Know Cancer

or
forgot password

Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, When Formulated With Aluminum Hydroxide, AS04, or Without Adjuvant, in Healthy Adult Female Volunteers


Phase 2
18 Years
30 Years
Not Enrolling
Female
Prophylaxis HPV-16/18 Infections and Cervical Neoplasia

Thank you

Trial Information

Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, When Formulated With Aluminum Hydroxide, AS04, or Without Adjuvant, in Healthy Adult Female Volunteers


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Solicited adverse event rates (including injection site and systemic reactions)

Outcome Time Frame:

For 7 days after each injection

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

580299/004

NCT ID:

NCT00693615

Start Date:

October 2000

Completion Date:

January 2005

Related Keywords:

  • Prophylaxis HPV-16/18 Infections and Cervical Neoplasia
  • HPV, Vaccine
  • Neoplasms

Name

Location

GSK Clinical Trials Call CenterHoover, Alabama  35216
GSK Clinical Trials Call CenterNew Orleans, Louisiana  70112
GSK Clinical Trials Call CenterAlbany, New York  12208
GSK Clinical Trials Call CenterCleveland, Ohio  44106-5065
GSK Clinical Trials Call CenterFort Worth, Texas  76104
GSK Clinical Trials Call CenterSalt Lake City, Utah  84109