Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

Phase 2

Completed

• Conditions: Papillomavirus Vaccines; Infections, Papillomavirus
• Interventions: Biological: HPV investigational vaccine GSK568893A, different formulations; Biological: CervarixTM

• Registration Number: NCT00359619
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-02
• Study Start: 2006-09-12
• Primary Completion: 2007-01-30
• Study Completion: 2007-01-30
• Disposition First Submitted: 2011-02-04
• Disposition First Submitted QC: 2011-02-04
• Disposition First Posted: 2011-02-09
• Results First Submitted: 2012-12-19
• Results First Submitted QC: 2015-01-08
• Results First Posted: 2015-02-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 383

Inclusion Criteria

• A female who enrolled in the study 102115 and received three doses of vaccine.
• Written informed consent obtained from the subject prior to enrolment.

Read More

Exclusion Criteria

• Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
• Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
• Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
• Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervarix 5 Group	HPV investigational vaccine GSK568893A, different formulations	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 4 Group	HPV investigational vaccine GSK568893A, different formulations	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 2 Group	HPV investigational vaccine GSK568893A, different formulations	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 3 Group	HPV investigational vaccine GSK568893A, different formulations	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix Group	CervarixTM	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 1 Group	HPV investigational vaccine GSK568893A, different formulations	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 6 Group	HPV investigational vaccine GSK568893A, different formulations	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	At Months 18, 24, 36 and 48.	Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	At Months 18, 24, 36 and 48.	Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.

Secondary Outcome Measures

Name	Time	Method
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	At Months 18, 24, 36 and 48.	Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Number of Subjects With Pregnancy Outcomes.	From Month 0 to Month 48	Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	At Months 18, 24, 36 and 48.	Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Number of Subjects With Any Serious Adverse Events (SAEs).	From Month 0 to Months 18, 24, 36 and 48	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. Any = Occurrence of any symptom regardless of intensity grade.
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	From Month 0 to Months 18, 24, 36 and 48	NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities \[MedDRA\] Preferred Term)
Number of Subjects With at Least One Medically Significant Condition (MAEs).	From Month 0 to Months 18, 24, 36 and 48	MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Wilrijk, Belgium