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Safety and Immunogenicity of HPV Vaccine in HIV-infected

Not Yet RecruitingPhase 1, Phase 2

Sponsor: Beijing 302 Hospital

Conditions: HIV-infected Individuals

Interventions: HPV vaccination

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Beijing, Beijing Municipality, China