HPV InfectionPhase 4NCT04910802
Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
A Phase 4 study testing Gardasil9 in people with HPV Infection and CIN 2/3, run by Miriam Elfström at 1 site in Sweden.
Trial summary
The study aims to evaluate whether organised, concomitant HPV vaccination and HPV screening offered to all resident women aged 22-27 will result in a more rapid elimination of HPV infection in Sweden. This objective will be examined at the population level. Read more about this study
- Who is it for?
- Ages 22 to 27 years, women only
- Conditions the study is for
- HPV Infection, CIN 2/3, Cervical Cancer
- What is being tested?
- Gardasil9
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150,000 participants
- Where
- 1 siteSweden
- Study dates
- 3 May 2021to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 27 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Eligible women will include resident women within the age range of 22-26, who have not opted out of the screening program and who consent to participate in the study.
- Women who respond to the invitation and attend screening will be screened with HPV testing by the current routine practise. Women who consent to participate will also be offered HPV vaccination. The HPV vaccine (Gardasil 9) will be offered regardless of whether the woman reports having had prior vaccination with a first-generation vaccine (Gardasil 4) and regardless of screening test result.
Who cannot join
- Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine.For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate
- Known history of immune-related disorders
- Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
- Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
- Current pregnancy (reported)
- Women with a total hysterectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Cancer prevention, screening, and counseling unit, Regional Cancer Center of Stockholm-Gotland
Stockholm, 10239
Malin Vikström, BSN, +46(0)8-123 131 14, malin.vikstrom@sll.se
About this study
Official title: Concomitant HPV Vaccination and HPV Screening for Rapid Elimination of HPV Infection and Cervical Cancer in Sweden
The study aims to evaluate whether organised, concomitant HPV vaccination and HPV screening offered to all resident women aged 22-27 will result in a more rapid elimination of HPV infection in Sweden. This objective will be examined at the population level.
Read the detailed description
In Sweden, 150 women die of and 550 women are diagnosed with cervical cancer each year. The average age at diagnosis is about 55 years and every third woman is under 40 years of age. World-wide, there half a million new cases of cervical cancer each year. The underlying cause of cervical cancer is a human papillomavirus (HPV), an infection that can be prevented by vaccination. The first-generation vaccine protects against HPV infection of the two types (16 and 18) that cause to about 70% of all cervical cancer. Since 2015, a second-generation vaccine (Gardasil 9, Sanofi Pasteur MSD SNC) has been available that provides protection against 9 HPV types of which 7 types (16, 18, 31, 33, 35, 45, 52 and 58) cause 90% of all cervical cancer.
In 2016, the World Health Organization (WHO) called on the countries of the world to eliminate cervical cancer as a public health problem. On 17 November 2020, all 194 WHO member states adopted a global strategy to increase the rate of elimination of cervical cancer. The strategy involves three main actions: vaccination, screening, and treatment. In Sweden, girls have been offered school-based vaccination against HPV with Gardasil 4 since 2012. Starting in the autumn of 2020, schoolboys have also been offered vaccination. Since 2019, the second-generation vaccine has been used in the school-based vaccination program. Sweden's vaccination strategy means that the virus will be eliminated among individuals born in 2007 and beyond. It will thus take another 20 years before Sweden can stop the infection in Sweden. Today, the infection continues to spread only among young adults. Studies have shown that vaccination up to age 26 can be effective and within the European Union, 10 out of 29 countries have a so-called catch-up on vaccination program targeting women over the age of 20 but such a catch-up has not been formally introduced in Sweden.
The overall goal is to investigate whether offering women ages 22-26 years vaccination with Gardasil 9 in connection with screening may involve a faster eradication of cervical cancer as a public health problem in Sweden. A regional pilot study will be conducted in 2021 followed by a subsequent scale-up to other regions.
