Clinical trial NCT05518201: Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old
Official title: Evaluate the Safety and Immunogenicity of the 9-valent Human Papillomavirus Recombinant Vaccine (Hansenula Polymorpha) in Chinese Male Aged 9-45 Years: A Randomized, Blinded and Placebo-Controlled Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Penile Cancer
Anal Cancer
PIN-1
PIN-2
PIN-3
AIN1
AIN2
AIN3
Genital Wart
Lead sponsor: Shanghai Bovax Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 90
Sex: MALE
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Number of subjects with Adverse Events (AEs)
timeFrame: From Day 0 to Month 7
measure: Number of subjects with Severe adverse events (SAE)
timeFrame: From Day 0 to Month 12
Secondary outcomes:
measure: Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by Geometric mean titer (GMT)
timeFrame: day 31 post last dose
measure: Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by seroconversion rate
timeFrame: day 31 post last dose
measure: Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by IgG antibody GMT and seroconversion rate
timeFrame: day 31 post last dose
measure: The immunogenicity of subjects receiving 3 doses of vaccination was assessed by IgG antibodies and neutralizing antibodies
timeFrame: day 31 post last dose
Other outcomes:
Locations:
city: Mianzhu
country: China
facility: Center for Disease Control and Prevention
state: Sichuan
Study officials:
affiliation: Sichuan Provincial Center for Disease Control and Prevention
name: Ting Huang
role: STUDY_DIRECTOR
References: