A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study

Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects From the HPV-058 Study

The purpose of this study is to evaluate the persistence of immune response in subjects who received the HPV-16/18 vaccine, seven to eight years after the last dose of primary vaccination in the HPV-058 study. No new subjects will be enrolled in this extension study.

Study Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Procedure: Blood sampling for antibody determination

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Taizhou, Jiangsu, China, 225300
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subjects/subject's parents/legally acceptable representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject or subject's parents/LAR(s) prior to performing any study specific procedure.
• Written informed assent obtained from the subjects below the legal age of consent.
• Subjects who received all three doses of the HPV-16/18 vaccine in the HPV-058 study.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine which may have an impact on the study objectives) during the period starting 30 days (Day 29 to Day 1) before the study visit.
• Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
• Previous vaccination against HPV outside the HPV-058 study.
• Subjects with contraindications related to blood draw such as blood disorders and anticoagulants use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV Group; Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study.	Procedure: Blood sampling for antibody determination; In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (~5 mL) will be taken from all the subjects, at Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study	A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL).	At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) Study	A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.	At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
Anti-HPV-16 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study	Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.	At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
Anti-HPV-18 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study	Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.	At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies	A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 38, Row "≥19 EL.U/mL, sero-, [Month 72]" and Row "≥19 EL.U/mL, sero+, [Month 72]").	At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies	A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 39, Row "≥ 18 EL.U/mL, sero- [Month 72]" and Row "≥ 18 EL.U/mL, sero+ [Month 72]).	At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
Concentration of Antibodies Against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies	Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-16 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-16 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-16, sero-, [Month 72]" and Row "HPV-16, sero+, [Month 72]").	At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
Concentration of Antibodies Against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies	Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-18 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-18 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-18, sero-, [Month 72]" and Row "HPV-18, sero+, [Month 72]").	At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Hu Y, Zhang X, He Y, Ma Z, Xie Y, Lu X, Xu Y, Zhang Y, Jiang Y, Xiao H, Struyf F, Folschweiller N, Jiang J, Poncelet S, Karkada N, Jastorff A, Borys D. Long-term persistence of immune response to the AS04-adjuvanted HPV-16/18 vaccine in Chinese girls aged 9-17 years: Results from an 8-9-year follow-up phase III open-label study. Asia Pac J Clin Oncol. 2020 Dec;16(6):392-399. doi: 10.1111/ajco.13398. Epub 2020 Aug 11.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): June 29, 2018
• Study Completion (Actual): June 29, 2018

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Chinese; Human papillomavirus; Cervarix; Immune response; Persistence
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 207347; 2017-000255-50 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD for this study is available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No