- Conditions
- HPV Infection, CIN 2/3, Cervical Cancer
- Being tested
- Gardasil9
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil9Biological
Concomitant vaccination and HPV screening. Gardasil9 will be administered using standard dosage. 1 dose at recruitment and the 2nd dose 3 years later.
| Study group | Role | What they receive |
|---|---|---|
| HPV-vaccination | Experimental | Women ages 22-26 will be offered concomitant vaccination (1 dose of Gardasil9) and HPV screening. A second dose of Gardasil9 will be administered 3 years later. Receives: Biological: Gardasil9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Measured: Measured at recruitment.
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Measured: Measured 3 years after recruitment, at the second cervical screening attendance.
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Measured: Measure 6 years after recruitment, at the third cervical screening attendance.
Secondary outcomes (4)
Number of women with histopathologically confirmed cervical intraepithelial neoplasia grade 2, 3, or cervical cancer (CIN2+)
CIN2+ measured through registry linkages, by HPV type in the lesion.
Measured: Measured at recruitment, and subsequently at 3 year intervals.
Consumption of resources
Number of screening and treatment visits.
Measured: Measured at recruitment, and subsequently at 3 year intervals.
Number of women with obstetrical complications
Obstetrical complications such as preterm births measured through registry linkages.
Measured: Measured at recruitment, and subsequently at 3 year intervals.
Number of women with cervical specimens found to be benign
Treatments for cervical abnormalities, measured as excised cervical specimens, found to be benign. Measured through registry linkages.
Measured: Measured at recruitment, and subsequently at 3 year intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start3 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All women in the targeted age-range will be offered vaccination in conjunction with screening.
- Masking
- None (open label)
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miriam Elfström
- Sponsor type
- Other government
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Miriam Elfström, Region Stockholm
- Investigators
- Joakim Dillner, MD, PhD, Study director, Karolinska University Hospital Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910802
- Sponsor's protocol ID
- Catch-up vaccination
- Status last verified
- Sep 2021
- First submitted
- 1 May 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Documents related to the study can be shared. Data, once collected, will be made available.
Publications
Arroyo Muhr LS, Gini A, Yilmaz E, Hassan SS, Lagheden C, Hultin E, Garcia Serrano A, Ure AE, Andersson H, Merino R, Elfstrom KM, Baussano I, Dillner J. Concomitant human papillomavirus (HPV) vaccination and screening for elimination of HPV and cervical cancer. Nat Commun. 2024 May 1;15(1):3679. doi: 10.1038/s41467-024-47909-x.
PubMed 38693149
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant HPV Vaccination and HPV Screening for Rapid Elimination of HPV Infection and Cervical Cancer in Sweden
- ClinicalTrials.gov ID
- NCT04910802
- Acronym / sponsor ID
- Catch-up vaccination
- Conditions
- HPV Infection, CIN 2/3, Cervical Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Miriam ElfströmOther government
- Collaborators
- Karolinska University Hospital
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate whether organised, concomitant HPV vaccination and HPV screening offered to all resident women aged 22-27 will result in a more rapid elimination of HPV infection in Sweden. This objective will be examined at the population level.
Detailed description
In Sweden, 150 women die of and 550 women are diagnosed with cervical cancer each year. The average age at diagnosis is about 55 years and every third woman is under 40 years of age. World-wide, there half a million new cases of cervical cancer each year. The underlying cause of cervical cancer is a human papillomavirus (HPV), an infection that can be prevented by vaccination. The first-generation vaccine protects against HPV infection of the two types (16 and 18) that cause to about 70% of all cervical cancer. Since 2015, a second-generation vaccine (Gardasil 9, Sanofi Pasteur MSD SNC) has been available that provides protection against 9 HPV types of which 7 types (16, 18, 31, 33, 35, 45, 52 and 58) cause 90% of all cervical cancer.
