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A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects

Phase 1
18 Years
Open (Enrolling)
Cervical Intraepithelial Neoplasia

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Trial Information

A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects

Approximately 600 million people worldwide are infected with the Human Papilloma Virus. In
the majority of cases people can clear the virus on their own however in cases where the
infection is not recognized or is left untreated, the result can be cervical cancer.

This study will examine the safety and tolerability of Hsp-E7 and Poly-ICLC administered
together as a vaccine for Cervical Intraepithelial neoplasia (CIN). There will be 4 cohorts
of subjects in the study each given a higher dose than the one prior providing that prior
dose has been well tolerated and deemed to be safe.

Subjects will be immunized every 28 days for a period of 8 weeks (3 administrations).

Posttreatment evaluation will occur 4 weeks after the last of 3 injections. Subjects with
CIN 2 or 3 disease at the time of enrollment will be eligible to undergo clinically
appropriate therapeutic treatment of the cervix at the twelfth of the study.

Inclusion Criteria:

1. Histologically documented Cervical Intraepithelial Neoplasia 1, 2 or 3.

2. Nonpregnant, Nonlactating female greater than or equal to 18 years of age, who is
either surgically sterile, postmenopausal (no menses for the previous 12 months), or
practices an effective method of birth control (to be continued throughout the study
period) as determined by the Investigator (eg: oral contraceptives, injectables or
implants, intrauterine device, double-barrier methods). The use of cervical cap or
diaphram is not permitted).

3. Geographically accessible for ongoing follow up and committed to comply with all

4. Judged to be in good health based upon the results of a medical history, physical
examination, vital signs and laboratory profile.

5. Capable of understanding and complying with the protocol and has signed the informed

6. Negative for human immunodeficiency virus (HIV)-1, HIV-2, Hepatitis B surface
antigen, and hepatitis C Virus.

Exclusion Criteria:

Prior to Therapy:

1. Prior exposure to HspE7.

2. The subject received immunotherapy (eg, interferons, tumor necrosis factor,
interleukins, or biological response modifiers [GM CSF, G CSF, M CSF]) within 4 weeks
(28 days) prior to study entry.

3. Taken within 7 days or is currently taking selective Cox-2 inhibitors and other
nonsteroidal anti-inflammatory drugs.

4. Received investigational systemic drugs within 4 weeks (28 days) prior to study

5. Undergoing active treatment of genital warts.

6. Has taken astemizole within 7 days prior to study drug administration.

Disease Status:

1. Has an autoimmune disease that in the opinion of the investigator would compromise
the safety of the subject in this study. Some examples of autoimmune disease that may
be considered exclusionary include rheumatoid arthritis, systematic lupus
erythematosus, and autoimmune thyroiditis.

2. Has a recognized immunodeficiency disease, including cellular immunodeficiencies,
hypogammaglobulinemia, or dysgammaglobulinemia. The subject has hereditary or
congenital immunodeficiencies.

3. Has a positive endocervical curettage at the time of biopsy.

Physiological Functions:

1. Has clinically significant hepatic dysfunction (ie, alanine aminotransferase,
aspartate aminotransferase, or total bilirubin ≥1.5 x upper limit of normal (ULN).

2. Has clinically significant renal dysfunction (ie, serum creatinine ≥1.5 x ULN).

3. Has clinically significant cardiac disease, eg, New York Heart Association classes
III IV, uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, or
myocardial infarction in the previous 6 months as confirmed by an electrocardiogram.

4. Has had a splenectomy.

5. Has an infectious process that in the opinion of the investigator would compromise
the subject's ability to mount an immune response.

6. Has a history of severe allergic reaction to insect bites or stings, or to any
biologic pharmaceutical product, including compounds similar to the test article.

7. Has donated or lost a significant volume of blood or plasma (greater than 450 mL)
within 30 days of the study.

Standard Safety:

1. Is pregnant or breast-feeding, or a woman of childbearing potential unless using
effective contraception as determined by the investigator. Subjects whom the
investigator considers may be at risk of pregnancy will have a pregnancy test
performed per institutional standard.

2. Any other reason that, in the opinion of the investigator, precludes the subject from
participating in the study.

3. Known hypersensitivity reaction to any of the components of study treatments.

4. Known alcohol or drug abuse, as assessed by the investigator.

5. Legal incapacity or limited legal capacity.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia

Outcome Time Frame:

4 Weeks after the last of 3 Injections

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

June 2008

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Multicenter
  • Open-Label
  • Nonrandomized
  • Safety
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ



Baylor College of Medicine Houston, Texas  77030
Montefiore Medical Center Bronx, New York  10467-2490
Medical College of Georgia Augusta, Georgia  30912
University of Southern California Los Angeles, California  90033
Medical Center for Clinical Research San Diego, California  92108
University of Oklahoma Health Sciences Center (OUHSC) / OU Medical Center Oklahoma City, Oklahoma  73104
Mt Timpanagos Women's Health Center Pleasant Grove, Utah  84062
Salt Lake Women's Center S. Salt Lake, Utah  84070