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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 begin Phase II trials of the vaccine


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


HPV003- Phase II placebo-controlled study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA vaccine) delivered IM followed by electroporation (EP) with CELLECTRA®-5P for the treatment of biopsy-proven CIN2/3 or CIN3 with documented HPV16 or 18 (currently enrolling patients)

OVERVIEW 
This study will test the efficacy and safety of VGX-3100 delivered intramuscularly, followed by electroporation in patients with HPV16+ or HPV18+ CIN2/3.  Subjects will receive either placebo or VGX-3100 vaccinations at week 0, 4 and 12, prior to a cone or LEEP resection at week 36.  There are a total of 12 visits over a period of 88 weeks.

ELIGIBILITY 

  • Healthy females age 18-50 with HPV16 or HPV18+ CIN2/3 or CIN3
  • Immune competent
  • Not pregnant or breastfeeding
  • Informed consent

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


An Observational Trial to Evaluate Tissue and Peripheral Immune Responses in Women with HPV-16+ Cervical Intraepithelial Neoplasia – currently enrolling patients

OVERVIEW 
This study is a brief 15-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  

  • Females over age 18 with cervical dysplasia
  • Immune competent
  • Informed consent

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

This study consists of 12 visits over a period of 88 weeks

 

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