A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years

NCT06454175 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 15-HPV-1001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HPV Infection; HPV-Related Carcinoma; Genital Wart; HPV-Related Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Adverse Events

  AE of local and systemic reactions within 30 minutes after each dose

  Up to 30 minutes after any vaccination

• Percentage of Participants With Solicited Adverse Events

  The percentage of participants with one or more solicited AEs was assessed.

  Up to 14 days after any vaccination

• Percentage of Participants With Unsolicited Adverse Events

  The percentage of participants with one or more unsolicited AEs was assessed.

  Up to 30 days after any vaccination

• Percentage of Participants With Serious Adverse Events

  The percentage of participants with one or more SAEs was assessed

  From Day 0 after the first dose of vaccination to 6 months after the thrid dose

• Percentage of Female Participants With Pregnancy Events

  The percentage of participants with Pregnancy Events was assessed

  From Day 0 after the first dose of vaccination to 6 months after the thrid dose

Study Arms (2)

HPV-vaccine group

EXPERIMENTAL

According to the 0, 2, and 6 months immunization schedule, intramuscular injection of the upper arm deltoid muscle, 3 doses of the 15-HPV vaccine

Biological: 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha)

Placebo group

PLACEBO COMPARATOR

According to the 0, 2, and 6 months immunization schedule, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Biological: Placebo

Interventions

Placebo BIOLOGICAL

immunization schedule：Month 0，Month 2，Month 6

Placebo group

15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha) BIOLOGICAL

immunization schedule：Month 0，Month 2，Month 6

HPV-vaccine group

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants aged 9-45；
• Participans 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 (a 9-17 year old participant signs an informed notification);
• Axillary temperature was 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 were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period，had no birth plan within the 30 days after receiving the whole vaccination;
• Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study;
• 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.
• Women who receiving hormone test has a regular menstruation for more than one year

You may not qualify if:

• 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 within 3 months before enrollment, including vaccine or drug;
• Before the first dose is vaccinated, the laboratory test indicators specified in the program are abnormal, except for NCS determined by the clinician;
• History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy;
• 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, lymphoma, leukemia, systemic lupus erythematosu, rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious Anemia, Ulcerative colitis or other autoimmune conditions (such as 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;
• Suffering from 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 olds: systolic blood pressure ≥140mmHg and / or diastolic blood pressure ≥90mmHg, 9-17 year olds: 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);
• days before vaccination, suffering from acute illness or acute exacerbation of chronic disease; using fever reducer, Antihistamines, and Analgesics(such as: Acetaminophen, Ibuprofen, Aspirin, loratadine, Cetirizine, etc. )

Sponsors & Collaborators

• Shanghai Bovax Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Guangxi, China

Location

MeSH Terms

Conditions

Papillomavirus Infections; Condylomata Acuminata

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• LIRONG HUANG, Master

  Guangxi Center for Disease Prevention and Crontrol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: August 3, 2024
• Primary Completion: February 5, 2025
• Study Completion: July 5, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)