AIN1, AIN2, AIN3, Anal Cancer, Genital Wart, Penile Cancer, PIN-1, PIN-2, PIN-3
Conditions
Brief summary
To evaluate the safety and tolerability of the 9vHPV vaccine in Chinese healthy male aged 9 to 45 years.
Interventions
BIOLOGICALPlacebo among 18-45 yrs
Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).
BIOLOGICALPlacebo among 9-17 yrs
Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).
Sponsors
Shanghai Bovax Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
9 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Adverse Events (AEs) | From Day 0 to Month 7 | Subjects with solicited and unsolicited AEs |
| Number of subjects with Severe adverse events (SAE) | From Day 0 to Month 12 | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by Geometric mean titer (GMT) | day 31 post last dose | Immunogenicity were assessed by the GMT of anti HPV6/11/16/18/33/45/52/58 neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 |
| Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by seroconversion rate | day 31 post last dose | Immunogenicity were assessed by the seroconversion rate of anti HPV6/11/16/18/33/45/52/58 neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seronegative before vaccination |
| Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by IgG antibody GMT and seroconversion rate | day 31 post last dose | Immunogenicity were assessed by the seroconversion rate and GMT of anti HPV6/11/16/18/33/45/52/58 IgG antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seronegative before vaccination |
| The immunogenicity of subjects receiving 3 doses of vaccination was assessed by IgG antibodies and neutralizing antibodies | day 31 post last dose | Immunogenicity were assessed by the seroconversion rate and GMT (4-fold increase rate) of anti HPV6/11/16/18/33/45/52/58 IgG and neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seropositive before vaccination |
Countries
China
Outcome results
None listed