Can the HPV vaccine protect those with HIV from cancer?
NCT ID NCT07797894
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests whether the 9-valent HPV vaccine is safe and triggers a protective immune response in adults with HIV. People with HIV face higher risks of HPV infection and related cancers, but vaccine research in this group is limited. The study enrolls 60 HIV-infected adults and 20 healthy controls, giving three doses over six months and following participants for two years. Researchers will measure antibody levels, immune cell responses, and side effects to see if the vaccine works as well in HIV-infected individuals as in healthy people.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 9-valent human papillomavirus (HPV) vaccine
- What this could lead to
- If the vaccine proves safe and effective in people with HIV, it could help prevent HPV-related cancers in this higher-risk group and guide vaccination guidelines.
- What could go wrong
- This is an early-stage trial with a small number of participants, so results may not apply to everyone. The vaccine might not produce a strong immune response in people with advanced HIV, and side effects are possible.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- 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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18 to 45 years
- Sex
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Anyone
- 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: * HIV-1 infection, aged 18-45 years; * On antiretroviral therapy (ART) for more than 1 year; * HIV RNA ≤1000 copies/mL; * No concurrent opportunistic infections; * Willing to comply with all study requirements prior to undergoing any study-related procedures; * Not participating in other clinical trials during the study period; * Able to understand and sign the informed consent form. Exclusion Criteria: * Pregnancy or lactation; * HPV-positive participants; * HIV-2 mono-infection; * Coexisting severe organic diseases or psychiatric disorders, including coronary heart disease, cerebrovascular disease, uncontrolled malignant hypertension, diabetes mellitus, history of epilepsy, or malignant tumors; * Evidence of drug addiction within 6 months prior to enrollment, or a positive urine toxicology screen; * History of prior HPV vaccination or of severe allergic reactions; * Current participation in other clinical trials that may compromise the study treatment plan or the assessment of outcome measures; * Anticipated insufficient adherence to participation in this clinical study; * Any other condition judged by the investigators to make enrollment inappropriate.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Fifth Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, 100039, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.