HPV2-2303 - Phase 2 clinical trial evaluating secondary HPV vaccination after treatment of high-grade cervical lesions

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Oscar Lambret

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

24 Dec 2024 → ongoing

Decision date (initial)

2024-10-21

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To estimate the proportion of HPV-negative status within two years of the initial positive HPV control test, in women over 45 years old who are chronic HPV carriers, after treatment for high-grade cervical intraepithelial lesion and HPV vaccination.

Secondary objectives 7

1. To describe the dynamics of HPV viral clearance in chronic HPV carrier patients receiving HPV vaccination.
2. To assess the safety of HPV vaccination
3. To estimate the incidence of recurrence of high-grade cervical intraepithelial lesions in chronic HPV carriers after surgical treatment of the initial lesion and HPV vaccination.
4. To estimate the incidence of invasive gynaecological cancer (cervix, vagina or vulva) in chronic HPV carriers after surgical treatment of the initial lesion and HPV vaccination.
5. To identify factors associated with refusal of vaccination (smoking, parity, body mass index, employment status, education level, family medical history, marital status, etc.).
6. To describe compliance with the proposed vaccination schedule in terms of : o Number of injections received o Compliance with the timing of injections
7. To assess the effect of vaccination on o HPV-negative status within two years o the dynamics of HPV viral clearance o controlling of the risk of recurrence of high-grade cervical intraepithelial lesions o the risk of suffering from invasive gynaecological cancer (cervix, vagina or vulva) by comparing vaccinated patients included in the clinical trial with the cohort of unvaccinated patients (refusal of HPV vaccination or other reason)

Conditions and MedDRA coding

high-grade cervical intraepithelial lesions

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Patient aged over 45
2. Patient treated by conisation for a high-grade cervical lesion
3. Positive HPV test at the recommended 6-month post-operative follow-up (a delay of 6 to 12 months will be accepted) leading to an indication for a follow-up colposcopy (+/- biopsy) in accordance with standard surveillance practices.
4. For cohort "vaccinated patients" : No contraindication to HPV vaccination with Gardasil 9
5. For cohort "vaccinated patients" : Patient who has consented to HPV vaccination with Gardasil 9
6. For cohort "vaccinated patients": Affiliated to a public health insurance program
7. For cohort "vaccinated patients" : Signed, informed consent form
8. For cohort "non-vaccinated patients" : Refusal of vaccination or contraindication to vaccination
9. For cohort "non vaccinated patients" : Non-objection to the use of their personal data for research purposes

Exclusion criteria 6

1. History of primary vaccination
2. History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal)
3. For cohort “vaccinated patients” : Patient refusing vaccination
4. For cohort " vaccinated patients" : Patient with a contraindication to HPV vaccination with Gardasil 9
5. For cohort "vaccinated patients" : Patient deprived of liberty or under guardianship
6. For cohort “non-vaccinated patients”: Objection to the use of their personal data for research purposes

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. HPV-negative status within 24 months of the initial HPV control test, HPV-negative statu is defined as a negative. If the patient cannot be assessed at 2 years due to the occurrence of cancer beforehand, the observation will be considered a failure (equivalent to the absence of negativation).

Secondary endpoints 5

1. HPV status over time assessed by smear every 12 months until HPV-negative status (in the study: within 5 years of follow-up). When the test is negative, a follow-up smear is performed three years later (in the study: within 5 years of follow-up).
2. Adverse Events (AEs) will be assessed according to the NCI-CTCAE V5.0 over the total duration of the vaccination schedule plus 30 days. AEs will be collected after each injection, at the next injection for the first 2 injections, and by a telephone call (+/- consultation if necessary) at 30 days after the 3rd injection. AEs clearly related to the underlying disease or its progression will be excluded. Grade ≥3 AEs will be considered as severe AEs. All serious adverse events will be reported im
3. To estimate the incidence of recurrence of high-grade intraepithelial lesion, we will calculate the time between the date of the initial HPV control test and the first of the event (recurrence of high-grade intraepithelial lesion of the uterine cervix, occurrence of HPV-related cancer whatever the location: uterine cervix, vagina, vulva).
4. To estimate the incidence of invasive gynaecological cancer (cervix, vagina or vulva), we will calculate the time between the date of the initial HPV control test and the occurrence of HPV-related invasive cancer at any location (cervix, vagina, vulva).
5. Compliance with the vaccination schedule will be assessed by o the number of injections received o the timing of injections (time to start vaccination, time between each injections, time between the 1st and 3rd injections).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Oscar Lambret

Sponsor organisation

Centre Oscar Lambret

Address

3 Rue Frederic Combemale

City

Lille

Postcode

59000

Country

France

Scientific contact point

Organisation

Centre Oscar Lambret

Contact name

Cinical Research Sponsor Unit

Public contact point

Organisation

Centre Oscar Lambret

Contact name

Cinical Research Sponsor Unit

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications