One shot may be enough: HPV vaccine study could change guidelines
NCT ID NCT07314307
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a single dose of the HPV vaccine (Gardasil 9) can protect young women from HPV infection. Over 150,000 women in Sweden are participating, receiving one vaccine dose along with routine screening. The goal is to see if one dose is effective enough to help eliminate HPV and reduce cervical cancer risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gardasil 9 (HPV vaccine)
- What this could lead to
- If one dose works as well as the full series, it could simplify HPV vaccination, making it easier and cheaper to prevent cervical cancer.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be less definitive. The study only follows women for 3 years, so long-term protection is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 150,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2021
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 31 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Incident HPV16, 18, 31, 33, 45, 52 or 58 infection are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Karolinska University Hospital
Stockholm, Sweden