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

NCT06243666 | Active Not Recruiting

• 1 other identifier: HPV-PRO-006-4
• Study Type: observational
• Target: 2,188
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer; Persistent Infection

Keywords

Human Papilloma Virus 16; Human Papilloma Virus 18; Adolescent girl; Long-term Effectiveness; Immuno-persistence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• 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

• Incidence of transient and persistent infections with oral HPV

  8-10 years after the first dose

Study Arms (3)

Vaccine group for long-term effectiveness evaluation

No intervention was implemented in this study. Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and were aged 9-17 years at the time of enrollment, and have received at least one dose of the vaccine were recruited as the vaccine group for long-term effectiveness evaluation.

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

Control group for long-term effectiveness evaluation

No intervention was implemented in this study. Participants with no previous HPV vaccination history were recruited as the control group for long-term effectiveness evaluation.

Other: No intervention

Vaccine group for immuno-persistence evaluation

No intervention was implemented in this study. Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and were aged 9-26 years at the time of enrollment, and have received at least one dose of the vaccine were recruited as the vaccine group for immuno-persistence evaluation.

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

Interventions

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) BIOLOGICAL

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.

Vaccine group for long-term effectiveness evaluation

No intervention OTHER

No intervention was implemented.

Control group for long-term effectiveness evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiamen University: lead
• Xiamen Innovax Biotech Co., Ltd: collaborator
• Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China: collaborator

Study Sites (1)

Sheyang County Center for Disease Control and Prevention

Yancheng, Jiangsu, China

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms; Persistent Infection

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Ting Wu, Ph. D.

  Xiamen University

  PRINCIPAL INVESTIGATOR

• Jun Zhang, MSc

  Xiamen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CN (1)