Active — Not RecruitingPhase 1

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

China72 participantsStarted 2024-08-03

Plain-language summary

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

Who can participate

Age range9 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

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 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;

What they're measuring

Percentage of Participants With Adverse Events

Timeframe: Up to 30 minutes after any vaccination

Percentage of Participants With Solicited Adverse Events

Timeframe: Up to 14 days after any vaccination

Percentage of Participants With Unsolicited Adverse Events

Timeframe: Up to 30 days after any vaccination

Percentage of Participants With Serious Adverse Events

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

Percentage of Female Participants With Pregnancy Events

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

Trial details

NCT IDNCT06454175

SponsorShanghai Bovax Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-05

View on ClinicalTrials.gov More HPV Infection trials

Who can participate

Age range9 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

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 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;

What they're measuring

Percentage of Participants With Adverse Events

Timeframe: Up to 30 minutes after any vaccination

Percentage of Participants With Solicited Adverse Events

Timeframe: Up to 14 days after any vaccination

Percentage of Participants With Unsolicited Adverse Events

Timeframe: Up to 30 days after any vaccination

Percentage of Participants With Serious Adverse Events

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

Percentage of Female Participants With Pregnancy Events

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