Human Papillomavirus infection
Conditions
Interventions
HIV-infected group:Enroll 60 male HIV-infected individuals according to the inclusion criteria, and all study participants will receive the domestically produced 9-valent HPV vaccine (REC603)
Healthy control group:All study participants will receive the domestically produced 9-valent HPV vaccine (REC603).
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for HIV Individuals 1.Age 18-45 years, male, with a history of male-to-male sexual behavior (MSM); 2.Positive for HIV-1 antibody by ELISA and confirmed by Western Blot; 3.Has not received any HPV vaccine; 4.On ART for >=2 years and with sustained virological suppression (500 cells/mm^3 for enrollment in the well-reconstituted immune group; after ART, CD4 count <350 cells/mm^3 for enrollment in the poorly-reconstituted immune group; 6.Normal anal cytology result; 7.Willing to receive the domestic 9-valent HPV vaccine; 8.Willing to sign the informed consent form. Inclusion Criteria for Healthy Individuals 1.Age 18-45 years, male, with a history of male-to-male sexual behavior (MSM); 2.Has not received any HPV vaccine; 3.Negative for HIV-1 antibody by ELISA and confirmed by Western Blot; 4.Normal anal cytology result; 5.Willing to receive the domestic 9-valent HPV vaccine; 6.Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of HPV-related cancers, treatment for high-grade anal intraepithelial neoplasia or condyloma within the past 6 months; 2.Presence of opportunistic infections or AIDS-related malignancies at the time of blood sample collection; or occurrence of opportunistic infections within the 3 months prior to sampling, with unstable clinical conditions within the 2 weeks before sampling; 3.History of systemic immunosuppressive therapy; 4.Severe hepatic or renal insufficiency at the time of blood sample collection; 5.History of allergic reactions to previous vaccinations; 6.Administration of other vaccines within the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV Type-Specific Antibody Detection;Safety Endpoints;HPV Neutralizing Antibody Assay;Antigen-Specific T Cell Assay;Plasma Cytokine Assay; | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of Cytokine Concentrations in Mucosal Supernatants;Mucosal microbiota profiling;Functional prediction of the mucosal microbiota;Specific antibody detection in mucosal supernatants; | — |
Countries
China
Contacts
Public ContactYaxian Kong
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed