NCT05518201已完成1 期
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
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of subjects with Severe adverse events (SAE)
研究概览
简要总结
To evaluate the safety and tolerability of the 9vHPV vaccine in Chinese healthy male aged 9 to 45 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Years 至 45 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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;
- •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;
- •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;
- •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.
排除标准
- •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℃);
- •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);
- •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;
- •History of positive test to HPV (including types not covered by 9vHPV vaccine);
- •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;
- •Present history of severe liver and kidney disease, severe CVDs, severe hypertension, diabetic complications, or history of malignant tumour;
- •History of convulsions (except fever convulsions in children under 2 years of age), epilepsy, brain diseases, mental illness, or family history;
- •With prohibitive contraindications to intramuscular injection, such as Thrombocytopenia, coagulopathy, or being treated with anticoagulants;
- •Asplenic, functionally asplenic, or splenectomy caused by any condition;
- •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);
- •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.);
- •Present history of infectious diseases, such as Tuberculosis (TB), Hepatitis, HIV infection, and/or TeponemaPllidum infection;
- •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.);
- •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;
- •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;
- •Plan to receive immunoglobulin products or blood-related products during this study period (From Day 0 to Month 7);
- •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);
- •Abnormal laboratory testing indicators specified in study protocol (except NCS);
- •According to the investigator's judgment, the subjects had any condition that were not suitable for participation in this study.
研究组 & 干预措施
The 9vHPV Recombinant Vaccine among 18-45yrs
Experimental
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5mL/each dose).
干预措施: Placebo among 18-45 yrs (Biological)
The 9vHPV Recombinant Vaccine among 9-17 yrs
Experimental
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5mL/each dose).
干预措施: Placebo among 9-17 yrs (Biological)
结局指标
主要结局
Number of subjects with Severe adverse events (SAE)
时间窗: 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.
Number of subjects with Adverse Events (AEs)
时间窗: From Day 0 to Month 7
Subjects with solicited and unsolicited AEs
次要结局
- Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by Geometric mean titer (GMT)(day 31 post last dose)
- 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)
- The immunogenicity of subjects receiving 3 doses of vaccination was assessed by IgG antibodies and neutralizing antibodies(day 31 post last dose)
- Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by seroconversion rate(day 31 post last dose)
研究者
研究点 (1)
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