Trial Outcomes & Findings for A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects (NCT NCT00857493)
NCT ID: NCT00857493
Last Updated: 2019-01-10
Results Overview
Incidence of Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine
COMPLETED
PHASE2
120 participants
within 8 weeks
2019-01-10
Participant Flow
Participant milestones
| Measure |
Group 1
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
58
|
|
Overall Study
COMPLETED
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects
Baseline characteristics by cohort
| Measure |
Group 1
n=62 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 5.41 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 5.85 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 5.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 8 weeksPopulation: Safety Analysis Set
Incidence of Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine
Outcome measures
| Measure |
Group 1
n=62 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Related Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Safety Analysis Set
Occurrence of unsolicited non-serious AEs by Intensity
Outcome measures
| Measure |
Group 1
n=62 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Unsolicited Non-serious AEs: Intensity
Missing
|
0 events
|
0 events
|
|
Unsolicited Non-serious AEs: Intensity
Total
|
73 events
|
58 events
|
|
Unsolicited Non-serious AEs: Intensity
Grade 1
|
60 events
|
50 events
|
|
Unsolicited Non-serious AEs: Intensity
Grade 2
|
9 events
|
7 events
|
|
Unsolicited Non-serious AEs: Intensity
Grade 3
|
4 events
|
1 events
|
|
Unsolicited Non-serious AEs: Intensity
Grade 4
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Safety Analysis Set
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Outcome measures
| Measure |
Group 1
n=62 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Unrelated/None
|
32 events
|
26 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Unlikely
|
6 events
|
2 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Possible
|
20 events
|
13 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Probable
|
8 events
|
5 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Definite
|
7 events
|
12 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Missing
|
0 events
|
0 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Total
|
73 events
|
58 events
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Safety Analysis Set
Incidence of any Grade \>=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general) and unsolicited AEs
Outcome measures
| Measure |
Group 1
n=62 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Related Grade >=3 Adverse Events
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Safety Analysis Set
Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzymes elevated above 2 x upper limit of normal range (ULN).
Outcome measures
| Measure |
Group 1
n=62 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Cardiac Signs or Symptoms
Any AESI
|
5 Participants
|
0 Participants
|
|
Cardiac Signs or Symptoms
Any AESI with intensity >= Grade 3
|
0 Participants
|
0 Participants
|
|
Cardiac Signs or Symptoms
Any AESI assessed as related to vaccine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 8 days after any vaccinationPopulation: Safety Analysis Set
Incidence and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritus). Percentages based on subjects with at least one completed diary card.
Outcome measures
| Measure |
Group 1
n=62 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Solicited Local Adverse Events
Pain: Grade >=3
|
4 Participants
|
1 Participants
|
|
Solicited Local Adverse Events
Erythema: Any
|
49 Participants
|
37 Participants
|
|
Solicited Local Adverse Events
Erythema: Grade >=3
|
3 Participants
|
1 Participants
|
|
Solicited Local Adverse Events
Pain: Any
|
46 Participants
|
36 Participants
|
|
Solicited Local Adverse Events
Swelling: Any
|
39 Participants
|
27 Participants
|
|
Solicited Local Adverse Events
Swelling: Grade >=3
|
0 Participants
|
0 Participants
|
|
Solicited Local Adverse Events
Induration: Any
|
31 Participants
|
17 Participants
|
|
Solicited Local Adverse Events
Induration: Grade >=3
|
0 Participants
|
0 Participants
|
|
Solicited Local Adverse Events
Pruritis: Any
|
27 Participants
|
22 Participants
|
|
Solicited Local Adverse Events
Pruritis: Grade >=3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 8 days after any vaccinationPopulation: Safety Analysis Set
Incidence of solicited general AEs (body temperature increased, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship tovaccination. Percentages based on subjects with at least one completed diary card.
