Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults (NCT NCT02826798)
NCT ID: NCT02826798
Last Updated: 2020-04-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
128 participants
Primary outcome timeframe
Day of vaccine administration (days 0, 56, 168) and six subsequent days
Results posted on
2020-04-20
Participant Flow
Participant milestones
| Measure |
VBI-1501A: 0.5µg With Adjuvant
Healthy cytomegalovirus (CMV)-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
26
|
25
|
26
|
|
Overall Study
COMPLETED
|
25
|
25
|
26
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
VBI-1501A: 0.5µg With Adjuvant
Healthy cytomegalovirus (CMV)-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
Mean (standard deviation)
|
26.4 years
STANDARD_DEVIATION 4.58 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 5.38 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 4.60 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 5.99 • n=4 Participants
|
28.3 years
STANDARD_DEVIATION 5.58 • n=21 Participants
|
27.0 years
STANDARD_DEVIATION 5.22 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
76 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
North American Indian
|
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
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White, Caucasian
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
115 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Filipino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
26 participants
n=5 Participants
|
25 participants
n=4 Participants
|
26 participants
n=21 Participants
|
128 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day of vaccine administration (days 0, 56, 168) and six subsequent daysPopulation: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
Outcome measures
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=23 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Pain at injection site, Dose 1
|
11 Participants
|
14 Participants
|
13 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Pain at injection site, Dose 2
|
10 Participants
|
15 Participants
|
14 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Pain at injection site, Dose 3
|
10 Participants
|
13 Participants
|
13 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Fatigue, Dose 1
|
9 Participants
|
8 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Fatigue, Dose 2
|
9 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Fatigue, Dose 3
|
10 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Diarrhea, Dose 1
|
6 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Diarrhea, Dose 2
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Diarrhea, Dose 3
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Nausea/Vomiting, Dose 1
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Nausea/Vomiting, Dose 2
|
2 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Nausea/Vomiting, Dose 3
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Headache, Dose 1
|
9 Participants
|
11 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Headache, Dose 2
|
11 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Headache, Dose 3
|
7 Participants
|
12 Participants
|
9 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Malaise, Dose 1
|
8 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Malaise, Dose 2
|
5 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Malaise, Dose 3
|
5 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Myalgia, Dose 1
|
6 Participants
|
11 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Myalgia, Dose 2
|
2 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Myalgia, Dose 3
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Neck Swelling, Dose 1
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Neck Swelling, Dose 2
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Neck Swelling, Dose 3
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Armpit Swelling, Dose 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Armpit Swelling, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Armpit Swelling, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
Outcome measures
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=23 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event
Post-Dose 2
|
8 Participants
|
11 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Any Adverse Event
Post-Dose 1
|
12 Participants
|
11 Participants
|
10 Participants
|
10 Participants
|
15 Participants
|
|
Number of Participants With Any Adverse Event
Post-Dose 3
|
7 Participants
|
13 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Any Adverse Event
Through Day 336 or Early Withdrawal
|
18 Participants
|
22 Participants
|
19 Participants
|
19 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Through Day 336 or early withdrawalPopulation: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
Outcome measures
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=23 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Number of Participants With Any Serious Adverse Event
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Day 336 or early withdrawalPopulation: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
Blood and urine samples were collected at screening for all evaluations with additional blood samples obtained on Days 28, 56, 84, 168, 196, 280, and 336. The following clinical laboratory evaluations were performed: Biochemistry: alanine aminotransferase; aspartate aminotransferase; creatinine; blood urea nitrogen; Hematology: neutrophils, lymphocytes, eosinophils, hemoglobin, platelet count, white blood cell count; Infection status: HIV, hepatitis B, hepatitis C, and cytomegalovirus; and Urinalysis: blood, glucose, protein.
Outcome measures
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=23 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Day 28
|
14 Participants
|
10 Participants
|
15 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Day 56
|
13 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
11 Participants
|
|
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Day 84
|
13 Participants
|
11 Participants
|
13 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Day 168
|
16 Participants
|
11 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Day 196
|
12 Participants
|
13 Participants
|
15 Participants
|
13 Participants
|
11 Participants
|
|
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Day 280
|
14 Participants
|
13 Participants
|
13 Participants
|
13 Participants
|
16 Participants
|
|
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Day 336
|
14 Participants
|
14 Participants
|
16 Participants
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Through Day 336 or early withdrawalPopulation: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. The group means and standard deviations of positive samples are shown, except where no samples tested positive (neither mean nor standard deviation could be calculated) or only one sample tested positive (standard deviation could not be calculated).
