SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2013
• Main ID: NCT00091130
• Date of registration: 07/09/2004
• Primary sponsor: National Cancer Institute (NCI)
• Public title: SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
• Scientific title: An Exploratory Study to Evaluate the Effect of HPV 16 Vaccine on the Reduction of Viral Load in HPV 16 Positive Women With Persistent Viral Infection, But Low Grade Disease (ASCUS/LSIL)
• Date of first enrolment: September 2004
• Target sample size: 139
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00091130
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Frank Meyskens
• Affiliation: University of California Medical Center At Irvine-Orange Campus

Key inclusion & exclusion criteria

Inclusion Criteria:

- Meets criteria for 1 of the following groups:

- Prospective group, meeting the following criteria:

- Evidence of atypical squamous cells of undetermined significance (ASCUS) or
low-grade squamous intraepithelial lesions (LSIL) by Pap test

- Human papillomavirus (HPV)-16-positive by polymerase chain reaction (PCR)
and PGMY09/PGMY11 oligonucleotide primers viral load assay

- Medical records-based group, meeting the following criteria:

- Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12
months

- Meets 1 of the following criteria:

- Liquid-cytology findings of ASCUS or LSIL

- Colposcopic evidence of a LSIL by the Reid Index score of 1-5

- Historically persistent HPV-16-infection by PCR and HPV reverse
transcription (RT)-PCR

- No evidence of high-grade squamous intraepithelial lesions (HSIL) by
colposcopy (Reid Index = 6)

- Reports no sex partner change since last index Pap screening test

- Specimen-based group, meeting the following criteria:

- Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12
months

- Liquid-based cytology specimen available

- Meets 1 of the following criteria:

- Liquid-cytology findings of ASCUS or LSIL

- Colposcopic evidence of a LSIL by the Reid Index score of 1-5

- Historically persistent HPV-16-infection by PCR and, where measurable, HPV
RT-PCR showing no greater than 3-fold reduction over the index
liquid-cytology specimen

- No evidence of HSIL by colposcopy (Reid Index = 6)

- Menstrual period occurred at least once within the past 52 weeks

- No HSIL by Pap test within the past year

- Performance status - ECOG 0

- No severe or unstable coagulation

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

- No angina

- No heart failure

- No other cardiac condition

- No respiratory condition

- No asthma

- No immunological disorders (e.g., lupus, diabetes, multiple sclerosis, or myasthenia
gravis)

- Not immunocompromised, suggestive of severe immune deficiency

- HIV negative

- No AIDS

- No active infection, defined as fever > 100° F

- No syphilis

- No severe allergic reactions (anaphylactic response) to drugs or any other allergen

- No history of allergy to any vaccine constituents, including cell- or tissue-system
elements used to prepare the vaccine (e.g., bread products, yeast, or recombinant DNA
technology using yeast systems)

- Must agree to use effective form of contraception throughout vaccination period

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during vaccination period and for 5
months after study treatment

- No sexual intercourse within 48 hours of virus specimen collection during study
visits

- No objects (e.g., tampons, douche, suppositories, fingers, or toes) within the vagina
or rectum within 48 hours of virus specimen collection during study visits

- No prior malignancy except nonmelanoma skin cancer

- No medical or psychiatric illness than would preclude study participation or
compliance

- No other disorders requiring medical intervention that would preclude study
participation

- No prior HPV vaccine

- More than 30 days since prior investigational vaccine

- More than 30 days since prior systemic steroid therapy

- No prior splenectomy

- More than 30 days since prior investigational drug

- More than 72 hours since prior antibiotic therapy for active infection



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Atypical Squamous Cells of Undetermined Significance

Cervical Cancer

High-grade Squamous Intraepithelial Lesion

Low-grade Squamous Intraepithelial Lesion

Intervention(s)

Biological: HspE7

Other: laboratory biomarker analysis

Other: placebo

Primary Outcome(s)

HPV-16 viral load [Time Frame: 6 months]

Natural history of HPV 16 viral load [Time Frame: 3 months]

Natural history of HPV 16 viral load [Time Frame: 6 months]

Natural history of HPV 16 viral load [Time Frame: Baseline]

Regression or non-regression of the cellular atypia [Time Frame: Up to 52 weeks]

Secondary Outcome(s)

HPV-16 viral load [Time Frame: 3 months]

Time to disease resolution [Time Frame: Up to 52 weeks]

Time to infection resolution [Time Frame: Up to 52 weeks]

Secondary ID(s)

CDR0000383786

N01CN25139

NCI-2012-02623

UCI#02-55

Source(s) of Monetary Support

Please refer to primary and secondary sponsors