Outcome measures
| Measure |
Group 1
n=62 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Solicited General Adverse Events
Nausea: Related
|
4 Participants
|
4 Participants
|
|
Solicited General Adverse Events
Nausea: Grade >=3
|
0 Participants
|
0 Participants
|
|
Solicited General Adverse Events
Increased body temperature: Any
|
2 Participants
|
1 Participants
|
|
Solicited General Adverse Events
Increased body temperature: Related
|
2 Participants
|
0 Participants
|
|
Solicited General Adverse Events
Increased body temperature: Grade >=3
|
0 Participants
|
0 Participants
|
|
Solicited General Adverse Events
Headache: Any
|
19 Participants
|
22 Participants
|
|
Solicited General Adverse Events
Headache: Related
|
15 Participants
|
14 Participants
|
|
Solicited General Adverse Events
Headache: Grade >=3
|
1 Participants
|
0 Participants
|
|
Solicited General Adverse Events
Myalgia: Any
|
19 Participants
|
14 Participants
|
|
Solicited General Adverse Events
Myalgia: Related
|
14 Participants
|
12 Participants
|
|
Solicited General Adverse Events
Myalgia: Grade >=3
|
2 Participants
|
1 Participants
|
|
Solicited General Adverse Events
Chills: Any
|
5 Participants
|
4 Participants
|
|
Solicited General Adverse Events
Chills: Related
|
5 Participants
|
1 Participants
|
|
Solicited General Adverse Events
Chills: Grade >=3
|
0 Participants
|
0 Participants
|
|
Solicited General Adverse Events
Nausea: Any
|
7 Participants
|
5 Participants
|
|
Solicited General Adverse Events
Fatigue: Any
|
21 Participants
|
18 Participants
|
|
Solicited General Adverse Events
Fatigue: Related
|
18 Participants
|
15 Participants
|
|
Solicited General Adverse Events
Fatigue: Grade >=3
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Full Analysis Set
Response rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak response rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Group 1
n=61 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
ELISA Response Rate
Week 6
|
98.3 percentage of subjects
Interval 91.1 to 100.0
|
96.6 percentage of subjects
Interval 88.1 to 99.6
|
|
ELISA Response Rate
Week 8
|
100.0 percentage of subjects
Interval 93.9 to 100.0
|
100.0 percentage of subjects
Interval 93.8 to 100.0
|
|
ELISA Response Rate
Individual Peak
|
100.0 percentage of subjects
Interval 94.1 to 100.0
|
100.0 percentage of subjects
Interval 93.8 to 100.0
|
|
ELISA Response Rate
Week 32
|
94.9 percentage of subjects
Interval 85.9 to 98.9
|
82.8 percentage of subjects
Interval 70.6 to 91.4
|
|
ELISA Response Rate
Week 2
|
98.4 percentage of subjects
Interval 91.2 to 100.0
|
19.0 percentage of subjects
Interval 9.9 to 31.4
|
|
ELISA Response Rate
Week 4
|
96.6 percentage of subjects
Interval 88.3 to 99.6
|
19.0 percentage of subjects
Interval 9.9 to 31.4
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Full Analysis Set
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak seroconversion rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Group 1
n=61 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
ELISA Seroconversion Rate
Week 32
|
59.3 percentage of subjects
Interval 45.7 to 71.9
|
58.6 percentage of subjects
Interval 44.9 to 71.4
|
|
ELISA Seroconversion Rate
Week 8
|
83.1 percentage of subjects
Interval 71.0 to 91.6
|
77.6 percentage of subjects
Interval 64.7 to 87.5
|
|
ELISA Seroconversion Rate
Individual Peak
|
90.2 percentage of subjects
Interval 79.8 to 96.3
|
84.5 percentage of subjects
Interval 72.6 to 92.7
|
|
ELISA Seroconversion Rate
Week 2
|
83.6 percentage of subjects
