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A Phase I Clinical Trial of an HPV Therapeutic Vaccine


Phase 1
18 Years
50 Years
Open (Enrolling)
Female
Human Papillomavirus

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Trial Information

A Phase I Clinical Trial of an HPV Therapeutic Vaccine


Inclusion Criteria:



- Aged 18-50 years

- Had recent Pap smear result consistent with HSIL or "cannot rule out HSIL" or HSIL on
biopsy

- Untreated for HSIL or "Cannot rule out HSIL"

- Able to provide informed consent

- Certain physical exam and blood component parameters within acceptable ranges

- Willingness and able to comply with the requirements of the protocol with a good
command of the English language

Exclusion Criteria:

- History of disease or treatment causing immunosuppression (e.g., cancer, HIV, organ
transplant, autoimmune disease)

- Being pregnant or attempting to be pregnant within the period of enrollment

- Breast feeding or planning to breast feed within the period of enrollment

- Allergy to Candida antigen

- History of severe asthma requiring emergency room visit or hospitalization

- Current use of beta-blocker medication (may not respond to epinephrine in case of
anaphylaxis)

- If in the opinion of the Principal Investigator or other Investigators, it is not in
the best interest of the patient to enter this study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

safety

Outcome Description:

real-time safety measurement of the combined administration of HPV vaccine and CandinĀ® as measured by dose limiting toxicity as defined by adverse events; safety will be assessed at time of vaccination, 30 minutes post-injection, and daily for 7 days post injections.

Outcome Time Frame:

immediately then up to 7 days post vaccinations

Safety Issue:

Yes

Principal Investigator

Mayumi Nakagawa, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Food and Drug Administration

Study ID:

130662

NCT ID:

NCT01653249

Start Date:

August 2012

Completion Date:

October 2014

Related Keywords:

  • Human Papillomavirus
  • human papillomavirus (HPV)
  • vaccine
  • treatment

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205