Safety and Immunogenicity of HPV Vaccine in HIV-infected
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Indicators related to HIV infection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Healthy control vaccination group
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.
干预措施: HPV vaccination (Biological)
Healthy control non-vaccination group
Healthy participants were used merely as a control group and no intervention was carried out on them.
PLWH vaccination group
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.
干预措施: HPV vaccination (Biological)
PLWH ono-vaccination group
HIV-infected individuals were not vaccinated but were used as a control group.
结局指标
主要结局
Indicators related to HIV infection
时间窗: 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
时间窗: 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.
次要结局
- Incidence of adverse events and long-term safety(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(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.)
研究者
Fu-Sheng Wang
Chief Physician
Beijing 302 Hospital