Cervical Cancer, Cervical Intraepithelial Neoplasia, Persistent Infection
Conditions
Keywords
Human Papilloma Virus 16, Human Papilloma Virus 18, Adolescent girl, Long-term Effectiveness, Immuno-persistence
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.
Interventions
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.
OTHERNo intervention
No intervention was implemented.
Sponsors
Xiamen Innovax Biotech Co., Ltd
Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China
Xiamen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 16 and 18 | 8-10 years after the first dose | To evaluate the efficacy of the bivalent vaccine against this outcome |
| Anti-HPV 16 and 18 IgG antibody seropositive rates and geometric mean concentrations | 9 years after the first dose | To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level 9 years after the first dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 31/33/45 | 8-10 years after the first dose | To evaluate the efficacy of the bivalent vaccine against this outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of persistent infections, transient infections, and CIN1+ lesions associated with other high-risk types (except HPV types 16, 18, 31, 33, and 45). | 8-10 years after the first dose | To investigate the potential for type replacement/competition phenomena post-vaccination |
| Incidence of transient and persistent infections with oral HPV | 8-10 years after the first dose | To explore the incidence of transient and persistent oral HPV infections in vaccinated and unvaccinated populations |
Countries
China
Outcome results
None listed