Clinical trial NCT05372016: Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
Official title: A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged16-26 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HPV Infections
Cervical Cancer
Vulvar Cancer
Vaginal Cancer
CIN1
CIN2
CIN3
VaIN1
VaIN2
VaIN3
Genital Wart
VIN 1
VIN 2
VIN 3
AIS
Lead sponsor: Shanghai Bovax Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chongqing Bovax Biopharmaceutical Co., Ltd.
First posted: 2022-05-12
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief summary: The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.


Eligibility criteria: Inclusion Criteria:

(If the "\*" option is not met during screening, the visit can be rescheduled)

1. Chinese women aged 16-26 who can provide legal identification(If the subject is under 18 years old, proof of legal guardian's identity is also required);
2. The subject agreed to participate in the study, and voluntarily signs the informed consent;for subjects aged 16-18 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together； supposed to understand and sign informed consent form together
3. Subjects are able to understand the study procedures and participate in follow-up according to the study requirements;
4. When the subjects were enrolled, the urine pregnancy test was negative, they were not in the lactation period and had no family planning within 7 months after enrollment.2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures including the pill or condoms, etc ); 5.4. Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
5. \*body temperature \<37.3# (underarm body temperature)

Exclusion Criteria:

First dose exclusion criteria(If the "\*" option is met during screening, the visit can be rescheduled)

1. Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine;
2. Has a history of cervical diseases, such as cervical screening showing abnormal results including CIN or a history of hysterectomy (vaginal or total abdominal hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal);
3. A history of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
4. Subjects present with immune impairment or have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases. Long-term immunosuppressive therapy, e.g., long-term (more than 2 weeks) treatment with glucocorticoids (e.g., prednisone or similar drugs);
5. Has been diagnosed with a severe congenital malformation or chronic disease such as Down syndrome, heart disease, liver disease, kidney disease, diabetes, etc., which may interfere with the conduct or completion of the study;
6. Participating in other (drug or vaccine) clinical trials prior to enrollment or planning to participate during the study;
7. Has been diagnosed with an infectious disease, such as tuberculosis, viral hepatitis and/or HIV infection;
8. A history or family history of convulsions, epilepsy, encephalopathy and mental illness;
9. Have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
10. Absence of a spleen, functional absence of a spleen, and absence or removal of a spleen in any case;
11. \*Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
12. \*Subjects received inactivated or recombinant vaccines within 14 days prior to study enrollment, or attenuated live vaccines within 28 days prior to study enrollment;
13. Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination;
14. \* after questioning, subjects had fever symptoms (subaxillary body temperature ≥37.3#) before the first day of vaccination (within 24 hours before vaccination);
15. Blood pressure on physical examination before the first dose of vaccination was higher than normal or increased (for subjects aged 16-17 year，systolic blood pressure ≥120mmHgand/or diastolic blood pressure ≥80mmHg，for subjects aged 18 year and above，systolic blood pressure ≥140mmHgand/or diastolic blood pressure ≥90mmHg);
16. Subjects may be unable to comply with the study procedure, comply with the agreement, or plan to permanently relocate from the region prior to completion of the study, or may be permanently absent from the region during the scheduled visit;
17. In the opinion of the investigators, the subjects had any other factors that made them unsuitable to participate in the clinical trial.

Primary outcomes:
measure: The seroconversion rate of neutralizing antibodies
timeFrame: 30 days after the last dose
Secondary outcomes:
measure: Number of subjects with postive antibodies after the whole schedule vaccination from the former negative subjects
timeFrame: 30 days after the last dose
measure: The level of neutralizing antibody elicited by the vaccine among the subjects with pre-immune positive after the whole schedule vaccination
timeFrame: 30 days after the last dose
measure: Number of subjects with seroconversion rate (4-fold increase) after the whole schedule vaccination
timeFrame: 30 days after the last dose
measure: Number of AE within 30 minutes after each dose
timeFrame: 30 mins after each dose
measure: Number of SAE within 7days after each dose
timeFrame: day 0 to day 7 after each dose
measure: Number of unsolicited adverse events within 30days after each dose
timeFrame: day 0 to day 30 after each dose
measure: Number of all SAE during the study period
timeFrame: Day 0 to 6 months post vaccination 3
measure: Number and rate of pregnancy events
timeFrame: Day 0 to 6 months post vaccination 3
Other outcomes:
Locations:
city: Guangxi
country: China
facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Study officials:
References: