Clinical trial NCT06243666: Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls
Official title: Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Girls Aged 9-17 Years
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Intraepithelial Neoplasia
Cervical Cancer
Persistent Infection
Keywords: Human Papilloma Virus 16
Human Papilloma Virus 18
Adolescent girl
Long-term Effectiveness
Immuno-persistence
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
name: Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China
First posted: 2024-02-06
Enrollment: 2188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 16 and 18
timeFrame: 8-10 years after the first dose
measure: Anti-HPV 16 and 18 IgG antibody seropositive rates and geometric mean concentrations
timeFrame: 9 years after the first dose
Secondary outcomes:
measure: Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 31/33/45
timeFrame: 8-10 years after the first dose
Other outcomes:
measure: Incidence of persistent infections, transient infections, and CIN1+ lesions associated with other high-risk types (except HPV types 16, 18, 31, 33, and 45).
timeFrame: 8-10 years after the first dose
measure: Incidence of transient and persistent infections with oral HPV
timeFrame: 8-10 years after the first dose
Locations:
city: Yancheng
country: China
facility: Sheyang County Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Xiamen University
name: Ting Wu, Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiamen University
name: Jun Zhang, MSc
role: STUDY_CHAIR
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