Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06243666

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Cervical Intraepithelial Neoplasia Cervical Cancer Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Infection Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sheyang County Center for Disease Control and Prevention

Yancheng, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

No intervention

Other

No intervention was implemented.

Primary outcomes

  1. Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 16 and 18

    Time frame: 8-10 years after the first dose

    To evaluate the efficacy of the bivalent vaccine against this outcome

  2. Anti-HPV 16 and 18 IgG antibody seropositive rates and geometric mean concentrations

    Time frame: 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 outcomes

  1. Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 31/33/45

    Time frame: 8-10 years after the first dose

    To evaluate the efficacy of the bivalent vaccine against this outcome

Other outcomes

  1. Incidence of persistent infections, transient infections, and CIN1+ lesions associated with other high-risk types (except HPV types 16, 18, 31, 33, and 45).

    Time frame: 8-10 years after the first dose

    To investigate the potential for type replacement/competition phenomena post-vaccination

  2. Incidence of transient and persistent infections with oral HPV

    Time frame: 8-10 years after the first dose

    To explore the incidence of transient and persistent oral HPV infections in vaccinated and unvaccinated populations

Sponsors and collaborators

Lead sponsor

Xiamen University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.