NCT07797894Not yet recruitingPhase 1/2
Safety and Immunogenicity of HPV Vaccine in HIV-infected
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 27 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Beijing 302 Hospital
- NCT number
- NCT07797894
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- From 1 Sept 2026 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
- Any other condition judged by the investigators to make enrollment inappropriate.
Other
- Pregnancy or lactation;
- HPV-positive participants;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fifth Medical Center of the PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.