Interval 71.9 to 91.8
|
1.7 percentage of subjects
Interval 0.0 to 9.2
|
|
ELISA Seroconversion Rate
Week 4
|
79.7 percentage of subjects
Interval 67.2 to 89.0
|
3.4 percentage of subjects
Interval 0.4 to 11.9
|
|
ELISA Seroconversion Rate
Week 6
|
83.3 percentage of subjects
Interval 71.5 to 91.7
|
82.8 percentage of subjects
Interval 70.6 to 91.4
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Full Analysis Set
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1
n=61 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
ELISA GMT
Week 0
|
129.0 Titer
Interval 100.3 to 165.8
|
105.3 Titer
Interval 71.8 to 154.5
|
|
ELISA GMT
Week 2
|
622.5 Titer
Interval 491.2 to 788.9
|
98.5 Titer
Interval 64.8 to 150.0
|
|
ELISA GMT
Week 4
|
501.2 Titer
Interval 406.4 to 617.9
|
101.0 Titer
Interval 66.5 to 153.3
|
|
ELISA GMT
Week 6
|
804.1 Titer
Interval 636.3 to 1016.0
|
605.8 Titer
Interval 479.6 to 765.2
|
|
ELISA GMT
Week 8
|
720.2 Titer
Interval 577.9 to 897.6
|
505.0 Titer
Interval 398.2 to 640.3
|
|
ELISA GMT
Individual Peak
|
992.4 Titer
Interval 769.2 to 1280.3
|
645.2 Titer
Interval 505.0 to 824.3
|
|
ELISA GMT
Week 32
|
344.6 Titer
Interval 288.9 to 411.1
|
258.1 Titer
Interval 202.5 to 328.9
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Full Analysis Set
Response rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Response is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak response rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Group 1
n=61 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
PRNT Response Rate
Week 2
|
83.6 percentage of subjects
Interval 71.9 to 91.8
|
15.5 percentage of subjects
Interval 7.3 to 27.4
|
|
PRNT Response Rate
Week 4
|
81.4 percentage of subjects
Interval 69.1 to 90.3
|
10.3 percentage of subjects
Interval 3.9 to 21.2
|
|
PRNT Response Rate
Week 6
|
96.7 percentage of subjects
Interval 88.5 to 99.6
|
82.8 percentage of subjects
Interval 70.6 to 91.4
|
|
PRNT Response Rate
Week 8
|
89.8 percentage of subjects
Interval 79.2 to 96.2
|
79.3 percentage of subjects
Interval 66.6 to 88.8
|
|
PRNT Response Rate
Individual Peak
|
96.7 percentage of subjects
Interval 88.7 to 99.6
|
84.5 percentage of subjects
Interval 72.6 to 92.7
|
|
PRNT Response Rate
Week 32
|
66.1 percentage of subjects
Interval 52.6 to 77.9
|
50.0 percentage of subjects
Interval 36.6 to 63.4
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Full Analysis Set
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak seroconversion rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Group 1
n=61 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
PRNT Seroconversion Rate
Week 2
|
73.8 percentage of subjects
Interval 60.9 to 84.2
|
10.3 percentage of subjects
Interval 3.9 to 21.2
|
|
PRNT Seroconversion Rate
Week 4
|
71.2 percentage of subjects
Interval 57.9 to 82.2
|
8.6 percentage of subjects
Interval 2.9 to 19.0
|
|
PRNT Seroconversion Rate
Week 6
|
90.0 percentage of subjects
Interval 79.5 to 96.2
|
77.6 percentage of subjects
Interval 64.7 to 87.5
|
|
PRNT Seroconversion Rate
Week 8
|
86.4 percentage of subjects
Interval 75.0 to 94.0
|
74.1 percentage of subjects
Interval 61.0 to 84.7
|
|
PRNT Seroconversion Rate
Individual Peak
|
95.1 percentage of subjects
Interval 86.3 to 99.0
|
77.6 percentage of subjects
Interval 64.7 to 87.5
|
|
PRNT Seroconversion Rate
Week 32
|
55.9 percentage of subjects
Interval 42.4 to 68.8
|
41.4 percentage of subjects
Interval 28.6 to 55.1
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Full Analysis Set