Outcome measures
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=23 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Binding to CMV gB
Day 0
|
1126.00 Titer
Standard Deviation NA
Standard deviation not calculated because only one participant's sample measured above the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
1077.29 Titer
Standard Deviation 1.85
|
505.00 Titer
Standard Deviation NA
Standard deviation not calculated because only one participant's sample measured above the assay cut point
|
|
Geometric Mean Titer of Antibody Binding to CMV gB
Day 28
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
863.00 Titer
Standard Deviation NA
Standard deviation not calculated because only one participant's sample measured above the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
1493.80 Titer
Standard Deviation 2.05
|
580.3 Titer
Standard Deviation 1.15
|
|
Geometric Mean Titer of Antibody Binding to CMV gB
Day 56
|
1461.82 Titer
Standard Deviation 1.15
|
933.07 Titer
Standard Deviation 1.16
|
691.90 Titer
Standard Deviation 1.21
|
1468.22 Titer
Standard Deviation 1.93
|
1072.06 Titer
Standard Deviation 1.41
|
|
Geometric Mean Titer of Antibody Binding to CMV gB
Day 84
|
7410.59 Titer
Standard Deviation 2.59
|
10378.98 Titer
Standard Deviation 2.87
|
15212.90 Titer
Standard Deviation 2.54
|
3097.78 Titer
Standard Deviation 3.24
|
1306.99 Titer
Standard Deviation 1.01
|
|
Geometric Mean Titer of Antibody Binding to CMV gB
Day 168
|
2578.32 Titer
Standard Deviation 2.04
|
3554.05 Titer
Standard Deviation 2.48
|
5344.20 Titer
Standard Deviation 3.38
|
1901.01 Titer
Standard Deviation 2.00
|
1241.41 Titer
Standard Deviation 3.21
|
|
Geometric Mean Titer of Antibody Binding to CMV gB
Day 196
|
24832.80 Titer
Standard Deviation 3.56
|
32600.15 Titer
Standard Deviation 3.27
|
48189.54 Titer
Standard Deviation 2.73
|
12579.63 Titer
Standard Deviation 5.79
|
2086.94 Titer
Standard Deviation 1.91
|
|
Geometric Mean Titer of Antibody Binding to CMV gB
Day 280
|
8736.27 Titer
Standard Deviation 4.24
|
13564.41 Titer
Standard Deviation 3.06
|
25574.36 Titer
Standard Deviation 3.65
|
5877.74 Titer
Standard Deviation 5.45
|
3115.63 Titer
Standard Deviation 1.35
|
|
Geometric Mean Titer of Antibody Binding to CMV gB
Day 336
|
4977.61 Titer
Standard Deviation 3.09
|
9543.19 Titer
Standard Deviation 3.58
|
12351.83 Titer
Standard Deviation 3.79
|
3719.56 Titer
Standard Deviation 3.80
|
2907.15 Titer
Standard Deviation 5.73
|
SECONDARY outcome
Timeframe: Through Day 336 or early withdrawalPopulation: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
To measure the avidity of responses against CMV gB protein, a standard ELISA assay using recombinant gB protein which did or did not include treatment with 5M urea for 30 minutes of samples after sera had been incubated with recombinant protein. The reported value, or Avidity Index, represents the percent of signal measured in ELISA after treatment with urea relative to samples not exposed to urea.
Outcome measures
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=23 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Avidity Index Value Against gB
Day 28
|
38.98 Avidity index
Standard Deviation 1.79
|
41.83 Avidity index
Standard Deviation 1.47
|
33.81 Avidity index
Standard Deviation 1.52
|
35.53 Avidity index
Standard Deviation 2.72
|
38.67 Avidity index
Standard Deviation 1.85
|
|
Geometric Mean Titer of Antibody Avidity Index Value Against gB
Day 84
|
64.56 Avidity index
Standard Deviation 1.20
|
64.77 Avidity index
Standard Deviation 1.22
|
71.91 Avidity index
Standard Deviation 1.15
|
57.73 Avidity index
Standard Deviation 1.55
|
47.55 Avidity index
Standard Deviation 2.10
|
|
Geometric Mean Titer of Antibody Avidity Index Value Against gB
Day 196
|
77.17 Avidity index
Standard Deviation 1.14
|
79.58 Avidity index
Standard Deviation 1.13
|
83.43 Avidity index
Standard Deviation 1.07
|
69.71 Avidity index
Standard Deviation 1.29
|
36.39 Avidity index
Standard Deviation 2.84
|
|
Geometric Mean Titer of Antibody Avidity Index Value Against gB
Day 336
|
74.82 Avidity index
Standard Deviation 1.18
|
75.86 Avidity index
Standard Deviation 1.13
|
80.81 Avidity index
Standard Deviation 1.09
|
66.43 Avidity index
Standard Deviation 1.39
|
44.20 Avidity index
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Through Day 196 or early withdrawalPopulation: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. Samples with antibody titers below the assay cut point were not included in the calculation of geometric mean or standard deviation.
