HIV-infected IndividualsPhase 1/2NCT07797894
Safety and Immunogenicity of HPV Vaccine in HIV-infected
A Phase 1/2 study testing HPV vaccination in people with HIV-infected Individuals, run by Beijing 302 Hospital at 1 site in China.
Trial summary
HPV can cause various cancers, including cervical cancer. HIV-infected individuals, due to immune deficiency or long-term immunosuppressive therapy, have significantly higher rates of HPV infection and associated lesion risks compared to the general population. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-infected Individuals
- What is being tested?
- HPV vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fifth Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, 100039
Fusheng Wang, Doctor, +86-010-66933332, fswang302@163.com
About this study
HPV can cause various cancers, including cervical cancer. HIV-infected individuals, due to immune deficiency or long-term immunosuppressive therapy, have significantly higher rates of HPV infection and associated lesion risks compared to the general population. However, clinical research on vaccines for HIV-infected individuals is still in its early stages. This study aims to investigate the safety, immunogenicity, and immune response mechanisms of HPV vaccines in HIV-infected populations. A single-center, prospective, open-label cohort study was conducted, enrolling 60 HIV-infected participants and 20 healthy controls, who received vaccinations according to a 0-, 1-, and 6-month schedule and were followed up for two years. Adverse events were monitored using CTCAE 5.0 criteria, while humoral and cellular immune responses were assessed using pseudovirus neutralization assays, mass cytometry, high-throughput gene sequencing, ELISA, and other techniques. By integrating data on HIV-related biomarkers, host genetic factors, and immune pathway analyses, we aimed to elucidate the underlying mechanisms of vaccine response. The study sought to define the safety profile of the vaccine in HIV-infected individuals, explore the impact of CD4+ cell count and ART regimens on immune responses, and establish a stratified vaccination strategy based on immune status. These findings are expected to provide critical data support and practical guidance for vaccine application in special populations, offering evidence-based insights for developing consensus and guidelines on HPV vaccination for HIV-infected individuals and enhancing the global public health impact of vaccines.
- Conditions
- HIV-infected Individuals
- Being tested
- HPV vaccination
- Keywords
- HPV, HIV, Vaccination, Immunogenicity
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccinationBiological
The participants received one dose of the 9-valent human papillomavirus vaccine (Cecolin 9) at 0 months (baseline), 1 month, and 6 months, with the injection site being the deltoid muscle of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control vaccination group | Experimental | In the 0th month (baseline), the 1st month, and the 6th month, healthy participants were each administered one dose of the 9-valent human papillomavirus vaccine (Cecolin 9) at a volume of 0.5ml, with the injection site being intramuscular injection in the deltoid muscle of the upper arm. Receives: Biological: HPV vaccination |
| Healthy control non-vaccination group | No intervention | Healthy participants were used merely as a control group and no intervention was carried out on them. |
| PLWH vaccination group | Experimental | HIV-infected individuals received one dose of the 9-valent human papillomavirus vaccine (Cecolin 9) at 0 months (baseline), 1 month, and 6 months. The injection site was intramuscular injection in the deltoid muscle of the upper arm. Receives: Biological: HPV vaccination |
| PLWH ono-vaccination group | No intervention | HIV-infected individuals were not vaccinated but were used as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indicators related to HIV infection
CD4+T lymphocyte count; HIV viral load
Measured: The participants were followed up at baseline (at the 0th month, before vaccination), at the 1st month, 6th month， 7th month， 12th month and at the 24th month to measure the CD4+T lymphocyte count and HIV viral load of the HIV-infected individuals.
Immunogenics-related indicators
Hpv-specific neutralizing antibody titer and Hpv-specific IgG antibody level.
Measured: The participants were followed up at baseline， 1st month, 6th month, 7th month, 12th month and at the 24th month to detect the titers of HPV-specific neutralizing antibodies and the levels of HPV-specific IgG antibodies.
Secondary outcomes (2)
Incidence of adverse events and long-term safety
Adverse events; Blood routine test Liver and kidney functions
Measured: The participants were followed up at baseline (at the 0th month, before vaccination), at the 1st month, at the 6th month, at the 7th month, at the 12th month, and at the 24th month to analyze adverse events, blood routine, liver and kidney functions.