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Individual peak is defined as the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1
n=61 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
PRNT GMT
Week 0
|
11.9 Titer
Interval 7.4 to 19.1
|
11.3 Titer
Interval 6.5 to 19.4
|
|
PRNT GMT
Week 2
|
111.4 Titer
Interval 72.0 to 172.2
|
9.2 Titer
Interval 5.3 to 15.8
|
|
PRNT GMT
Week 4
|
79.5 Titer
Interval 52.1 to 121.3
|
11.3 Titer
Interval 6.8 to 18.7
|
|
PRNT GMT
Week 6
|
210.3 Titer
Interval 146.1 to 302.7
|
126.7 Titer
Interval 82.4 to 194.8
|
|
PRNT GMT
Week 8
|
144.9 Titer
Interval 96.1 to 218.6
|
99.5 Titer
Interval 63.8 to 155.1
|
|
PRNT GMT
Individual Peak
|
257.6 Titer
Interval 178.6 to 371.5
|
139.6 Titer
Interval 89.2 to 218.5
|
|
PRNT GMT
Week 32
|
47.0 Titer
Interval 31.1 to 71.1
|
27.6 Titer
Interval 17.0 to 44.8
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Full Analysis Set
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Outcome measures
| Measure |
Group 1
n=61 Participants
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 Participants
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Correlation PRNT vs ELISA Titers
Week 2
|
0.704 Pearson correlation coefficient
Interval 0.546 to 0.81
|
0.489 Pearson correlation coefficient
Interval 0.261 to 0.661
|
|
Correlation PRNT vs ELISA Titers
Week 4
|
0.569 Pearson correlation coefficient
Interval 0.362 to 0.718
|
0.492 Pearson correlation coefficient
Interval 0.264 to 0.664
|
|
Correlation PRNT vs ELISA Titers
Week 6
|
0.660 Pearson correlation coefficient
Interval 0.484 to 0.781
|
0.697 Pearson correlation coefficient
Interval 0.531 to 0.808
|
|
Correlation PRNT vs ELISA Titers
Week 8
|
0.600 Pearson correlation coefficient
Interval 0.402 to 0.74
|
0.616 Pearson correlation coefficient
Interval 0.421 to 0.752
|
|
Correlation PRNT vs ELISA Titers
Week 32
|
0.500 Pearson correlation coefficient
Interval 0.276 to 0.668
|
0.654 Pearson correlation coefficient
Interval 0.472 to 0.778
|
Adverse Events
Group 1
Group 2
Serious adverse events
| Measure |
Group 1
n=62 participants at risk
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 participants at risk
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
1.6%
1/62
|
0.00%
0/58
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/62
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/62
|
3.4%
2/58
|
Other adverse events
| Measure |
Group 1
n=62 participants at risk
IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
|
Group 2
n=58 participants at risk
IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/62
|
5.2%
3/58
|
|
General disorders
Application site haematoma
|
0.00%
0/62
|
5.2%
3/58
|
|
General disorders
Injection site haematoma
|
1.6%
1/62
|
8.6%
5/58
|
|
General disorders
Injection site nodule
|
6.5%
4/62
|
3.4%
2/58
|
|
General disorders
Injection site pain
|
3.2%
2/62
|
0.00%
0/58
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
2/62
|
1.7%
1/58
|
|
Infections and infestations
Sinusitis
|
4.8%
3/62
|
0.00%
0/58
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
3/62
|
3.4%
2/58
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/62
|
3.4%
2/58
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
2/62
|
1.7%
1/58
|
|
Investigations
Lymphocyte count decreased
|
3.2%
2/62
|
0.00%
0/58
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/62
|
6.9%
4/58
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/62
|
3.4%
2/58
|
|
Nervous system disorders
Dizziness
|
4.8%
3/62
|
1.7%
1/58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place