Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

NCT00231413 | Completed Phase 2 Results

• 2 other identifiers: 1021152004-003766-14
• Study Type: interventional
• Target: 383
• Locations: 2 countries
• Sites: 11

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.

Conditions

Infections, Papillomavirus

Outcome Measures

Primary Outcomes (4)

• Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 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).

  At Month 7

• Number of Seroconverted Subjects for Anti-HPV-18 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.

  At Month 7

• Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7

  Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.

  At Month 7

• Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7

  Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

  At Month 7

Secondary Outcomes (17)

• Number of Seroconverted Subjects for Anti-HPV-16 at Month 2

  At Month 2

• Number of Seroconverted Subjects for Anti-HPV-18 at Month 2

  At Month 2

• 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

Study Arms (7)

HPV-16/18 Group

ACTIVE COMPARATOR

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.

Biological: HPV 16/18 L1 AS04

HPV-TETRA A Group

EXPERIMENTAL

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.

Biological: HPV-16/18/31/45 L1 AS04 Formulation 1

HPV-TETRA B Group

EXPERIMENTAL

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.

Biological: HPV-16/18/31/45 L1 AS04 Formulation 2

HPV-TETRA C Group

EXPERIMENTAL

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.

Biological: HPV-16/18/31/45 L1 AS04 Formulation 3

HPV-TETRA D Group

EXPERIMENTAL

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.

Biological: HPV-16/18/31/45 L1 AS04 Formulation 4

HPV-TETRA E Group

EXPERIMENTAL

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.

Biological: HPV-16/18/31/45 L1 AS04 Formulation 5

HPV-TETRA F Group

EXPERIMENTAL

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.

Biological: HPV-16/18/31/45 L1 AS04 Formulation 6

Interventions

HPV 16/18 L1 AS04 BIOLOGICAL

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

HPV-16/18 Group

HPV-16/18/31/45 L1 AS04 Formulation 1 BIOLOGICAL

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

HPV-TETRA A Group

HPV-16/18/31/45 L1 AS04 Formulation 2 BIOLOGICAL

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

HPV-TETRA B Group

HPV-16/18/31/45 L1 AS04 Formulation 3 BIOLOGICAL

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

HPV-TETRA C Group

HPV-16/18/31/45 L1 AS04 Formulation 4 BIOLOGICAL

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

HPV-TETRA D Group

HPV-16/18/31/45 L1 AS04 Formulation 5 BIOLOGICAL

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

HPV-TETRA E Group

HPV-16/18/31/45 L1 AS04 Formulation 6 BIOLOGICAL

3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

HPV-TETRA F Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Aurora, Colorado, 80045, United States

Location

GSK Investigational Site

Golden, Colorado, 80401, United States

Location

GSK Investigational Site

Kingston, Rhode Island, 02881, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84109, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84121, United States

Location

GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Roeselare, 8800, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Publications (1)

• Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25.

  PMID: 24674663 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: March 4, 2005
• Primary Completion: March 27, 2006
• Study Completion: March 27, 2006
• Last Updated: December 12, 2019
• Results First Posted: December 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below).
• 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.

Locations

US (5); BE (6)