Vaccine Effectiveness of One Dose of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Young-adult Women in Sweden Among Women Participating in a Clinical Trial of Concomitant HPV Vaccination and Screening

NCT07314307 | Active Not Recruiting Phase 4

• 1 other identifier: 2020-07145
• Study Type: interventional
• Target: 150,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the vaccine effectiveness of 1 dose the nonavalent human papillomavirus (HPV) vaccine against HPV16, 18, 31, 33, 45, 52, and 58 infection among young adult women in Sweden participating in a nationwide HPV elimination trial.

Conditions

Incident HPV16, 18, 31, 33, 45, 52 or 58 Infection

Keywords

HPV; Vaccine effectiveness; one dose; Even Faster

Outcome Measures

Primary Outcomes (1)

• HPV16, 18, 31, 33, 45, 51, 52, and 58 incident HPV infection

  Incidence rate of incident HPV16, 18, 31, 33, 45, 52 or 58 infection 3 years after receiving one dose of the nonavalent vaccine, among the 1994-1999 born women participating in the elimination trial nationwide at the time who were HPV negative at baseline (negative for the specific HPV type in the analysis).

  6 years

Secondary Outcomes (2)

• HPV16, 18, 31, 33, 45, 51, 52, and 58 incident HPV infection

  6 years

• HPV16, 18, 31, 33, 45, 51, 52, and 58 incident HPV infection

  6 years

Study Arms (2)

Concomitant HPV vaccination and screening intervention arm

EXPERIMENTAL

Eligible women were invited by letter, push notification (via their personal mobile telephones) to attend a vaccination site for concomitant HPV vaccination (with the nonavalent vaccine Gardasil 9) and HPV-based cervical screening (using a self-sample). After 3 years women who had received their first vaccine dose were invited to receive a second dose of the nonavalent HPV vaccine and to give a second screening sample.

Biological: Gardasil 9 2 dose regimen

Unvaccinated comparison group

NO INTERVENTION

The unvaccinated comparison group will be comprised of unvaccinated women attending routine screening in Sweden (whole trial or Stockholm region in the piloting phase).

Interventions

Gardasil 9 2 dose regimen BIOLOGICAL

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.

Concomitant HPV vaccination and screening intervention arm

Eligibility Criteria

• Age: 22 Years - 31 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: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible women will include resident women born between 1994-1999 (1993-1999 in the non intervention arm), who have not opted out of the screening program and who consent to participate in the study.

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

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

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 BACKGROUND

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent; Clinical Protocols

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Joakim Dillner, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: January 2, 2026
• Study Start: May 3, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol and statistical analysis plan are available.
• Access Criteria: Data can be shared with other researchers upon written request.

Locations

SE (1)