- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00091130
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. Compare the effectiveness of SGN-00101 vaccine vs placebo in reducing the human papillomavirus (HPV)-16 viral load in patients with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) of the cervix with persistent HPV-16 infection who are at increased risk for developing a high-grade squamous intraepithelial lesion or invasive cervical cancer.
II. Compare the natural history of HPV-16 viral load in patients treated with these regimens.
III. Compare the effect of HPV-16 variants on viral load response in patients treated with these regimens.
IV. Compare the relative effectiveness of these regimens on the regression of cervical cellular atypias (based on Pap test results), in terms of the regression of cytologic findings of LSIL and ASCUS to normal findings and resolution or regression of colposcopically defined cervicovaginal lesions, in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive SGN-00101 vaccine subcutaneously (SC) on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
ARM II: Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
Patients are followed at 12, 24, and 52 weeks after the last vaccination.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
California
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Orange, California, Forente stater, 92868
- University of California Medical Center At Irvine-Orange Campus
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm I (SGN-00101)
Patients receive SGN-00101 vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
|
Korrelative studier
Given SC
Andre navn:
|
Placebo komparator: Arm II (placebo)
Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
|
Korrelative studier
Given SC
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
HPV-16 viral load
Tidsramme: 6 months
|
Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model.
The univariate logistic regression model for infection resolution is equivalent to a chi-square test.
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6 months
|
Natural history of HPV 16 viral load
Tidsramme: Baseline
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A repeated measures version of the zero-inflated log-normal model will be constructed.
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Baseline
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Natural history of HPV 16 viral load
Tidsramme: 3 months
|
A repeated measures version of the zero-inflated log-normal model will be constructed.
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3 months
|
Natural history of HPV 16 viral load
Tidsramme: 6 months
|
A repeated measures version of the zero-inflated log-normal model will be constructed.
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6 months
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Regression or non-regression of the cellular atypia
Tidsramme: Up to 52 weeks
|
The analysis for this will employ logistic regression models.
A multivariate logistic regression model will be constructed. .
A two group continuity corrected chi squared test with a 0.050 two-sided significance level will be used.
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Up to 52 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
HPV-16 viral load
Tidsramme: 3 months
|
Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model.
The univariate logistic regression model for infection resolution is equivalent to a chi-square test.
|
3 months
|
Time to infection resolution
Tidsramme: Up to 52 weeks
|
Kaplan Meier curves will be constructed.
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Up to 52 weeks
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Time to disease resolution
Tidsramme: Up to 52 weeks
|
Kaplan Meier curves will be constructed.
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Up to 52 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Frank Meyskens, University of California Medical Center At Irvine-Orange Campus
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCI-2012-02623
- UCI#02-55
- N01CN25139 (Annet stipend/finansieringsnummer: US NIH Grant/Contract Award Number)
- CDR0000383786 (Registeridentifikator: PDQ (Physician Data Query))
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