Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females

NCT ID: NCT00693966

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2004-09-30

Brief Summary

The purpose of this Phase II study is to provide data regarding the safety and immunogenicity for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative for high-risk HPV DNA. The study is designed to evaluate safety and immunogenicity data for MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will provide long-term immune response data.

This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.

Detailed Description

This is a Phase II double-blind, randomized, dose-comparison, multicenter study in the United States of three different dose levels of MEDI-517 (HPV-16/18 VLP AS04 vaccine) and one dose of MEDI-517 formulated with aluminum hydroxide, with doses administered at 0, 30 and 180 days. Healthy female volunteers 18 through 30 years of age will be entered into 4 treatment arms. The objectives of study are to evaluate reactogenicity, safety and immunogenicity.

Conditions

Infections, Papillomavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Formulation 1 of the vaccine (MEDI-517 HPV-16/18 VLP AS04 vaccine)

Group Type: EXPERIMENTAL

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)

Intervention Type: BIOLOGICAL

IM injection

Group B

Formulation 2 of the vaccine

Group Type: EXPERIMENTAL

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)

Intervention Type: BIOLOGICAL

IM injection

Group C

Formulation 3 of the vaccine

Group Type: EXPERIMENTAL

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)

Intervention Type: BIOLOGICAL

IM injection

Group D

Formulation 4 of the vaccine \[with Al(OH)3\]

Group Type: EXPERIMENTAL

MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)

Intervention Type: BIOLOGICAL

IM injection

Interventions

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)

IM injection

Intervention Type: BIOLOGICAL

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)

IM injection

Intervention Type: BIOLOGICAL

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)

IM injection

Intervention Type: BIOLOGICAL

MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)

IM injection

Intervention Type: BIOLOGICAL

Other Intervention Names

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2); MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3); MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)

Eligibility Criteria

Inclusion Criteria

• Females 18 through 30 years of age (must not have reached the 31st birthday)
• Unless previously surgically sterilized, agrees to use an effective method of birth control beginning 30 days before the first study injection and continuing through 60 days after the final study injection
• Healthy by medical history and physical examination
• Seronegative for HPV-16 and HPV-18 antibody by ELISA within 21 days of study entry
• Cervical specimen negative for high-risk HPV DNA using the Digene Hybrid Capture® II HPV test (high-risk types Probe B) within 21 days of study entry
• Normal Pap smear, using the Cytyc ThinPrep® Pap Test, within 21 days of study entry
• No evidence of anogenital HPV lesions or no physical findings suggestive of other gynecologic pathogens on pelvic examination within 21 days of study entry
• Agrees to no other experimental therapy or vaccines until 30 days after the last study injection
• Written informed consent obtained from the volunteer

Exclusion Criteria

• Acute illness or fever (oral temperature ≥ 99.5°F [37.5°C]) at start of the study
• History or clinical manifestations of significant medical or psychiatric disorder
• Pregnant or lactating
• Use of immunosuppressive medication within the previous 90 days or history of immunodeficiency
• History of cancer
• History of alcohol or drug abuse within the past 2 years
• Abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant
• Receipt of immunoglobulin or blood products within 90 days prior to study entry
• History of abnormal Pap smear (other than a single prior report of ASCUS or indeterminate Pap smear with a subsequent normal report)
• Positive tests for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 antibody
• Any prior receipt of any vaccine (experimental or otherwise) for treatment or prophylaxis of genital warts or other papillomavirus related condition. Any treatment of genital warts or other papillomavirus related condition within 6 months of randomization (local therapy for common skin and/or plantar warts is allowed)
• Previous administration of any components of the investigational vaccine
• Receipt of any experimental vaccine within 90 days prior to entry into this study
• Receipt of any experimental drug therapy within 30 days or five half-lives of the experimental drug (if the half-life is known), whichever is longer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.

Reference Type: BACKGROUND

PMID: 19221517 (View on PubMed)

Giannini SL, Hanon E, Moris P, Van Mechelen M, Morel S, Dessy F, Fourneau MA, Colau B, Suzich J, Losonksy G, Martin MT, Dubin G, Wettendorff MA. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only. Vaccine. 2006 Aug 14;24(33-34):5937-49. doi: 10.1016/j.vaccine.2006.06.005. Epub 2006 Jun 19.

Reference Type: BACKGROUND

PMID: 16828940 (View on PubMed)

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

Reference Type: BACKGROUND

PMID: 18845199 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

580299/005

Identifier Type: -

Identifier Source: org_study_id