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Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)

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ClinicalTrials.gov Identifier: NCT00988559
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HPV16 Positive
Cervical Intraepithelial Neoplasia (CIN 2/3)
Interventions: Biological: DNA vaccination
Device: Gene gun vaccine
Biological: intramuscular vaccination
Biological: intra-lesional vaccine administration
Procedure: therapeutic resection of the lesion
Drug: imiquimod

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

132 subjects signed consents to be screened for eligibility

  • 93 subjects signed consents, but did not meet the eligibility criteria to start the study (screen failures)
  • 39 subjects were assigned to a treatment group in the study

Reporting Groups
  Description
PMED Delivery - Groups 1 and 2

Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.

DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)

Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)

therapeutic resection of the lesion: at week 15, all residual lesions will be resected

IM Injections - Groups 5 and 6

Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.

DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)

intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly

therapeutic resection of the lesion: at week 15, all residual lesions will be resected

Intralesional Delivery - Group 3 and 4

Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.

DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)

intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally

therapeutic resection of the lesion: at week 15, all residual lesions will be resected

Intralesional Delivery + Imiquimod - Group 7

Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.

DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)

intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally

therapeutic resection of the lesion: at week 15, all residual lesions will be resected

imiquimod: imiquimod applied to the cervix by the physician


Participant Flow:   Overall Study
    PMED Delivery - Groups 1 and 2   IM Injections - Groups 5 and 6   Intralesional Delivery - Group 3 and 4   Intralesional Delivery + Imiquimod - Group 7
STARTED   10   11   11   7 
COMPLETED   9   9   9   6 
NOT COMPLETED   1   2   2   1 
Withdrawal by Subject                1                1                0                1 
Pregnancy                0                1                1                0 
Lost to Follow-up                0                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants enrolled in the study who received at least one study intervention

Reporting Groups
  Description
PMED Delivery - Groups 1 and 2

Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.

DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)

Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)

therapeutic resection of the lesion: at week 15, all residual lesions will be resected

IM Injections - Groups 5 and 6

Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.

DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)

intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly

therapeutic resection of the lesion: at week 15, all residual lesions will be resected

Intralesional Delivery - Group 3 and 4

Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.

DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)

intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally

therapeutic resection of the lesion: at week 15, all residual lesions will be resected

Intralesional Delivery + Imiquimod - Group 7

Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.

DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)

intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally

therapeutic resection of the lesion: at week 15, all residual lesions will be resected

imiquimod: imiquimod applied to the cervix by the physician

Total Total of all reporting groups

Baseline Measures
   PMED Delivery - Groups 1 and 2   IM Injections - Groups 5 and 6   Intralesional Delivery - Group 3 and 4   Intralesional Delivery + Imiquimod - Group 7   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   11   7   39 
Age 
[Units: Years]
Median (Full Range)
 25.5 
 (20 to 44) 
 26 
 (21 to 35) 
 26 
 (23 to 35) 
 26.14 
 (24 to 29) 
 25.91 
 (20 to 44) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      10 100.0%      11 100.0%      11 100.0%      7 100.0%      39 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1  10.0%      1   9.1%      0   0.0%      0   0.0%      2   5.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      5  45.5%      2  18.2%      4  57.1%      11  28.2% 
White      9  90.0%      5  45.5%      9  81.8%      3  42.9%      26  66.7% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Participants With Related Serious Adverse Events   [ Time Frame: 9 months ]

2.  Secondary:   Absence of CIN2/3 Lesion by Week 15   [ Time Frame: 15 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cornelia L. Trimble, MD
Organization: Johns Hopkins University
phone: 410-502-0512
e-mail: ctrimbl@jhmi.edu



Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00988559     History of Changes
Other Study ID Numbers: J0866
P50CA098252 ( U.S. NIH Grant/Contract )
1R21CA128232 ( U.S. NIH Grant/Contract )
NA_00020850 ( Other Identifier: JHM IRB )
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: October 27, 2016
Results First Posted: July 9, 2018
Last Update Posted: July 9, 2018