‘self-sampling’ kit to collect a vaginal sample yourself with clear instructions how to do this. 


The self-sample is returned to us by post in a prepaid envelope. At 24 months you will be asked to attend an additional clinic appointment for a gynaecological examination. We may collect long-term data for up to 20 years after the treatment.

Share by: