Trial Outcomes & Findings for Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia (NCT NCT00121173)
NCT ID: NCT00121173
Last Updated: 2018-07-20
Results Overview
Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
for the duration of the study, and whenever possible, for an additional 5 years
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
Low Dose
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
9
|
|
Overall Study
COMPLETED
|
3
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Baseline characteristics by cohort
| Measure |
Low Dose
n=3 Participants
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
n=3 Participants
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
n=9 Participants
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
26 years
n=5 Participants
|
29 years
n=7 Participants
|
30.3 years
n=5 Participants
|
28.4 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: for the duration of the study, and whenever possible, for an additional 5 yearsPopulation: per protocol
Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.
Outcome measures
| Measure |
Low Dose
n=3 Participants
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
n=3 Participants
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
n=9 Participants
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
|---|---|---|---|
|
Safety and Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: for the duration of the study, and whenever possible, for an additional 5 yearsPopulation: per protocol
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.
Outcome measures
| Measure |
Low Dose
n=3 Participants
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
n=3 Participants
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
n=9 Participants
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
|---|---|---|---|
|
Efficacy
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 15 weeksPopulation: per protocol; participants who had no CIN3 lesions assessed by colposcopy and biopsy(ies) at the week 15 visit
Number of participants with absence of CIN3 lesions at week 15
Outcome measures
| Measure |
Low Dose
n=3 Participants
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
n=3 Participants
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
n=9 Participants
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
|---|---|---|---|
|
Regression of CIN3 Lesions
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 41 weeksPopulation: all patients who completed all 3 vaccinations
Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot)
Outcome measures
| Measure |
Low Dose
n=3 Participants
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
n=3 Participants
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
n=9 Participants
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
|---|---|---|---|
|
Number of Participants With T-cell Immune Responses in the Blood
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: All participants who received all 3 vaccinations
Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV
Outcome measures
| Measure |
Low Dose
n=3 Participants
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
n=3 Participants
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
n=9 Participants
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
|---|---|---|---|
|
Number of Participants With Correlated Measures of Immune Response With Clinical Response
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 9 monthsNumber of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model
Outcome measures
| Measure |
Low Dose
n=3 Participants
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
n=3 Participants
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
n=9 Participants
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
|---|---|---|---|
|
Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Low Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Intermediate Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose
n=3 participants at risk
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
Intermediate Dose
n=3 participants at risk
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
High Dose
n=9 participants at risk
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
|
|---|---|---|---|
|
General disorders
Fatigue/tiredness, flu-like symptoms
|
66.7%
2/3 • Number of events 2 • 19 weeks
|
33.3%
1/3 • Number of events 1 • 19 weeks
|
22.2%
2/9 • Number of events 3 • 19 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 19 weeks
|
0.00%
0/3 • 19 weeks
|
11.1%
1/9 • Number of events 1 • 19 weeks
|
|
General disorders
Injection site reaction
|
100.0%
3/3 • Number of events 4 • 19 weeks
|
0.00%
0/3 • 19 weeks
|
11.1%
1/9 • Number of events 1 • 19 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • 19 weeks
|
0.00%
0/3 • 19 weeks
|
11.1%
1/9 • Number of events 1 • 19 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • 19 weeks
|
33.3%
1/3 • Number of events 1 • 19 weeks
|
0.00%
0/9 • 19 weeks
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • 19 weeks
|
0.00%
0/3 • 19 weeks
|
11.1%
1/9 • Number of events 1 • 19 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 19 weeks
|
33.3%
1/3 • Number of events 1 • 19 weeks
|
0.00%
0/9 • 19 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place