Cellular and humoral immunity
Proportion and function of T cell subsets; Expression levels of immune-related genes;
Measured: The participants were followed up at baseline (at the 0th month, before vaccination), at the 1st month, at the 6th month, at the 7th month, at the 12th month, and at the 24th month to analyze cellular and humoral immunity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infected IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu-Sheng Wang, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797894
- Sponsor's protocol ID
- KY-2026-4-63-2
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of HPV Vaccine in HIV-infected
- ClinicalTrials.gov ID
- NCT07797894
- Acronym / sponsor ID
- KY-2026-4-63-2
- Conditions
- HIV-infected Individuals
- Keywords
- HPV, HIV, Vaccination, Immunogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HPV can cause various cancers, including cervical cancer. HIV-infected individuals, due to immune deficiency or long-term immunosuppressive therapy, have significantly higher rates of HPV infection and associated lesion risks compared to the general population. However, clinical research on vaccines for HIV-infected individuals is still in its early stages. This study aims to investigate the safety, immunogenicity, and immune response mechanisms of HPV vaccines in HIV-infected populations. A single-center, prospective, open-label cohort study was conducted, enrolling 60 HIV-infected participants and 20 healthy controls, who received vaccinations according to a 0-, 1-, and 6-month schedule and were followed up for two years. Adverse events were monitored using CTCAE 5.0 criteria, while humoral and cellular immune responses were assessed using pseudovirus neutralization assays, mass cytometry, high-throughput gene sequencing, ELISA, and other techniques. By integrating data on HIV-related biomarkers, host genetic factors, and immune pathway analyses, we aimed to elucidate the underlying mechanisms of vaccine response. The study sought to define the safety profile of the vaccine in HIV-infected individuals, explore the impact of CD4+ cell count and ART regimens on immune responses, and establish a stratified vaccination strategy based on immune status. These findings are expected to provide critical data support and practical guidance for vaccine application in special populations, offering evidence-based insights for developing consensus and guidelines on HPV vaccination for HIV-infected individuals and enhancing the global public health impact of vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy control vaccination group | Experimental | Biological: HPV vaccinationIn the 0th month (baseline), the 1st month, and the 6th month, healthy participants were each administered one dose of the 9-valent human papillomavirus vaccine (Cecolin 9) at a volume of 0.5ml, with the injection site being intramuscular injection in the deltoid muscle of the upper arm. |
| Healthy control non-vaccination group | No intervention | –Healthy participants were used merely as a control group and no intervention was carried out on them. |
| PLWH vaccination group | Experimental | Biological: HPV vaccinationHIV-infected individuals received one dose of the 9-valent human papillomavirus vaccine (Cecolin 9) at 0 months (baseline), 1 month, and 6 months. The injection site was intramuscular injection in the deltoid muscle of the upper arm. |
| PLWH ono-vaccination group | No intervention | –HIV-infected individuals were not vaccinated but were used as a control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV vaccinationThe participants received one dose of the 9-valent human papillomavirus vaccine (Cecolin 9) at 0 months (baseline), 1 month, and 6 months, with the injection site being the deltoid muscle of the upper arm. | Biological | Healthy control vaccination group, PLWH vaccination group |
Primary outcome
Indicators related to HIV infection
Time frame: The participants were followed up at baseline (at the 0th month, before vaccination), at the 1st month, 6th month， 7th month， 12th month and at the 24th month to measure the CD4+T lymphocyte count and HIV viral load of the HIV-infected individuals.
CD4+T lymphocyte count; HIV viral load
Immunogenics-related indicators
Time frame: The participants were followed up at baseline， 1st month, 6th month, 7th month, 12th month and at the 24th month to detect the titers of HPV-specific neutralizing antibodies and the levels of HPV-specific IgG antibodies.
Hpv-specific neutralizing antibody titer and Hpv-specific IgG antibody level.
2 secondary outcomes
Incidence of adverse events and long-term safety
Time frame: The participants were followed up at baseline (at the 0th month, before vaccination), at the 1st month, at the 6th month, at the 7th month, at the 12th month, and at the 24th month to analyze adverse events, blood routine, liver and kidney functions.
Cellular and humoral immunity
Time frame: The participants were followed up at baseline (at the 0th month, before vaccination), at the 1st month, at the 6th month, at the 7th month, at the 12th month, and at the 24th month to analyze cellular and humoral immunity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HPV vaccination in people with HIV-infected Individuals, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunbo Xie, Doctor (+86 15110140963, 15110140963@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indicators related to HIV infection (time frame: The participants were followed up at baseline (at the 0th month, before vaccination), at the 1st month, 6th month， 7th month， 12th month and at the 24th month to measure the CD4+T lymphocyte count and HIV viral load of the HIV-infected individuals.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.