Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females

NCT ID: NCT00693615

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2005-01-31

Brief Summary

The goals of this study are to describe the safety, reactogenicity and immunogenicity of MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected.

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, comparative trial of three formulations of MEDI-517 given at 0, 30, and 180 days by intramuscular injection. The volunteers in this study will be healthy females 18 through 30 years of age. The study collects safety, reactogenicity and immunogenicity data of MEDI-517 with and without adjuvant. Extended follow-up will provide long-term immune response data.

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

Intervention Type: BIOLOGICAL

IM injection

Group B

Formulation 2 of the vaccine \[with Al(OH)3\]

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

IM injection

Group C

Formulation 3 of the vaccine (without adjuvant)

Group Type: EXPERIMENTAL

MEDI-517 HPV-16/18 VLP vaccine without adjuvant

Intervention Type: BIOLOGICAL

IM injection

Interventions

MEDI-517 HPV-16/18 VLP AS04 vaccine

IM injection

Intervention Type: BIOLOGICAL

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

IM injection

Intervention Type: BIOLOGICAL

MEDI-517 HPV-16/18 VLP vaccine without adjuvant

IM injection

Intervention Type: BIOLOGICAL

Other Intervention Names

MEDI-517 HPV-16/18 VLP AS04 vaccine; MEDI-517 HPV-16/18 VLP vaccine with Al(OH)3

Eligibility Criteria

Inclusion Criteria

• Females 18 through 30 years of age (must not have reached the 31st birthday)
• Written informed consent obtained from the volunteer
• 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
• Must have a negative serum pregnancy test within 21 days of study entry and must not be breast feeding
• 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 physical findings suggestive of other gynaecologic pathogens on pelvic examination within 21 days of study entry
• Agrees to no other vaccines or experimental therapy until 30 days after the last study injection

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
• Use of immunosuppressive medication (inhaled and topical corticosteroids are permitted) 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 blood values at screening. Other 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)
• Genital herpes disease involving the cervix or with disease characterized on examination or by history by extensive external lesions. Volunteers with a history of recurrent genital herpes disease characterized by limited external lesions are eligible to participate in the study.
• 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: Annotated Case Report 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: Statistical Analysis Plan

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: Dataset Specification

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: Informed Consent Form

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

580299/004

Identifier Type: -

Identifier Source: org_study_id