Trial Outcomes & Findings for VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (NCT NCT03603808)
NCT ID: NCT03603808
Last Updated: 2026-05-08
Results Overview
Defined as histopathological regression of human papillomavirus (HPV)-16 and/or 18-positive anal high grade squamous intraepithelial neoplasia (HSIL) to low grade squamous intraepithelial neoplasia (LSIL) \[anal intraepithelial neoplasia (AIN)1\] or normal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
At 48 weeks
Results posted on
2026-05-08
Participant Flow
89 HIV-positive participants were screened for HPV-16 or 18 DNA-positivity on anal swabs and presence of at least one biopsy-proven anal HSIL between September 2019 and May 2024.
Participant milestones
| Measure |
Treatment (VGX-3100, Electroporation)
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
Completed Primary Endpoint Assessment
|
37
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (VGX-3100, Electroporation)
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions
Baseline characteristics by cohort
| Measure |
Treatment (VGX-3100, Electroporation)
n=44 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 11.1 • n=41 Participants
|
|
Age, Customized
<40 years
|
9 Participants
n=41 Participants
|
|
Age, Customized
40-55 years
|
20 Participants
n=41 Participants
|
|
Age, Customized
>55 years
|
15 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=41 Participants
|
|
Count of suspicious lesions visualized by high resolution anoscopy
|
4 lesions
n=41 Participants
|
PRIMARY outcome
Timeframe: At 48 weeksPopulation: Patients with available primary endpoint assessment data
Defined as histopathological regression of human papillomavirus (HPV)-16 and/or 18-positive anal high grade squamous intraepithelial neoplasia (HSIL) to low grade squamous intraepithelial neoplasia (LSIL) \[anal intraepithelial neoplasia (AIN)1\] or normal.
Outcome measures
| Measure |
Treatment (VGX-3100, Electroporation)
n=37 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Response Rate at 48 Weeks
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 72 weeksPopulation: Participants who received at least one vaccine VGX-3100
Safety and tolerability of treatment as assessed by incidence of adverse events assessed by Common Toxicity Criteria for Adverse Events version 5 (CTCAE v.5). Toxicity data will be presented by type and severity.
Outcome measures
| Measure |
Treatment (VGX-3100, Electroporation)
n=43 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Safety and Tolerability of Treatment as Assessed by Incidence of Adverse Events
Number of participants with any adverse events
|
30 Participants
|
|
Safety and Tolerability of Treatment as Assessed by Incidence of Adverse Events
Number of participants with any treatment-related adverse event
|
22 Participants
|
|
Safety and Tolerability of Treatment as Assessed by Incidence of Adverse Events
Number of participants with any serious adverse events
|
7 Participants
|
|
Safety and Tolerability of Treatment as Assessed by Incidence of Adverse Events
Number of participants with any treatment-related serious adverse events
|
0 Participants
|
SECONDARY outcome
Timeframe: At 48 weeksPopulation: All enrolled patients who returned for primary endpoint assessment at week 48
Complete response is defined as histopathological regression to normal. The one-sample test of proportions will be used to compare the proportion of participants with HPV-16 and/or HPV-18 positive anal HSIL who were complete responders at 48 weeks after the first dose versus the proportion of participants with HPV-16 and/or HPV-18 positive anal HSIL who were not complete responders at 48 weeks after the first dose of HPV deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100.
Outcome measures
| Measure |
Treatment (VGX-3100, Electroporation)
n=37 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Complete Response Rate
|
4 Participants
|
SECONDARY outcome
Timeframe: At 48 weeksPopulation: Patients who received at least one dose of VGX-3100 and had the HSIL lesion positive along with HPV-16/18 positive in anal specimen at baseline
Viral clearance rate of HPV-16 and/or HPV-18 defined as changing from presence to absence of HPV-16/18 in anal HSIL by anal histological specimen. Proportions and their corresponding confidence intervals will be used to estimate the viral clearance rate of HPV-16 and HPV-18.
Outcome measures
| Measure |
Treatment (VGX-3100, Electroporation)
n=39 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Viral Clearance Histological Specimen
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksViral clearance rate of HPV-16 and/or HPV-18 defined as changing from presence to absence of HPV-16/18 in anal HSIL by anal swab. Proportions and their corresponding confidence intervals will be used to estimate the viral clearance rate of HPV-16 and HPV-18.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 72 weeksPopulation: Participants who received at least one vaccine VGX-3100 and has HSIL positive at baseline
Overall response rate defined as histopathological regression from HSIL to LSIL or normal.
Outcome measures
| Measure |
Treatment (VGX-3100, Electroporation)
n=33 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Response Rate at 72 Weeks
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 48 weeksDefined as histopathological regression of non-HPV-16 or HPV-18-positive HSIL to LSIL or AIN1 or normal. The one-sample test of proportions will be used to compare the proportion of non-HPV-16 or HPV-18-positive anal HSIL that achieve a complete or partial response (which is defined as histopathological regression from HSIL to LSIL or normal) versus the proportion of non-HPV-16 or HPV-18-positive anal HSIL that did not achieve a complete or partial response of at 48 weeks after the first dose of HPV DNA plasmids therapeutic vaccine VGX-3100.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, 26, 36, 48, 60, and 72 weeksA tobit regression model will be used to test the increase from baseline for all patients completing at least the 24-week dose.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, 26, 36, 48, 60, and 72 weeksTo assess the change in antibody responses, the Wilcoxon signed rank test will be used to test the change from baseline for all patients completing at least the 24-week dose.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, 26, 36, 48, 60, and 72 weeksAssess the association of the addition of fourth dose of HPV DNA plasmids therapeutic vaccine VGX-3100 with T-cell responses.A tobit regression model will be used to test the increase from baseline for all patients completing at least the 24-week dose who receive a fourth dose of VGX-3100.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, 26, 36, 48, 60, and 72 weeksAssess the association of the addition of fourth dose of HPV DNA plasmids therapeutic vaccine VGX-3100 with antibody responses. To assess the change in antibody responses, the Wilcoxon signed rank test will be used to test the change from baseline for all patients completing at least the 24-week dose.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 72 weeksPopulation: Patients with available absolute CD4 count at baseline and at week 72
A paired t-test will be used to assess the effect of HPV DNA plasmids therapeutic vaccine VGX-3100 on CD4+ lymphocyte count over time by comparing the CD4 counts at each time-point to participant baseline values.
Outcome measures
| Measure |
Treatment (VGX-3100, Electroporation)
n=33 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Changes in CD4+ Lymphocyte Count
CD4 count at baseline
|
870.8 CD4+ T cells per cubic millimeter
Standard Deviation 442
|
|
Changes in CD4+ Lymphocyte Count
CD4 count at 72 weeks
|
916.5 CD4+ T cells per cubic millimeter
Standard Deviation 471.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 72 weeksChanges in in human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) over time will be assessed over time. A paired t-test will be used to assess the effect of HPV DNA plasmids therapeutic vaccine VGX-3100 on HIV-1 RNA over time by comparing the viral loads at each time-point to participant baseline values.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up 48 weeksPopulation: Patients with CD4 data at week 48, who receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation for 4 doses at week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Will assess association of CD4+ lymphocyte count in participants with a complete response at 48 weeks after the first dose of HPV DNA plasmids therapeutic vaccine VGX-3100. The two-sample t-test will be used to compare the CD4+ lymphocyte counts between those with an complete response and those without.
Outcome measures
| Measure |
Treatment (VGX-3100, Electroporation)
n=34 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Mean CD4+ Lymphocyte Count by Complete Response Status
CD4 count among participants with CR at week 48
|
842 cells/mm3
Standard Deviation 339.2
|
|
Mean CD4+ Lymphocyte Count by Complete Response Status
CD4 count among participants with lack of CR at week 48
|
813.9 cells/mm3
Standard Deviation 347
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up 48 weeksPopulation: Participants with available response data and CD4 count data at week 48
Will assess association of CD4+ lymphocyte count in participants with an overall response at 48 weeks after the first dose of HPV DNA plasmids therapeutic vaccine VGX-3100. The two-sample t-test will be used to compare the CD4+ lymphocyte counts between those with an overall response to those without.
Outcome measures
| Measure |
Treatment (VGX-3100, Electroporation)
n=34 Participants
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Mean CD4+ Lymphocyte Count by Overall Response Status
Mean CD4 count among participants with Overall response at 48 weeks
|
897.9 cells/mm3
Standard Deviation 287.1
|
|
Mean CD4+ Lymphocyte Count by Overall Response Status
Mean CD4 count among participants with no Overall response at 48 weeks
|
783.5 cells/mm3
Standard Deviation 361.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up 48 weeksWill assess the effect of tissue PD-L1 expression on clinical benefit. Chi-square test or Fisher's exact test, as appropriate, will be used to test the effect of tissue PD-L1 expression on overall response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up 48 weeksWill assess the effect of T-cell infiltration on clinical benefit. Chi-square test or Fisher's exact test, as appropriate, will be used to test the effect of T-cell infiltration on overall response.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (VGX-3100, Electroporation)
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (VGX-3100, Electroporation)
n=43 participants at risk
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Infections and infestations
LUNG INFECTION
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Investigations
CPK INCREASED
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
Other adverse events
| Measure |
Treatment (VGX-3100, Electroporation)
n=43 participants at risk
Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.
Electroporation: Undergo electroporation
HPV DNA Plasmids Therapeutic Vaccine VGX-3100: Given IM
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
4.7%
2/43 • Number of events 3 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Blood and lymphatic system disorders
ANEMIA
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Eye disorders
WATERING EYES
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
DIARRHEA
|
14.0%
6/43 • Number of events 9 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
NAUSEA
|
11.6%
5/43 • Number of events 12 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
ANAL PAIN
|
7.0%
3/43 • Number of events 3 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
ANAL ULCER
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
ORAL PAIN
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
RECTAL PAIN
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Gastrointestinal disorders
TOOTHACHE
|
2.3%
1/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
General disorders
PAIN
|
34.9%
15/43 • Number of events 55 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
General disorders
FATIGUE
|
23.3%
10/43 • Number of events 31 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
General disorders
INJECTION SITE REACTION
|
16.3%
7/43 • Number of events 21 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
General disorders
MALAISE
|
16.3%
7/43 • Number of events 21 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
9.3%
4/43 • Number of events 29 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
General disorders
EDEMA LIMBS
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
General disorders
FEVER
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
General disorders
FLU LIKE SYMPTOMS
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Immune system disorders
ALLERGIC REACTION
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
11.6%
5/43 • Number of events 5 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Infections and infestations
CONJUNCTIVITIS INFECTIVE
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Infections and infestations
RASH PUSTULAR
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Infections and infestations
SINUSITIS
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Injury, poisoning and procedural complications
BRUISING
|
7.0%
3/43 • Number of events 4 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Injury, poisoning and procedural complications
VACCINATION COMPLICATION
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Investigations
CPK INCREASED
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Metabolism and nutrition disorders
OBESITY
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
23.3%
10/43 • Number of events 34 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.6%
8/43 • Number of events 24 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.7%
2/43 • Number of events 4 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.3%
1/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Nervous system disorders
HEADACHE
|
25.6%
11/43 • Number of events 27 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Nervous system disorders
DIZZINESS
|
4.7%
2/43 • Number of events 5 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Nervous system disorders
PARESTHESIA
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Nervous system disorders
SOMNOLENCE
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Psychiatric disorders
DEPRESSION
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Psychiatric disorders
INSOMNIA
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
2.3%
1/43 • Number of events 3 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL INFLAMMATION
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.3%
7/43 • Number of events 11 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
SKIN INDURATION
|
7.0%
3/43 • Number of events 5 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
2.3%
1/43 • Number of events 1 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
|
7.0%
3/43 • Number of events 3 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
|
Vascular disorders
HYPERTENSION
|
4.7%
2/43 • Number of events 2 • All participants will be followed for up to 72 weeks after receiving the first dose of VGX-3100, diagnosis of invasive anal cancer, or until death, whichever occurs first.
|
Additional Information
Himanshu Joshi, MBBS, MPH, PhD
Icahn School of Medicine at Mount Sinai
Phone: 2122599635
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place