NCT04969445

Brief Summary

The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
647

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2.3 years

First QC Date

July 13, 2021

Last Update Submit

January 24, 2023

Conditions

Cervical Intraepithelial NeoplasiaCervical CancerVaginal Intraepithelial NeoplasiaVulvar Intraepithelial NeoplasiaPersistent Infection

Keywords

Durability of ProtectionHuman Papillomavirus 16Human Papillomavirus 18vaccinefemales

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1

    To observe the number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1

    expected 2-3 years

  • Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1

    To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects

    expected 2-3 years

Study Arms (2)

Vaccine group

Participants in this arm have received 3 doses of HPV 16/18 bivalent vaccine that contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant.

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

Control group

Participants in this arm have received 3 doses of HEV vaccine that contains 30μg HEV virus-like particle antigen adsorbed in alum-adjuvant.

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

Also known as: There is no other Intervention in this study
Vaccine group

Eligibility Criteria

Age26 Years - 54 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

In Hebei Province, participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose

You may qualify if:

  • Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose;
  • Participants can fully understand the study content and sign an informed consent form；
  • Able to comply with the requests of the study;

You may not qualify if:

  • Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study.
  • According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical NeoplasmsPersistent Infection

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Ting Wu, Ph. D.

    Xiamen University

    STUDY CHAIR

Central Study Contacts

Chao Zhao, Doctor

CONTACT

+86-010-88324354zhaochaocjr@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 20, 2021

Study Start

March 30, 2021

Primary Completion

July 27, 2023

Study Completion

January 1, 2024

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

CN(1)