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NCT Number: NCT07797894

Safety and Immunogenicity of HPV Vaccine in HIV-infected

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.

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Key information

Conditions

HIV-Infected Individuals Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Fifth Medical Center of the PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HPV vaccination

Biological

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

    Adverse events; Blood routine test Liver and kidney functions

  2. 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.

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Beijing 302 Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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