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Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00121173
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
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: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Cervical Cancer
Precancerous Condition
Intervention Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose Intermediate Dose High Dose
Hide Arm/Group Description

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Period Title: Overall Study
Started 4 3 9
Completed 3 3 9
Not Completed 1 0 0
Arm/Group Title Low Dose Intermediate Dose High Dose Total
Hide Arm/Group Description

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Total of all reporting groups
Overall Number of Baseline Participants 3 3 9 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 9 participants 15 participants
<=18 years
1
  33.3%
0
   0.0%
0
   0.0%
1
   6.7%
Between 18 and 65 years
2
  66.7%
3
 100.0%
9
 100.0%
14
  93.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Participants age 18 and older
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 9 participants 15 participants
26
(18 to 36)
29
(20 to 46)
30.3
(20 to 45)
28.4
(18 to 46)
[1]
Measure Description: Participants ages 18 and older
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 9 participants 15 participants
Female
3
 100.0%
3
 100.0%
9
 100.0%
15
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 9 participants 15 participants
Hispanic or Latino
1
  33.3%
1
  33.3%
0
   0.0%
2
  13.3%
Not Hispanic or Latino
2
  66.7%
2
  66.7%
9
 100.0%
13
  86.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 9 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  11.1%
1
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  33.3%
1
  33.3%
1
  11.1%
3
  20.0%
White
1
  33.3%
1
  33.3%
7
  77.8%
9
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  33.3%
1
  33.3%
0
   0.0%
2
  13.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 9 participants 15 participants
3 3 9 15
1.Primary Outcome
Title Safety and Toxicity
Hide Description Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.
Time Frame for the duration of the study, and whenever possible, for an additional 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Low Dose Intermediate Dose High Dose
Hide Arm/Group Description:

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Overall Number of Participants Analyzed 3 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Efficacy
Hide Description The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy.
Time Frame for the duration of the study, and whenever possible, for an additional 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Low Dose Intermediate Dose High Dose
Hide Arm/Group Description:

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Overall Number of Participants Analyzed 3 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3
  33.3%
3.Secondary Outcome
Title Regression of CIN3 Lesions
Hide Description Number of participants with absence of CIN3 lesions at week 15
Time Frame 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol; participants who had no CIN3 lesions assessed by colposcopy and biopsy(ies) at the week 15 visit
Arm/Group Title Low Dose Intermediate Dose High Dose
Hide Arm/Group Description:

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals.

Genetic (recombinant DNA vaccine)

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine: recombinant DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine: recombinant DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine: recombinant DNA vaccine

Overall Number of Participants Analyzed 3 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3
  33.3%
4.Secondary Outcome
Title Number of Participants With T-cell Immune Responses in the Blood
Hide Description Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot)
Time Frame 41 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
all patients who completed all 3 vaccinations
Arm/Group Title Low Dose Intermediate Dose High Dose
Hide Arm/Group Description:

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Overall Number of Participants Analyzed 3 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Correlated Measures of Immune Response With Clinical Response
Hide Description Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received all 3 vaccinations
Arm/Group Title Low Dose Intermediate Dose High Dose
Hide Arm/Group Description:

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Overall Number of Participants Analyzed 3 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model
Hide Description Number of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Intermediate Dose High Dose
Hide Arm/Group Description:

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Overall Number of Participants Analyzed 3 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 19 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Intermediate Dose High Dose
Hide Arm/Group Description

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

All-Cause Mortality
Low Dose Intermediate Dose High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Intermediate Dose High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose Intermediate Dose High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      2/3 (66.67%)      5/9 (55.56%)    
Gastrointestinal disorders       
Diarrhea *  0/3 (0.00%)  0 1/3 (33.33%)  1 0/9 (0.00%)  0
General disorders       
Fatigue/tiredness, flu-like symptoms *  2/3 (66.67%)  2 1/3 (33.33%)  1 2/9 (22.22%)  3
Injection site reaction *  3/3 (100.00%)  4 0/3 (0.00%)  0 1/9 (11.11%)  1
Nervous system disorders       
Headache *  0/3 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1
Reproductive system and breast disorders       
Vaginal discharge *  0/3 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders       
Rash *  1/3 (33.33%)  1 1/3 (33.33%)  1 0/9 (0.00%)  0
Vascular disorders       
Hot flashes *  0/3 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cornelia L. Trimble, MD
Organization: Johns Hopkins University
Phone: 410-502-0512
EMail: ctrimbl@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00121173     History of Changes
Other Study ID Numbers: J0323 CDR0000439494
R21CA105696 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0323
JHOC-03-05-06-02 ( Other Identifier: JHM IRB )
First Submitted: July 19, 2005
First Posted: July 21, 2005
Results First Submitted: March 28, 2014
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018