Clinical trial NCT04436133: Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
Official title: A Randomized, Blind, and Positive Control Design to Evaluate the Immunization Efficacy of 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-26 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HPV Infection
HPV-Related Cervical Carcinoma
Lead sponsor: National Vaccine and Serum Institute, China
Sponsor class: INDUSTRY
Collaborators: name: Chengdu Institute of Biological Products Co.,Ltd.
name: Simoon Record Pharma Information Consulting Co., Ltd.
name: Guangxi Center for Disease Control and Prevention
name: Beijing Kantorico Statistical Technology Co., Ltd.
First posted: 2020-06-17
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A total of 480 Chinese women aged 18-26 years old were enrolle，experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6 months immunization program.


Eligibility criteria: Inclusion Criteria:

1. Chinese women aged 18-26 who can provide legal identification;
2. The subject has the ability to understand the research procedure and sign an informed consent;
3. Subjects have the ability to read, understand, fill out diary cards/contact cards and other research application forms and promise to participate in regular follow-up as required by the research;
4. No previous history of HPV vaccination, no participation in HPV vaccine clinical trials, and no plans to receive HPV vaccine during the study period; The subject was not breastfeeding or pregnant (negative urine pregnancy test), did not have a birth plan within 7 months of enrollment; and from day 1 of the last menstrual cycle to day 0 of the study, did not have sex with men or with men Effective contraception was used during sex and no contraceptive failures occurred (examples of contraceptive failure include male condom rupture during sex). And agreed to continue to take effective contraceptive measures within the first 7 months after participating in the study (effective contraceptive measures include: oral contraceptives, hormone patches, intrauterine devices, condoms, cervical caps, etc.).

First dose exclusion criteria:

1. Previous history of cervical lesions (such as abnormal cervical cancer screening, history of CIN disease) or history of hysterectomy surgery (vaginal or total hysterectomy) or history of pelvic radiation therapy; previous history of external genital diseases (such as vulvar epithelium) Neoplasia, intraepithelial neoplasia and genital warts, etc.);
2. Previous history of severe allergic reactions requiring medical intervention for any vaccine or drug (including yeast) (eg: anaphylactic shock, allergic throat edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction) Wait);
3. Immune function is impaired or has been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile Rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
4. Long-term treatment with immunosuppressive agents, such as: long-term (more than 2 weeks in a row) treatment with glucocorticoids (eg, prednisone or similar drugs);
5. Receive any immunoglobulin or blood products within 3 months before vaccination, or plan to receive such products before the 7th month of the study;
6. Received inactivated vaccine or recombinant vaccine within 14 days before vaccination, or received any live vaccine within 28 days;
7. Loss of spleen or functional spleen, and removal of spleen or spleen caused by any situation;
8. Has been diagnosed with a disease that may interfere with the progress or completion of the study, such as: suffering from severe cardiovascular disease (pulmonary heart disease, pulmonary edema), severe liver and kidney disease, diabetes with complications, etc.; or has been diagnosed with Infectious diseases, such as: active tuberculosis, hepatitis B, hepatitis C, etc.;
9. A history of convulsions, epilepsy, encephalopathy, mental illness, family history of mental illness, etc.;
10. There are thrombocytopenia or other coagulation disorders that can be contraindications to intramuscular injection; 11.3 days before the vaccination, suffering from acute disease or in the acute onset of chronic disease or using antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, cetaxidine Tirizine, etc.);

12.Body temperature before inoculation≥37.3℃(armpit body temperature); 13. People who have a systolic blood pressure ≥140mmHg and/or a diastolic blood pressure ≥90mmHg before enrollment; 14. Participate or plan to participate in other clinical trials (drugs, vaccines and medical devices) during the study; 15. Plan to move out of the local area before the end of the study or leave the area for a long time during the scheduled study visit;

Exclusion criteria for second and third doses of vaccination:

1. Before vaccination (the day of vaccination), pregnant or urine pregnancy test (HCG) is positive; Note: If the subject chooses to terminate the pregnancy, at least 6 weeks after the end of pregnancy and the urine pregnancy test is negative on the day before the vaccination, or the medical certificate of termination of pregnancy issued after the end of pregnancy indicates that HCG levels have returned to normal levels, you can continue Vaccination; if you choose to continue pregnancy, you will not be vaccinated for subsequent doses.
2. Newly discovered or newly occurred conditions that meet the first dose exclusion criteria (except Articles 1 and 13);
3. Other serious adverse events: The researcher decides whether to terminate the test vaccination according to his treatment needs;
4. The investigator assessed any other reasons why the vaccination for the trial should be terminated.

Primary outcomes:
measure: Anti-HPV neutralizing antibodies GMT
timeFrame: 30 days after full immunization
measure: Anti-HPV neutralizing antibody positive conversion rate（after full immunization 30 days）
timeFrame: 30 days after full immunization
measure: Collect all SAEs
timeFrame: through study completion, an average of 13 months
measure: Collect AEs incidence
timeFrame: Within 30 minutes of injection
measure: Collect AEs incidence
timeFrame: Within 30 days after inoculation
measure: collect AEs leading subject to withdrawal
timeFrame: through study completion, an average of 13months
measure: collect All pregnancy conditions and pregnancy outcomes
timeFrame: through study completion, an average of 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Liucheng Center for Disease Control and Prevention
state: Guangxi
Study officials:
References: