Trial Outcomes & Findings for Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3) (NCT NCT00988559)
NCT ID: NCT00988559
Last Updated: 2018-07-09
Results Overview
Presence of intervention-related serious adverse events as defined by CTCAE
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
132 participants
Primary outcome timeframe
9 months
Results posted on
2018-07-09
Participant Flow
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
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
11
|
7
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
Baseline characteristics by cohort
| Measure |
PMED Delivery - Groups 1 and 2
n=10 Participants
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
n=11 Participants
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
n=11 Participants
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
n=7 Participants
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
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.5 years
n=5 Participants
|
26 years
n=7 Participants
|
26 years
n=5 Participants
|
26.14 years
n=4 Participants
|
25.91 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
39 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
26 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: Related Serious Adverse Events
Presence of intervention-related serious adverse events as defined by CTCAE
Outcome measures
| Measure |
PMED Delivery - Groups 1 and 2
n=10 Participants
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
n=11 Participants
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
n=11 Participants
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
n=7 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Related Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 15 weeksPopulation: Number of participants who had no CIN2/3 at the week 15 resection
Number of participants with no CIN2/3 lesion at the week 15 visit
Outcome measures
| Measure |
PMED Delivery - Groups 1 and 2
n=9 Participants
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
n=9 Participants
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
n=9 Participants
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
n=6 Participants
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
|
|---|---|---|---|---|
|
Absence of CIN2/3 Lesion by Week 15
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
PMED Delivery - Groups 1 and 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
IM Injections - Groups 5 and 6
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Intralesional Delivery - Group 3 and 4
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Intralesional Delivery + Imiquimod - Group 7
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PMED Delivery - Groups 1 and 2
n=10 participants at risk
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
n=11 participants at risk
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
n=11 participants at risk
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
n=7 participants at risk
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
|
|---|---|---|---|---|
|
General disorders
Injection site reactions
|
80.0%
8/10 • Number of events 43 • 41 weeks
|
54.5%
6/11 • Number of events 10 • 41 weeks
|
9.1%
1/11 • Number of events 1 • 41 weeks
|
0.00%
0/7 • 41 weeks
|
|
General disorders
General pain, fever, malaise/fatigue
|
80.0%
8/10 • Number of events 44 • 41 weeks
|
72.7%
8/11 • Number of events 38 • 41 weeks
|
72.7%
8/11 • Number of events 41 • 41 weeks
|
100.0%
7/7 • Number of events 37 • 41 weeks
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 2 • 41 weeks
|
0.00%
0/11 • 41 weeks
|
0.00%
0/11 • 41 weeks
|
14.3%
1/7 • Number of events 1 • 41 weeks
|
|
Nervous system disorders
Limb numbness
|
10.0%
1/10 • Number of events 5 • 41 weeks
|
9.1%
1/11 • Number of events 1 • 41 weeks
|
0.00%
0/11 • 41 weeks
|
0.00%
0/7 • 41 weeks
|
|
Infections and infestations
Rash
|
0.00%
0/10 • 41 weeks
|
18.2%
2/11 • Number of events 2 • 41 weeks
|
0.00%
0/11 • 41 weeks
|
14.3%
1/7 • Number of events 1 • 41 weeks
|
|
Reproductive system and breast disorders
Vaginal bleeding/spotting
|
0.00%
0/10 • 41 weeks
|
0.00%
0/11 • 41 weeks
|
27.3%
3/11 • Number of events 3 • 41 weeks
|
14.3%
1/7 • Number of events 6 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/10 • 41 weeks
|
9.1%
1/11 • Number of events 2 • 41 weeks
|
0.00%
0/11 • 41 weeks
|
14.3%
1/7 • Number of events 1 • 41 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place