Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden

NCT04910802 | Recruiting Phase 4

• 1 other identifier: Catch-up vaccination
• Study Type: interventional
• Target: 150,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HPV Infection; CIN 2/3; Cervical Cancer

Outcome Measures

Primary Outcomes (3)

• 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 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 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.

  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+)

  Measured at recruitment, and subsequently at 3 year intervals.

• Consumption of resources

  Measured at recruitment, and subsequently at 3 year intervals.

• Number of women with obstetrical complications

  Measured at recruitment, and subsequently at 3 year intervals.

• Number of women with cervical specimens found to be benign

  Measured at recruitment, and subsequently at 3 year intervals.

Study Arms (1)

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.

Biological: Gardasil9

Interventions

Gardasil9 BIOLOGICAL

Concomitant vaccination and HPV screening. Gardasil9 will be administered using standard dosage. 1 dose at recruitment and the 2nd dose 3 years later.

HPV-vaccination

Eligibility Criteria

• Age: 22 Years - 27 Years
• Gender Eligibility Details: Gender eligibility is based on the sex coded in the personal identification number used in civil society in Sweden
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Miriam Elfström: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Cancer prevention, screening, and counseling unit, Regional Cancer Center of Stockholm-Gotland

Stockholm, 10239, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 38693149 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Joakim Dillner, MD, PhD

  Karolinska University Hospital Laboratory

  STUDY DIRECTOR

Central Study Contacts

Miriam Elfström, PhD

CONTACT

+46703816277; miriam.elfstrom@sll.se

Helena Andersson, PhD

CONTACT

+46768871126; helena.t.andersson@sll.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief development officer

Model Details: All women in the targeted age-range will be offered vaccination in conjunction with screening.

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: June 2, 2021
• Study Start: May 3, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The study protocol and informed consent form are available. The SAP will be made available and the analytic code will be available once the first round of results have been analyzed.
• Access Criteria: Data can be shared with other researchers upon written request. Possibilities to share the data on a digital platform will be investigated.

Locations

SE (1)