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 (FASTER1DOSE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Incident HPV16, 18, 31, 33, 45, 52 or 58 Infection
• Intervention / Treatment: Biological: Gardasil 9 2 dose regimen

Detailed Description

HPV vaccination is the 1st pillar in the World Health Organization's (WHO) strategy to eliminate cervical cancer as public health problem, defined as an incidence of under 4 per 100,000 women-years globally. Licensed prophylactic HPV vaccines are highly efficacious in preventing HPV infection and associated cancers. At the time of licensure, the first-generation vaccines were licensed with a 3-dose schedule, and subsequently with a 2-dose schedule for women aged 15 and under. However, based on promising findings from observational studies of high vaccine effectiveness after only one dose, and subsequent clinical trials, the Strategic Advisory Group of Experts on Immunization (SAGE) recommended an off-label HPV vaccination regimen of one dose for girls and women from the age of 9 to 20 years-old. However, for women aged 21 or older a 2-dose schedule is still recommended by the WHO.

This nationwide trial of concomitant HPV vaccination among women aged 22 to 30-years-old in Sweden is a unique opportunity to evaluate the vaccine effectiveness of one dose of HPV vaccination among women over the age of 20 years old. Studies on the efficacy and effectiveness of one dose among women over the age of 20 years old are scarce and of varying quality. The findings of this study will be crucial to inform public health decision makers and in contributing to the evidence base for assessing if the 2-dose schedule recommendation among women over 20-years-old is still warranted.

• Study Type: Interventional
• Enrollment (Estimated): 150000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concomitant HPV vaccination and screening intervention arm; 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; 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.
No Intervention: Unvaccinated comparison group; The unvaccinated comparison group will be comprised of unvaccinated women attending routine screening in Sweden (whole trial or Stockholm region in the piloting phase).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 in the Stockholm region (the piloting phase), who were HPV negative at baseline (negative for the specific HPV type in the analysis).	6 years
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) in relation to their previous HPV vaccination history.	6 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Joakim Dillner, MD PhD, Karolinska Institutet

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine effectiveness; HPV; one dose; Even Faster
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Therapeutics; Health Care Evaluation Mechanisms; Quality of Health Care; Epidemiologic Study Characteristics; Human Papillomavirus Recombinant Vaccine nonavalent; Clinical Protocols
• Other Study ID Numbers: 2020-07145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Documents related to the study can be shared. Data, once collected, will be made available.
• IPD Sharing Time Frame: The study protocol and statistical analysis plan are available.
• IPD Sharing Access Criteria: Data can be shared with other researchers upon written request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No