HPV vaccination and screening for cervical cancer in young women in Sweden
Concomitant HPV Vaccination and HPV Screening for Rapid Elimination of HPV Infection and Cervical Cancer in Sweden
This study is testing whether giving the HPV vaccine and screening for cervical cancer at the same time can help young women in Sweden reduce HPV infections more quickly.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150000 (estimated) |
| Ages | 22 Years to 27 Years |
| Sex | Female |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT04910802 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of offering HPV vaccination and screening simultaneously to women aged 22-27 in Sweden. It aims to determine if this approach can lead to a faster reduction in HPV infections at the population level. The study utilizes the Gardasil 9 vaccine, which protects against multiple HPV types responsible for the majority of cervical cancer cases. Participants will be screened for HPV and offered vaccination regardless of their previous vaccination history or screening results.
Who should consider this trial
Good fit: Ideal candidates for this study are resident women aged 22-26 who have not opted out of the HPV screening program.
Not a fit: Patients with a known history of severe allergic reactions to the HPV vaccine components or immune-related disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of HPV infections and cervical cancer among young women in Sweden.
How similar studies have performed: Other studies have shown success with HPV vaccination and screening strategies, indicating a promising approach to cervical cancer prevention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 1. 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 2. Known history of immune-related disorders 3. Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever. 4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose 5. Current pregnancy (reported) 6. Women with a total hysterectomy
Where this trial is running
Stockholm
- Cancer prevention, screening, and counseling unit, Regional Cancer Center of Stockholm-Gotland — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Miriam Elfström, PhD
- Email: miriam.elfstrom@sll.se
- Phone: +46703816277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.