Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Immunogenicity Study of a 2-dose Immunization Schedule of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Adolescent Females Aged 9 to 14 Years
Verified date | April 2023 |
Source | Shanghai Zerun Biotechnology Co.,Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.
Status | Completed |
Enrollment | 900 |
Est. completion date | July 2019 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 9 Years to 24 Years |
Eligibility | Inclusion Criteria: Adult group: - 18-26 healthy female - enable to provide an legal identification - have the ability to understand and sign the Informed Consent Form - aren't pregnant and do not have pregnancy plan within the 7 months after the first injection - used effective contraceptive method from the last menstruation, and agreed to avoid sexual activity without effective contraceptive method within the 15 days after injection Adolescent group: - 9-14 healthy female - enable to provide an legal identification - guardians have the ability to understand the Informed Consent Form, and both participant and guardian agreed to sign the Form (in case of unable to sign, the participant can use fingerprint as signature) Exclusion Criteria: - History of HPV infection - Previous administration of any HPV vaccine - History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock) - History of allergic to vaccine, or to any ingredient of vaccine. - History of epilepsy, seizures or convulsions, or family history of mental illness - Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose. - History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant - Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy - Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder - Acute disease or chronic disease acute exacerbation 7 days prior to vaccination - Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days. - Fever or axillary temperature> 37.0 °C before vaccination - During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month - History of hypertension, physical examination systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mmHg - Abnormal laboratory tests parameters - Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study |
Country | Name | City | State |
---|---|---|---|
China | Hezhou Center for Disease Prevention and Control | Hezhou | Guangxi |
China | Zhongshan Center for Disease Prevention and Control | Zhongshan | Guangxi |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zerun Biotechnology Co.,Ltd | Guangxi Center for Disease Control and Prevention |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HPV-16 and HPV-18 antibody titers (GMT) | Compare the HPV-16 and HPV-18 specific antibody titers (GMT) between the 2-dose immunization schedule (0, 6 months) in adolescent females aged 9 to 14 years and the 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years. | one month after the final injection | |
Secondary | HPV-16 and HPV-18 antibody titers (GMT) and the seroconversion rate | Compare the immunogenicity between the 2-dose (0, 6 months) and the 3-dose (0, 2, 6 months) immunization schedules in adolescent females aged 9-14 years, on the basis of: 1) antibody titers (GMT) and the seroconversion rate at one month after the final injection, 2) antibody titer persistence and 3) antibody titers at a steady status. | 30 months after the final injection | |
Secondary | Local and systemic adverse events (AEs) | Evaluate all local and systemic adverse events (AEs) occurred within 7 days after each inoculation, at one month and 6 month after the whole immunization | 6 months after the final injection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
Completed |
NCT02907333 -
Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia
|
N/A | |
Recruiting |
NCT02576262 -
HPV Integration Testing for Human Papillomavirus-Positive Women
|
N/A | |
Completed |
NCT01029990 -
Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program
|
Phase 0 | |
Recruiting |
NCT05078528 -
Low-cost Imaging Technology for Global Prevention of Cervical Cancer
|
N/A | |
Recruiting |
NCT05502367 -
A Study of ABI-2280 Vaginal Tablet in Participants With Cervical Intraepithelial Neoplasia
|
Phase 1/Phase 2 | |
Completed |
NCT02494310 -
HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings
|
N/A | |
Active, not recruiting |
NCT03429582 -
Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device
|
N/A | |
Active, not recruiting |
NCT02140021 -
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
|
N/A | |
Not yet recruiting |
NCT05510830 -
Diagnostic Cervical Conization for Persistent Infection or Integration of HPV
|
N/A | |
Completed |
NCT02237326 -
Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women
|
N/A | |
Completed |
NCT00316706 -
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
|
Phase 3 | |
Withdrawn |
NCT03143491 -
Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)
|
Phase 2 | |
Completed |
NCT03293628 -
Comparing Two Techniques of Haemostasis After Cervical Conization
|
Phase 2 | |
Recruiting |
NCT05266898 -
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
|
Phase 4 | |
Completed |
NCT02481414 -
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
|
Phase 2 | |
Completed |
NCT02247999 -
Improving Cervical Cancer Screening Among HIV-Infected Women in India
|
||
Recruiting |
NCT04646954 -
DNA Methylation Testing for the Screening of Uterine Cervical Lesion
|
Phase 3 | |
Recruiting |
NCT04650711 -
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
|
Phase 2 | |
Completed |
NCT01544478 -
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
|
Phase 4 |