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NCT Number: NCT07314307

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

22 year–31 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Karolinska University Hospital

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 6 years

    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).

Secondary outcomes

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

    Time frame: 6 years

    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).

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

    Time frame: 6 years

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Acronym: FASTER1DOSE

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.