Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.

Overview

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).

Full Title of Study: “Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 6, 2015

Detailed Description

Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study. Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

Interventions

  • Procedure: Blood sampling
    • Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120

Arms, Groups and Cohorts

  • Other: Cervarix Group
    • Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
    • Time Frame: At Month 60
    • Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
    • Time Frame: At Month 72
    • Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
    • Time Frame: At Month 84
    • Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
    • Time Frame: At Month 96
    • Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
    • Time Frame: At Month 60
    • Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
    • Time Frame: At month 72
    • Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
    • Time Frame: At Month 84
    • Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
    • Time Frame: At Month 96
    • Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
    • Time Frame: At Month 108
    • Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
    • Time Frame: At Month 108
    • Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
    • Time Frame: At Month 120
    • Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
    • Time Frame: At Month 120
    • Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.

Secondary Measures

  • Number of Subjects With Serious Adverse Events (SAEs)
    • Time Frame: From Month 48 to Month 60
    • SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
  • Number of Subjects With Serious Adverse Events (SAEs)
    • Time Frame: From Month 60 to Month 72
    • SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
  • Number of Subjects With Serious Adverse Events (SAEs)
    • Time Frame: From Month 72 to Month 84
    • SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
  • Number of Subjects With Serious Adverse Events (SAEs)
    • Time Frame: From Month 84 to Month 96
    • SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
  • Number of Subjects With Serious Adverse Events (SAEs)
    • Time Frame: From Month 96 to Month 108
    • SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
  • Number of Subjects With Serious Adverse Events (SAEs)
    • Time Frame: From Month 108 to Month 120
    • SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study. – A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013. – Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject. Exclusion Criteria:

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. – Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. – Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013. – Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry. – Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

References

Schwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D. Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial. Pediatr Infect Dis J. 2014 Dec;33(12):1255-61. doi: 10.1097/INF.0000000000000460.

Schwarz TF, Huang LM, Valencia A, Panzer F, Chiu CH, Decreux A, Poncelet S, Karkada N, Folschweiller N, Lin L, Dubin G, Struyf F. A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years. Hum Vaccin Immunother. 2019;15(7-8):1970-1979. doi: 10.1080/21645515.2019.1625644. Epub 2019 Jul 17.

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