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Cervical Dysplasia Research

We are interested in how immune responses occur in the cervix.  The focus of our translational research is on developing immune therapies for disease caused by human papillomavirus (HPV).  HPV infection causes more cancers than any other virus in the world.  Cervical cancer is the most common cancer caused by HPV, and although we have known how to screen for it for over half a century, it remains the second most common cause of cancer death in women.  Although the preventive vaccines are a public health milestone, they prevent HPV infections, but are not designed to make immune responses to treat HPV.  We are testing different strategies to make immune responses that could treat HPV disease.

 Read more on the development of therapeutic HPV vaccines in Johns Hopkins Medicine magazine.

Scientific Advances

2001 -- Johns Hopkins establishes a Cervical Diseases Center to offer pap smears and screening for HPV infection in the community and among female admissions to Johns Hopkins Hospital.

2004 – Johns Hopkins investigators begin Phase I clinical trials of a unique therapeutic cervical cancer vaccine aimed at curing established disease. The vaccine works by prompting immune cells to recognize and attack HPV; without the virus, cervical cancer cells can’t survive. It is a landmark study because a third of the participants are minorities, more than double the national average.

2005 – Johns Hopkins researchers publish a study explaining why cervical precancers disappear in some women but not in others. Their report, in Clinical Cancer Research, shows the reason many lesions persist is an unlikely mix of human papillomavirus (HPV) strain and a woman’s individual immune system. Precancerous lesions were three times less likely to resolve without treatment if patients carried the immune system gene HLA*A201 and did not have HPV16, the most common strain of the virus.

2009 – Investigators publish their findings from the first DNA vaccine trial for HPV disease in Clinical Cancer Research.

2009 – Investigators begin a phase II trial of the DNA vaccine boosted with a Vaccinia vector (TA-HPV).

2010 – Investigators begin a pilot at Johns Hopkins study to compare different routes of administration of a DNA vaccine targeting high grade intraepithelial neoplasia (CIN2/3) caused by HPV16.

2011 – In collaboration with investigators at the University of Alabama, the pilot study opens at the University of Alabama at Birmingham.

2014 – Investigators publish their findings of the first part of the phase II trial in Science Translational Medicine.

2014 – Investigators open a new trial using Artesunate vaginal suppositories for the treatment of high grade cervical intraepithelial neoplasia (CIN2/3) caused by HPV.  This study is not strain-specific. 

2015 – The Artensunate Story was featured on NPR.

 


Clinical Trials

A Phase I efficacy and safety study of HPV16-specific therapeutic DNA-vaccinia vaccination in combination with topical imiquimod, in patients with HPV16+ high grade cervical dysplasia (CIN2/3) – (Currently enrolling patients)

OVERVIEW 

This study will test a sequence of two different vaccines (one DNA-based, and one vaccinia-based) with or without topical imiquimod at the site of the lesion. 
   
Subjects in the first three treatment groups will get vaccinated with experimental vaccines, pNGVL4a-sig/E7(detox)/HSP70, and TA-HPV, before having a cone or LEEP procedure at week 15.  Subjects in treatment group 4 will get imiquimod, which is a cream for enhancing immune responses, applied directly to the lesion, before having a cone or a LEEP procedure at week 15.  Subjects in treatment group 5 will get vaccinated and also have the cream on their cervix, before having a cone or a LEEP procedure at week 15.  There are study specific blood samples and cervical swabs collected before and after vaccination, and at the time of surgery.  The vaccines and the cream are provided free of charge to patients in this trial.

ELIGIBILITY 

  • Females over age 18 with HPV16+ CIN2/3
  • Immune competent
  • Informed consent
  • Not pregnant or breastfeeding
  • Not in close social contact with children under 5 or pregnant women if in    the vaccine groups

CONTACT  
Mihaela Paradis – 410-502-0512 or   mparadis@jhmi.edu

 

A Pilot Study of pNGVL4a-CRT-E7(detox) for the Treatment of Patients with HPV16+ Cervical Intraepithelial Neoplasia 3 (CIN3) - (Currently enrolling patients)

OVERVIEW 
This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device.  Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly.  Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.


ELIGIBILITY

  • Females over age 18 with HPV16+ CIN3
  • Immune competent
  • Not allergic to gold
  • Informed consent

CONTACT 
Mihaela Paradis – 410-502-0512 or   mparadis@jhmi.edu

 

A Phase I Study of Intravaginally Administered Artesunate in Women with High Grade Cervical Intraepithelial Neoplasia (CIN2/3) - (Currently enrolling patients)

 
OVERVIEW
This study will test the efficacy and safety of Artesunate vaginal suppositories for the treatment of cervical dysplasia (CIN2/3).  Artesunate has been used by the World Health Organization (WHO) for the treatment of malaria for many years.  Subjects will receive Artesunate suppositories before having a cone or LEEP procedure at week 15 (if an excision is still necessary). There are study specific blood samples and cervical swabs collected before and after receiving the suppositories and at the time of surgery.  The suppositories are provided at no cost to you.

The Artensunate Story was featured on NPR  in January 2015. 

 
ELIGIBILITY

  • Adult women with CIN2/3
  • HPV-positive
  • Informed consent
  • Not pregnant or breastfeeding

CONTACT
Mihaela Paradis – 410-502-0512, mparadis@jhmi.edu

 

An Observational Study to evaluate Tissue and Peripheral Immune Responses in Women with HPV16+ Cervical Intraepithelial Neoplasia - (Currently enrolling patients)

OVERVIEW

                This study is a brief15-week observational protocol prior to standard resection of dysplastic lesions.  We obtain cervical swabs, and draw a small amount of blood from your arm at study visits.  At week 15, patients undergo a cervical LEEP or cone, to remove any residual abnormal tissue.  The LEEP or cone are both standard therapies for high grade dysplasia.  Over 300 women have participated in this study to date.  No lesions have gotten more severe in the 15-week study window.  In fact, we have found that 25% of lesions associated with HPV16 undergo regression in the study window. This study is helping us to determine immune responses in the cervix, and immune responses in the blood.

ELIGIBILITY

  • Adult women over age 18 with cervical dysplasia
  • Immune competent
  • Informed consent

CONTACT

Mihaela Paradis – 410-502-0512, or mparadis@jhmi.edu

 


 

 

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