Safety and Immunogenicity of HPV Vaccine in HIV-infected

NCT07797894 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: KY-2026-4-63-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV-infected Individuals

Keywords

HPV, HIV, Vaccination, Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Indicators related to HIV infection

  CD4+T lymphocyte count; HIV viral load

  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.

• Immunogenics-related indicators

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

  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 (2)

• 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.

Study Arms (4)

Healthy control vaccination group

EXPERIMENTAL

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.

Biological: HPV vaccination

Healthy control non-vaccination group

NO INTERVENTION

Healthy participants were used merely as a control group and no intervention was carried out on them.

PLWH vaccination group

EXPERIMENTAL

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.

Biological: HPV vaccination

PLWH ono-vaccination group

NO INTERVENTION

HIV-infected individuals were not vaccinated but were used as a control group.

Interventions

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.

Healthy control vaccination group; PLWH vaccination group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The Fifth Medical Center of the PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yunbo Xie, Doctor

CONTACT

+86 15110140963; 15110140963@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-07

Locations

CN (1)