Plain-English translation of NCT05829629 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing , an experimental vaccine that uses a modified flu virus to help your immune system fight HPV16 infection and prevent it from developing into cervical cancer. The study will give some women the vaccine and others a placebo (inactive treatment) to compare how safe the medication is and how well it works. Researchers want to find the right dose and understand how your body responds to this new treatment.
HPV16 is a common virus that can lead to cervical cancer if it persists in your body. Currently, there are vaccines to prevent HPV infection, but there are no approved treatments to help people who already have HPV clear the infection on their own. This medication is being developed as a potential new way to activate your immune system to fight an existing HPV infection before it progresses to more serious cervical disease.
You likely qualify if…
You likely don't qualify if…
You will receive three doses of either the vaccine or placebo over a 12-week period. The first dose will be injected directly into your cervix during a clinic visit, and the next two doses will be injected into your muscle (like a typical vaccine). Between doses, you will have follow-up visits for blood tests and exams to monitor your safety and how your immune system is responding to the treatment. The study will track any side effects you experience and measure changes in your body's immune response to HPV.
AI-generated summary from trial data · Jul 6, 2026 · Not medical advice
Slovakia
Phase
Safety & dosing
Sponsor
BlueSky Immunotherapies GmbH
Enrollment target
~20 participants
Started
September 2023
Primary completion
September 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years – 49 Years
Sex
Female only
Last updated on clinicaltrials.gov in February 2025.
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Central contact
BlueSky Clinical Operations
BlueSky Immunotherapies GmbH
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