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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Gender eligibility is based on the sex coded in the personal identification number used in civil society in Sweden.
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| Name | Affiliation | Role |
|---|---|---|
| Joakim Dillner, MD PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38693149 | Background | 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. |
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Documents related to the study can be shared. Data, once collected, will be made available.
The study protocol and statistical analysis plan are available.
Data can be shared with other researchers upon written request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2025 |
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| 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 |
| Dec 17, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000634046 | Human Papillomavirus Recombinant Vaccine nonavalent |
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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