Trial Outcomes & Findings for A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions (NCT NCT02481414)
NCT ID: NCT02481414
Last Updated: 2023-12-18
Results Overview
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
15 months from time of last vaccination
Results posted on
2023-12-18
Participant Flow
Participant milestones
| Measure |
PepCan
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
42
|
|
Overall Study
COMPLETED
|
35
|
41
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
Baseline characteristics by cohort
| Measure |
PepCan
n=39 Participants
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
n=42 Participants
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
31.3 years
n=99 Participants
|
31.4 years
n=107 Participants
|
31.3 years
n=206 Participants
|
|
Age, Customized
<25 years - number (no.)
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Customized
≥25 years - number (no.)
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
34 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Histological Diagnosis at Study Entry
CIN3 and CIN2/3
|
29 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Histological Diagnosis at Study Entry
CIN2
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Number (No.) of cervical quadrants
|
1.89 cervical quadrants
STANDARD_DEVIATION 1.06 • n=99 Participants
|
2.05 cervical quadrants
STANDARD_DEVIATION 1.02 • n=107 Participants
|
1.97 cervical quadrants
STANDARD_DEVIATION 1.04 • n=206 Participants
|
|
Body mass index
|
27.3 kg/m^2
STANDARD_DEVIATION 6.2 • n=99 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 7.3 • n=107 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
Albumin < 3.5 g/dL
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Total protein < 6.4 g/dL
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Human papillomavirus (HPV) prophylactic vaccine
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Any college
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Any children
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
≥ 5 sexual partners
|
19 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ever smoked
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Currently smoke
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ever used oral contraceptives
|
27 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Currently use oral contraceptives
|
6 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Number (No.) of cervical quadrants
>2 quadrants
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Number (No.) of cervical quadrants
≤2 quadrants
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Number (No.) of cervical quadrants
Data not available
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Body mass index
≥25 kg/m^2 - <30 kg/m^2
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Body mass index
≥30 kg/m^2
|
11 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Body mass index
<25 kg/m^2
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 15 months from time of last vaccinationPopulation: ITT (subjects who were eligible and randomized)
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)
Outcome measures
| Measure |
PepCan
n=39 Participants
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
n=42 Participants
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
|---|---|---|
|
Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis
|
12 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 15 months from time of last vaccinationPopulation: Per-protocol (subjects who completed the 12-month visit)
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)".
Outcome measures
| Measure |
PepCan
n=24 Participants
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
n=29 Participants
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
|---|---|---|
|
Number of Subjects With Complete Response With the Per-protocol Analysis
|
11 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 15 months from time of last vaccinationPopulation: ITT (subjects who were eligible and randomized)
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
Outcome measures
| Measure |
PepCan
n=39 Participants
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
n=42 Participants
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
|---|---|---|
|
Number of Subjects With Complete and Partial Responses With the ITT Analysis
|
15 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 15 months from time of last vaccinationPopulation: Per-protocol (subjects who completed the 12-month visit)
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
Outcome measures
| Measure |
PepCan
n=24 Participants
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
n=29 Participants
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
|---|---|---|
|
Number of Subjects With Complete and Partial Responses With the Per-protocol Analysis
|
13 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 15 months from time of last vaccinationPopulation: Number of Injections for ITT (subjects who were eligible and randomized)
Injection-related AEs occurring in \>5% of injections
Outcome measures
| Measure |
PepCan
n=152 Number of Injections
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
n=164 Number of Injections
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
|---|---|---|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Fever : Grade 1
|
9 Adverse Events
|
3 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Fever : Grade 2
|
1 Adverse Events
|
0 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Fever : All Grades
|
10 Adverse Events
|
3 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Headache : Grade 1
|
13 Adverse Events
|
15 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Headache : Grade 2
|
4 Adverse Events
|
3 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Headache : All Grades
|
17 Adverse Events
|
18 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Injection site reaction, < 24 h : Grade 1
|
63 Adverse Events
|
58 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Injection site reaction, < 24 h : Grade 2
|
25 Adverse Events
|
31 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Injection site reaction, < 24 h : All Grades
|
88 Adverse Events
|
89 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Myalgia : Grade 1
|
35 Adverse Events
|
9 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Myalgia : Grade 2
|
2 Adverse Events
|
1 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Myalgia : All Grades
|
37 Adverse Events
|
10 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Nausea : Grade 1
|
19 Adverse Events
|
18 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Nausea : Grade 2
|
0 Adverse Events
|
0 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Nausea : All Grades
|
19 Adverse Events
|
18 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Injection site reaction, ≥ 24 h : Grade 1
|
23 Adverse Events
|
39 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Injection site reaction, ≥ 24 h : Grade 2
|
31 Adverse Events
|
18 Adverse Events
|
|
Safety Assessed by Injection-related Adverse Events (AEs)
Injection site reaction, ≥ 24 h : All Grades
|
54 Adverse Events
|
57 Adverse Events
|
Adverse Events
PepCan
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Candin
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PepCan
n=39 participants at risk
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
n=42 participants at risk
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Pregnancy, puerperium and perinatal conditions
Fetal Death
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Psychiatric disorders
Psychiatric Disorders - Other Specify
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
Other adverse events
| Measure |
PepCan
n=39 participants at risk
Four injections (one every 3 weeks) of PepCan
PepCan: 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
|
Candin
n=42 participants at risk
Four injections (one every 3 weeks) of Candin
Candin®: 0.3 mL Candin® per dose administered intradermally in the extremities
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.1%
9/39 • Number of events 9 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
16.7%
7/42 • Number of events 8 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Cardiac disorders
Sinus Tachycardia
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Ear and labyrinth disorders
Ear Pain
|
2.6%
1/39 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
7.1%
3/42 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Eye disorders
Photophobia
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Eye disorders
Eye Disorders 0 Other, Specify
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.3%
4/39 • Number of events 6 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Constipation
|
10.3%
4/39 • Number of events 6 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Gastroparesis
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Nausea
|
38.5%
15/39 • Number of events 31 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
28.6%
12/42 • Number of events 22 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Stomach Pain
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Vomitting
|
7.7%
3/39 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Specify
|
7.7%
3/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
9.5%
4/42 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Edema Limbs
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Fatigue
|
20.5%
8/39 • Number of events 9 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
16.7%
7/42 • Number of events 9 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Fever
|
25.6%
10/39 • Number of events 14 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
9.5%
4/42 • Number of events 5 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Flu-like Symptoms
|
15.4%
6/39 • Number of events 8 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
9.5%
4/42 • Number of events 5 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Injection Site Reaction
|
87.2%
34/39 • Number of events 142 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
90.5%
38/42 • Number of events 146 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Localized Edema
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Malaise
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
General disorders
Pain
|
7.7%
3/39 • Number of events 8 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
9.5%
4/42 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Immune system disorders
Allergic Reaction
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Laryngitis
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Pharyngitis
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Sinusitis
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Tooth Infection
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Upper Respiratory Infection
|
15.4%
6/39 • Number of events 9 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Urinary Tract Infection
|
12.8%
5/39 • Number of events 7 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
9.5%
4/42 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Vaginal Infection
|
10.3%
4/39 • Number of events 5 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
11.9%
5/42 • Number of events 5 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Infections and Infestations - Others, Specify
|
7.7%
3/39 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
9.5%
4/42 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Injury, poisoning and procedural complications
Bruising
|
10.3%
4/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Alanine Aminotransferase Increased
|
20.5%
8/39 • Number of events 8 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
11.9%
5/42 • Number of events 5 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Alkaline Phosphatase Increased
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Blood Bilirubin Increased
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Creatinine Increased
|
12.8%
5/39 • Number of events 5 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
7.1%
3/42 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Hemoglobin Increased
|
7.7%
3/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Platelet Count Decreased
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Weight Loss
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
White Blood Cell Decreased
|
2.6%
1/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Investigations - Other, Specify
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
3/39 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
3/39 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
21.4%
9/42 • Number of events 9 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
3/39 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
9.5%
4/42 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.9%
7/39 • Number of events 7 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
23.8%
10/42 • Number of events 12 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.8%
5/39 • Number of events 7 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Obesity
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
7.1%
3/42 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.8%
12/39 • Number of events 44 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
21.4%
9/42 • Number of events 12 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder - Other, Specify
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Concentration Impairement
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Dizziness
|
17.9%
7/39 • Number of events 8 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
11.9%
5/42 • Number of events 10 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Headache
|
25.6%
10/39 • Number of events 25 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
28.6%
12/42 • Number of events 25 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Lethargy
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Paresthesia
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Somnolence
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Nervous system disorders
Nervous System Disorders - Other, Specify
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Pregnancy, puerperium and perinatal conditions
Unintended Pregnancy
|
10.3%
4/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
7.1%
3/42 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Psychiatric disorders
Anxiety
|
10.3%
4/39 • Number of events 6 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
7.1%
3/42 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Psychiatric disorders
Depression
|
5.1%
2/39 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Psychiatric disorders
Psychiatric Disorders - Other, Specify
|
7.7%
3/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Renal and urinary disorders
Hemturia
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Renal and urinary disorders
Urinary Urgency
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Renal and urinary disorders
Renal and Urinary Disorders - Other, Specify
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Breast Pain
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
10.3%
4/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Dyspareunia
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
10.3%
4/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
7.1%
3/42 • Number of events 3 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Vaginal Pain
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Vaginismus
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders - Other, Specify
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 5 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.1%
2/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
4.8%
2/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.3%
4/39 • Number of events 6 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other, Specify
|
10.3%
4/39 • Number of events 4 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
14.3%
6/42 • Number of events 6 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Vascular disorders
Hot Flashes
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Vascular disorders
Hypertension
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/39 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
2.6%
1/39 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.1%
2/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
0.00%
0/42 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
15.4%
6/39 • Number of events 7 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
16.7%
7/42 • Number of events 7 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
|
Infections and infestations
Skin Infection
|
2.6%
1/39 • Number of events 2 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
2.4%
1/42 • Number of events 1 • Time of enrollment until 15 months from time of last vaccination, approximately 18 months
|
Additional Information
Matthew Kovak, Director of Clinical Trials
University of Arkansas for Medical Sciences
Phone: 501-686-8274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place