To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

Official title

A Randomised, Double-blind, Placebo and Positive Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity of 15-valent Human Papillomavirus Recombinant Vaccine (Hansenulapolymorpha) in Healthy Chinese People Aged 9-45 Years

Overview

To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.

Detailed description

A Randomized, double-blind, placebo and positive controlled trial is planned in 330 healthy participants across two age groups (18-45 years and 9-17 years) to evaluate the safety and immunogenicity of the 15-valent HPV vaccine.

Interventions

• Biological Medium dose for 15-HPV vaccine
  Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
• Biological High dose for 15-HPV vaccine
  Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
• Biological Placebo
  Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
• Biological 9-HPV vaccine
  Participants aged 9-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Primary outcome measures

• Percentage of Participants With Adverse Events [Time frame: Up to 30 minutes after any vaccination]
• Percentage of Participants With Solicited Adverse Events [Time frame: Up to 14 days after any vaccination]
• Percentage of Participants With Unsolicited Adverse Events [Time frame: Up to 30 days after any vaccination]
• Percentage of Participants With Serious Adverse Events [Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose]
• Percentage of Female Participants With Pregnancy Events [Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose]

Secondary outcome measures (3)

• Immunogenicity after receiving 3 doses of 15-HPV vaccine [Time frame: Up to 31 days after the third vaccination]
• Immunogenicity of 15-HPV vaccine [Time frame: Up to 31 days after the third vaccination]
• Immunogenicity after receiving 3 doses of 15-HPV vaccine among the participants [Time frame: Up to 31 days after the third vaccination]

Eligibility criteria

Inclusion criteria

• Participants aged 9-45；
• Participants aged 18-45 who can provide legal identification，participants aged 9-17 and their guardian can provide legal identification；
• Participants and/or their guardian sign an informed consent form;
• Axillary temperature less than 37.3 ℃（>14 years old）or less than 37.5℃（≤14 years old）at the time of enrollment；
• Be able to comply with study protocol requirements；
• Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study, and were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period, and had no birth plan within the 30 days after receiving the whole vaccination;
• Agree to take effective contraceptive measures within 30 days after receiving the whole vaccination (effective contraceptives include: oral contraceptives, injection or embedding contraceptives, sustained release topical contraceptives, hormone patches, intrauterine devices), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.

Exclusion criteria

• Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period；
• Plan to participate other clinical trials during the study period，or participated other clinical trials （including vaccine or drug）and received medication or vaccine within 3 months before enrollment ,
• History of positive HPV testing (including types not covered by the trial vaccine) among the participants aged 18-45 years old;
• History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy in female participants;
• History of HPV-related external genital diseases (such as genital warts, Vulvar intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Penis/perianal/perineum intraepithelial neoplasia, Penile/perianal/perineal cancer) 、anal intraepithelial neoplasia and related cancer, or head and neck cancer；history of sexually transmitted diseases (including syphilis， Gonorrhea, genital chlamydia infection, genital herpes, soft chancre, sexually transmitted lymphogranuloma, inguinal granuloma, etc.);
• Has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection/AIDS, SCID; Or Autoimmune Diseases (such as systemic lupus erythematosu, Rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious Anemia, Ulcerative colitis, Type 1 diabetes, Graves' disease, hashimoto thyroiditi, etc.);
• History of convulsions, epilepsy, except of febrile convulsions in children 5 years of age and younger;
• History of severe allergy that requires medical intervention, including but not limited to severe adverse reactions caused by vaccine or drug, eg anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia sexual purpura, local allergic necrosis (Arthus reaction), widespread urticaria, dyspnea, angioedema, etc.; History of severe side effect caused by vaccination or severe allergy to any of the components of the investigational vaccine, including histidine, sodium chloride, aluminium phosphate, Polysorbate 80 and water for injection;
• Severe diseases, as determined by the investigator, that affect vaccination eligibility, whether past or current, include severe cardiovascular disease, severe liver and kidney disease, malignant tumor, and serious infectious disease, such as: tuberculosis, viral hepatitis, etc.;
• Before the enrollment, the physical examination was untreatment or uncontrolled hypertension, (18-45 year old: systolic blood pressure ≥140mmHg and / or diastolic blood pressure ≥90mmHg, 9-17 year old: systolic blood pressure ≥120mmHg and / or diastolic blood pressure ≥80mmHg);
• Coagulation disorders: such as Congenital or acquired hemophilia, Coagulation factor deficiency, clotting disorders, thrombocytopenia, etc.;
• No spleen or functional spleen, and no spleen caused by any condition;
• Receive any Immunosuppressive therapy product within 1 month prior to the first vaccination, or plan to receive such product from Day 0 to Month 7 (30 days after receiving the third dose of vaccination)，e.g. systemic medication for glucocorticoid (>20mg/day or 2mg/kg/day, continuous use ≥2 weeks), but local medication can be used (such as ointment, eye drops, inhalants) Or nasal spray);
• Receive any immunoglobulin or blood product within 3 months prior to the first injection, or plan to receive such product from Day 0 to Month 7 (30 days after receiving the third dose of vaccination);
• 3 days before vaccination, suffering from acute illness or acute exacerbation of chronic disease; using fever reducer, Antihistamines, and Analgesics(such as: Acetaminophen, Ibuprofen, loratadine, Cetirizine, etc. )
• Receiving inactivated vaccine or recombinant vaccine or live-attenuated vaccine or nucleic acid vaccine or adenovirus vaccine within 14 days before vaccination;
• History of mental disorders or family history of mental health disorder (immediate family);
• Plan to move out of the city before the end of the study or leave the local area for a long time during the scheduled study visit;
• The investigator believes that the participant has any condition that may interfere with the assessment of the purpose of the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

China · 1 center

• Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention — Nanning

Identifiers

NCT: NCT06756269 · 15-HPV-2001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