Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

Trial Title: Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

NCT ID: NCT06243666

Condition: Cervical Intraepithelial Neoplasia
Cervical Cancer
Persistent Infection

Conditions: Official terms:
Persistent Infection
Uterine Cervical Dysplasia
Vaccines

Conditions: Keywords:
Human Papilloma Virus 16
Human Papilloma Virus 18
Adolescent girl
Long-term Effectiveness
Immuno-persistence

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Biological
Intervention name: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
Description: The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant.
Arm group label: Vaccine group for long-term effectiveness evaluation

Intervention type: Other
Intervention name: No intervention
Description: No intervention was implemented.
Arm group label: Control group for long-term effectiveness evaluation

Intervention type: Biological
Intervention name: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
Description: The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant.
Arm group label: Vaccine group for immuno-persistence evaluation

Summary: The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.

Detailed description: This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) . This study proposes to conduct a prospective cohort study based on the cohort population from the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) . By matching control groups according to factors such as age and education level, and through long-term follow-up, this research aims to elucidate the protective efficacy of the bivalent HPV vaccine against future infections of HPV types 16/18/31/33/45 or related diseases in young female populations aged 9-17 years. Additionally, the study will evaluate the persistence of vaccine-induced antibodies, investigate the potential for type replacement/competition phenomena post-vaccination and assess oral HPV infections in the cohort population.

Criteria for eligibility:

Study pop:
Participants who participated in the bridging study (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508) and received at least one dose will be recruited as vaccine group. Participants with no previous HPV vaccination history were recruited as the control group.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Participants must be at least 18 years old; - Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and have received at least one dose of the vaccine (only applicable to the vaccine group); - Able to understand the study procedure and have the ability to comply with the protocol requirements (e.g., collection of biological samples and regular follow-up) and sign a written informed consent form; Exclusion Criteria: - Participants who did not experience sexual debut;* - Participants with acute cervical inflammation and acute lower genital tract infection;* - Participants during menstruation, or have vaginal medication, sexual behavior within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection;* - Participants in the vaccine group have used other HPV vaccine products (including both marketed and unmarketed vaccines) after participating in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508); Participants in the control group have used HPV vaccine products (including both marketed and unmarketed vaccines); - According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the study. - Note: For criteria marked with an asterisk (*), if the participant meets that exclusion criterion, it does not affect the blood sample collection.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Sheyang County Center for Disease Control and Prevention

Address:
City: Yancheng
Country: China

Start date: February 20, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Xiamen University
Agency class: Other

Collaborator:
Agency: Xiamen Innovax Biotech Co., Ltd
Agency class: Industry

Collaborator:
Agency: Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China
Agency class: Other

Source: Xiamen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06243666