evaluate the safety and immunogenicity of a 9-valent hpv vaccine in chinese healthy male aged 9-45 year-old

Conditions: Penile Cancer; Anal Cancer; PIN-1; PIN-2; PIN-3; AIN1; AIN2; AIN3; Genital Wart

Summary: to evaluate the safety and tolerability of the 9vhpv vaccine in chinese healthy male aged 9 to 45 years.


Eligibility criteria:
inclusion criteria: 1. healthy chinese male aged 9 to 45 years; provide legal identification; for those under the age of 18, they must also provide their guardian's legal identification; 2. adults voluntarily agrees to enroll in this study. if the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form; 3. subjects and/or their legal guardian are able to read and understand the study schedule, and commitment to regular follow-up as required by the study; 4. subjects will take effective contraception from day 0 to month 7 (for male: celibate, wear a condom, vasectomy, etc. ; for female sexual partners: use iud, oral/injecting/slow-release topical contraceptives (except emergency contraceptives), hormone patches, sterilization, contraceptive diaphragm, etc. exclusion criteria: 1. subjects aged over 14 years on the day of enrolment had fever (axillary temperature≥37.3℃) within 24 hours prior to the first dose of vaccination; subjects aged≤14 had fever within 24 hours prior to the first dose of vaccination (axillary temperature≥37.5℃); 2. poor controlled hypertension, i.e., after lifestyle modification and/or treated (aged 9 to 17 years: systolic bp≥120mmhg and/or diastolic bp≥80mmhg; aged 18 to 45 years: systolic bp≥140mmhg and/or diastolic bp ≥90mmhg); 3. had received marketed hpv vaccine; plan to receive marketed hpv vaccine during this study period; have enrolled in hpv vaccine clinical trials and have received trial vaccine/placebo; 4. history of positive test to hpv (including types not covered by 9vhpv vaccine); 5. history of external genital disease (e.g. genital warts, penis/perianal region/perineum intraepithelial neoplasia, penile/perianal/perineal cancer), diseases within the anus (e.g. anal intraepithelial neoplasia and anal cancer), or history of head and neck cancer; 6. present history of severe liver and kidney disease, severe cvds, severe hypertension, diabetic complications, or history of malignant tumour; 7. history of convulsions (except fever convulsions in children under 2 years of age), epilepsy, brain diseases, mental illness, or family history; 8. with prohibitive contraindications to intramuscular injection, such as thrombocytopenia, coagulopathy, or being treated with anticoagulants; 9. asplenic, functionally asplenic, or splenectomy caused by any condition; 10. history of severe allergic reactions requiring medical intervention (e.g., anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction (arthus reaction), etc.); history of severe side effects or a history of severe allergies to any of the components of the vaccine (histidine, polysorbate 80, aluminum phosphate adjuvant); 11. history of congenital/acquired immunodeficiency, such as lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases, etc.; received immunosuppressive treatment within 6 months before vaccination, such as long-term glucocorticoid use (dosage reference: equivalent to prednisone 20mg per day, more than one week); or monoclonal antibodies; or thymus peptides; or interferon, etc.; or plan to receive such products during this study period (from day 0 to month 7); allow topical medication (e.g., ointments, eye drops, inhalants, or nasal sprays, etc.); 12. present history of infectious diseases, such as tuberculosis (tb), hepatitis, hiv infection, and/or teponemapllidum infection; 13. within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.); 14. inactivated/recombinant/nucleic acid vaccines, etc. (non-attenuated vaccines) have been given within 14 days before enrollment; or have been vaccinated within 28 days of attenuated vaccines; or have received immunoglobulin products or blood-related products within 3 months before enrollment; 15. received other investigative or unregistered products within 30 days before vaccination or plan to receive such products during this study period; or still participating in other clinical trial within 3 months prior to enroll this study; 16. plan to receive immunoglobulin products or blood-related products during this study period (from day 0 to month 7); 17. plan to relocate permanently from the area before the end of the study or leave the local area for a long time during the study visit (affecting the scheduled visit time); 18. abnormal laboratory testing indicators specified in study protocol (except ncs); 19. according to the investigator's judgment, the subjects had any condition that were not suitable for participation in this study.