A Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 383
- Locations
- 11
- Primary Endpoint
- Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Study Overview
Brief Summary
Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
This study was performed in a double-blinded manner. Blinding was maintained for all subjects and investigators and their study staff participating in this study with regard to the individual subject treatment (vaccine treatment) assignments allocated in this study.
GSK personnel directly involved in the conduct of this study were also blinded to the subjects' treatment assignments.
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A woman between, and including, 18 and 25 years of age at the time of the first vaccination
- •Written informed consent from the subject prior to enrolment
- •Subject must be free of obvious health problems
- •Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners
Exclusion Criteria
- •Pregnant or breastfeeding
- •A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
- •Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
- •History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
- •Previous vaccination against human papillomavirus (HPV)
Arms & Interventions
HPV-16/18 Group
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Intervention: HPV 16/18 L1 AS04 (Biological)
HPV-TETRA A Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Intervention: HPV-16/18/31/45 L1 AS04 Formulation 1 (Biological)
HPV-TETRA B Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Intervention: HPV-16/18/31/45 L1 AS04 Formulation 2 (Biological)
HPV-TETRA C Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Intervention: HPV-16/18/31/45 L1 AS04 Formulation 3 (Biological)
HPV-TETRA D Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Intervention: HPV-16/18/31/45 L1 AS04 Formulation 4 (Biological)
HPV-TETRA E Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Intervention: HPV-16/18/31/45 L1 AS04 Formulation 5 (Biological)
HPV-TETRA F Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
Intervention: HPV-16/18/31/45 L1 AS04 Formulation 6 (Biological)
Outcomes
Primary Outcomes
Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Time Frame: At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
Time Frame: At Month 7
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
Time Frame: At Month 7
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
Time Frame: At Month 7
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Secondary Outcomes
- Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2(At Month 2)
- Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2(At Month 2)
- Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7(At Month 2 and Month 7)
- Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7(At Month 2 and Month 7)
- Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7(At Month 2 and Month 7)
- Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7(At Month 2 and Month 7)
- Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies(From Day 0 to Month 12)
- Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)(From Day 0 up to Month 12)
- Number of Seroconverted Subjects for Anti-HPV-18 at Month 2(At Month 2)
- Number of Seroconverted Subjects for Anti-HPV-16 at Month 2(At Month 2)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7 day post-vaccination period following each dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7 day post-vaccination period following each dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 30-day post-vaccination period)
- Number of Subjects With Any Serious Adverse Events (SAEs)(From Day 0 to Month 7)
- Number of Subjects With Any SAEs During the Extended Safety Follow-up(From Day 0 to Month 12)
- Number of Subjects Reporting Medically Significant Conditions(From Day 0 up to Month 12)
- Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters(At Month 2 and Month 7)