Outcome measures
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=23 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells
Day 84
|
77.48 Titer
Standard Deviation 1.98
|
88.80 Titer
Standard Deviation 2.19
|
140.38 Titer
Standard Deviation 2.35
|
107.06 Titer
Standard Deviation 2.41
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
|
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells
Day 196
|
139.40 Titer
Standard Deviation 2.67
|
165.25 Titer
Standard Deviation 2.29
|
254.31 Titer
Standard Deviation 2.73
|
101.10 Titer
Standard Deviation 3.35
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
SECONDARY outcome
Timeframe: Through Day 336 or early withdrawalPopulation: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. The group means and standard deviations of positive samples are shown, except where no samples tested positive (neither mean nor standard deviation could be calculated) or only one sample tested positive (standard deviation could not be calculated).
Outcome measures
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=25 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=23 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 Participants
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
Day 336
|
151.00 Titer
Standard Deviation NA
Standard deviation not calculated because only one participant's sample measured above the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
234.80 Titer
Standard Deviation 1.82
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
|
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
Day 28
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
|
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
Day 84
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
221.28 Titer
Standard Deviation 1.57
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
|
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
Day 168
|
151.00 Titer
Standard Deviation NA
Standard deviation not calculated because only one participant's sample measured above the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
177.00 Titer
Standard Deviation NA
Standard deviation not calculated because only one participant's sample measured above the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
|
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
Day 196
|
159.69 Titer
Standard Deviation 1.11
|
281.00 Titer
Standard Deviation NA
Standard deviation not calculated because only one participant's sample measured above the assay cut point
|
287.24 Titer
Standard Deviation 1.45
|
261.95 Titer
Standard Deviation 1.17
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
|
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
Day 280
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
152.00 Titer
Standard Deviation NA
Standard deviation not calculated because only one participant's sample measured above the assay cut point
|
288.17 Titer
Standard Deviation 1.69
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
NA Titer
Standard Deviation NA
Geometric mean and standard deviation not calculated because all samples measured below the assay cut point
|
Adverse Events
VBI-1501A: 0.5µg With Adjuvant
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
VBI-1501A: 1.0µg With Adjuvant
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
VBI-1501A: 2.0 µg With Adjuvant
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
VBI-1501: 1.0µg Without Adjuvant
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=26 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=26 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=25 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Infections and infestations
Meningitis Aseptic
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Psychiatric disorders
Depression
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
Other adverse events
| Measure |
VBI-1501A: 0.5µg With Adjuvant
n=25 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 1.0µg With Adjuvant
n=26 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501A: 2.0 µg With Adjuvant
n=26 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
VBI-1501: 1.0µg Without Adjuvant
n=25 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
Placebo
n=26 participants at risk
Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 4 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 3 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
General disorders
Chills
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
General disorders
Fatigue
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
15.4%
4/26 • Number of events 4 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
General disorders
Malaise
|
16.0%
4/25 • Number of events 4 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 3 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Infections and infestations
Nasopharyngitis
|
44.0%
11/25 • Number of events 15 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
19.2%
5/26 • Number of events 9 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
34.6%
9/26 • Number of events 14 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
24.0%
6/25 • Number of events 8 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
30.8%
8/26 • Number of events 10 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Infections and infestations
Pharyngitis
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Infections and infestations
Sinusitis
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.0%
4/25 • Number of events 4 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
26.9%
7/26 • Number of events 10 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
12.0%
3/25 • Number of events 4 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
11.5%
3/26 • Number of events 5 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Infections and infestations
Urinary Tract Infection
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
15.4%
4/26 • Number of events 4 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Injury, poisoning and procedural complications
Laceration
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.0%
2/25 • Number of events 4 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Nervous system disorders
Headache
|
24.0%
6/25 • Number of events 9 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
30.8%
8/26 • Number of events 12 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
19.2%
5/26 • Number of events 8 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
24.0%
6/25 • Number of events 6 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
19.2%
5/26 • Number of events 10 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.0%
1/25 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 4 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/25 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
|
Respiratory, thoracic and mediastinal disorders
Orophyngeal Pain
|
16.0%
4/25 • Number of events 5 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
8.0%
2/25 • Number of events 3 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place