About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

HPV vaccination
Biological/Vaccine
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.

Treatment groups

80 Participants

are divided into 4 treatment groups

Group A: Healthy control vaccination groupExperimental treatment 1 intervention

Group B: Healthy control non-vaccination groupNo intervention 0 interventions

Group C: PLWH vaccination groupExperimental treatment 1 intervention

Group D: PLWH ono-vaccination groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Indicators related to HIV infection

CD4+T lymphocyte count; HIV viral load

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.

2

Immunogenics-related indicators

Hpv-specific neutralizing antibody titer and Hpv-specific IgG antibody level.

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.

Secondary outcomes

1

Incidence of adverse events and long-term safety

Adverse events; Blood routine test Liver and kidney functions

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.

2

Cellular and humoral immunity

Proportion and function of T cell subsets; Expression levels of immune-related genes;

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.

Safety and Immunogenicity of HPV Vaccine in HIV-infected

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts