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

Cervical Cancer Clinical Trial

Official title:

Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Girls Aged 9-17 Years

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243666
• Other study ID #: HPV-PRO-006-4
• Status: Not yet recruiting
• Start date: February 20, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Xiamen University
• Contact: Ting Wu, Ph. D.
• Phone: 0592-2880621
• Email: wuting[@]xmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2188
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Persistent Infection
• Uterine Cervical Dysplasia

Intervention

Biological:
• Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
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.

Other:
• No intervention
No intervention was implemented.

Biological:
• Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
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.

Locations

Country	Name	City	State
China	Sheyang County Center for Disease Control and Prevention	Yancheng	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Xiamen University	Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China, Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of persistent infections, transient infections, and CIN1+ lesions associated with other high-risk types (except HPV types 16, 18, 31, 33, and 45).	To investigate the potential for type replacement/competition phenomena post-vaccination	8-10 years after the first dose
Other	Incidence of transient and persistent infections with oral HPV	To explore the incidence of transient and persistent oral HPV infections in vaccinated and unvaccinated populations	8-10 years after the first dose
Primary	Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 16 and 18	To evaluate the efficacy of the bivalent vaccine against this outcome	8-10 years after the first dose
Primary	Anti-HPV 16 and 18 IgG antibody seropositive rates and geometric mean concentrations	To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level 9 years after the first dose	9 years after the first dose
Secondary	Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 31/33/45	To evaluate the efficacy of the bivalent vaccine against this outcome	8-10 years after the first dose