In 2016, the World Health Organization (WHO) called on the countries of the world to eliminate cervical cancer as a public health problem. On 17 November 2020, all 194 WHO member states adopted a global strategy to increase the rate of elimination of cervical cancer. The strategy involves three main actions: vaccination, screening, and treatment. In Sweden, girls have been offered school-based vaccination against HPV with Gardasil 4 since 2012. Starting in the autumn of 2020, schoolboys have also been offered vaccination. Since 2019, the second-generation vaccine has been used in the school-based vaccination program. Sweden's vaccination strategy means that the virus will be eliminated among individuals born in 2007 and beyond. It will thus take another 20 years before Sweden can stop the infection in Sweden. Today, the infection continues to spread only among young adults. Studies have shown that vaccination up to age 26 can be effective and within the European Union, 10 out of 29 countries have a so-called catch-up on vaccination program targeting women over the age of 20 but such a catch-up has not been formally introduced in Sweden.
The overall goal is to investigate whether offering women ages 22-26 years vaccination with Gardasil 9 in connection with screening may involve a faster eradication of cervical cancer as a public health problem in Sweden. A regional pilot study will be conducted in 2021 followed by a subsequent scale-up to other regions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All women in the targeted age-range will be offered vaccination in conjunction with screening.
| Arm | Type | Receives |
|---|---|---|
| HPV-vaccination | Experimental | Biological: Gardasil9Women ages 22-26 will be offered concomitant vaccination (1 dose of Gardasil9) and HPV screening. A second dose of Gardasil9 will be administered 3 years later. |
Who may qualify
- Ages
- 22 to 27 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Eligible women will include resident women within the age range of 22-26, who have not opted out of the screening program and who consent to participate in the study.
- Women who respond to the invitation and attend screening will be screened with HPV testing by the current routine practise. Women who consent to participate will also be offered HPV vaccination. The HPV vaccine (Gardasil 9) will be offered regardless of whether the woman reports having had prior vaccination with a first-generation vaccine (Gardasil 4) and regardless of screening test result.
Key exclusion criteria (6 listed)
- Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine.For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate
- Known history of immune-related disorders
- Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
- Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
- Current pregnancy (reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gardasil9Concomitant vaccination and HPV screening. Gardasil9 will be administered using standard dosage. 1 dose at recruitment and the 2nd dose 3 years later. | Biological | HPV-vaccination |
Primary outcome
Prevalence of HPV
Time frame: Measured at recruitment.
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Prevalence of HPV
Time frame: Measured 3 years after recruitment, at the second cervical screening attendance.
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Prevalence of HPV
Time frame: Measure 6 years after recruitment, at the third cervical screening attendance.
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
4 secondary outcomes
Number of women with histopathologically confirmed cervical intraepithelial neoplasia grade 2, 3, or cervical cancer (CIN2+)
Time frame: Measured at recruitment, and subsequently at 3 year intervals.
Consumption of resources
Time frame: Measured at recruitment, and subsequently at 3 year intervals.
Number of women with obstetrical complications
Time frame: Measured at recruitment, and subsequently at 3 year intervals.
Number of women with cervical specimens found to be benign
Time frame: Measured at recruitment, and subsequently at 3 year intervals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 38693149Arroyo Muhr LS, Gini A, Yilmaz E, Hassan SS, Lagheden C, Hultin E, Garcia Serrano A, Ure AE, Andersson H, Merino R, Elfstrom KM, Baussano I, Dillner J. Concomitant human papillomavirus (HPV) vaccination and screening for elimination of HPV and cervical cancer. Nat Commun. 2024 May 1;15(1):3679. doi: 10.1038/s41467-024-47909-x.
- Individual participant dataSharing planned: Yes. Documents related to the study can be shared. Data, once collected, will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joakim Dillner, MD, PhD study director
Karolinska University Hospital Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gardasil9 in people with HPV Infection and CIN 2/3, run by Miriam Elfström at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Elfström, PhD (+46703816277, miriam.elfstrom@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HPV (time frame: Measured at recruitment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.