Cervical cancer
Conditions
Interventions
Two-dose sequential vaccination group:Individuals with prior 2-valent HPV vaccination will receive 2 sequential 9-valent doses at months 0, and 6.
Primary immunization group:individuals with no history of HPV vaccination will receive three doses of the 9-valent HPV vaccine according to the 0, 1, 6-month schedule
Three-dose sequential vaccination group:Individuals with prior 2-valent HPV vaccination will receive 3 sequential 9-valent doses at months 0, 1, and 6
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female volunteers, aged 18-45 years at the time of receiving the first trial vaccine dose; 2. Volunteers (and their legal guardians) are able to understand the study procedures and are capable of complying with protocol requirements (such as collecting biological samples, filling out diary cards, and attending follow-up visits on schedule), and have signed the informed consent form; 3. Adult female volunteers agree not to plan a pregnancy and to use effective contraception within 8 months after completing the first dose, or are women who have undergone tubal ligation, subtotal hysterectomy for benign lesions, or removal of benign ovarian tumors; For participants in the sequential group, the following additional criteria must be met: 4. Previously completed the full three-dose schedule of XinKeNing, XiRuiShi, and WoZeHui [full three-dose schedule is defined as completing the second and third doses within 12 months after the first dose]; 5. The interval between the last dose of XinKeNing, XiRuiShi, or WoZeHui and the enrollment date is = 12 months.
Exclusion criteria
Exclusion criteria: 1. Axillary temperature > 37.0°C; 2. Positive urine pregnancy test in adult female volunteers, or being currently pregnant or breastfeeding; 3. Use of any other investigational or unregistered product (drug or vaccine) within 30 days prior to study vaccination, or planned use of other investigational or unregistered products or participation in another clinical study during the study period; 4. Long-term (continuous for more than 14 days) use of immunosuppressants or other immunomodulatory medications within 6 months prior to vaccination. Systemic administration of corticosteroid medications is excluded, while topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) is permitted; 5. Use of immunoglobulins and/or blood products within 3 months prior to vaccination, or planned use within 7 months after the first dose, with the exception of emergency post-exposure use of tetanus immunoglobulin and rabies immunoglobulin; 6. Receipt of an inactivated vaccine within 7 days, or a live vaccine within 14 days, prior to study vaccination; 7. Experienced fever (axillary temperature =38.0°C) within 3 days prior to vaccination, or any serious acute illness requiring systemic antibiotic or antiviral therapy within the past 5 days, or taken medication containing antipyretic ingredients within the past 24 hours; 8. Previous vaccination with any HPV vaccine other than Cecolin, Cervarix, or Walvax; 9. Suffering from severe immunodeficiency diseases, severe primary diseases of vital organs, cancer (or precancerous lesions), autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, immunodeficiency caused by asplenia or splenectomy due to any reason, and other autoimmune diseases considered by the investigator to potentially affect the immune response); 10. History of severe allergies, including severe adverse reactions to previous vaccinations such as anaphylactic shock, acute urticaria, dyspnea, angioedema, or allergy to any component of the study vaccine (aluminum adjuvant, polysorbate, sodium dihydrogen phosphate, disodium hydrogen phosphate); 11. Asthma that has been unstable in the past two years, requiring emergency treatment, hospitalization, oral or intravenous corticosteroids; 12. Coagulation abnormalities or bleeding disorders; 13. Epilepsy, excluding febrile seizures under 2 years of age, alcohol-related seizures in the 3 years prior to abstinence, or simple epilepsy that has not required treatment in the past 3 years; 14. Any medical, psychological, social, occupational, or other conditions that, in the judgment of the investigator after reviewing the volunteer's medical history and relevant physical examination, may interfere with the conduct of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions/events within 7 days after each dose of vaccination;;Geometric mean concentrations (GMC) of neutralizing antibody levels against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58;; | — |
Secondary
| Measure | Time frame |
|---|---|
| IgG binding antibody GMC, positivity and seroconversion rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58;Incidence of adverse events within 30 days after each dose of vaccination;;Neutralizing antibody positive and seroconversion rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 ;Incidence of serious adverse events throughout the study period, as well as pregnancy events and outcomes;IgG binding antibody GMC, positivity and seroconversion rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58;Neutralizing antibody GMC, positivity and seroconversion rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58; | — |
Countries
China
Contacts
Public ContactMingwei Wei
Jiangsu Provincial Center for Disease Control and Prevention
Outcome results
None listed