Trial Outcomes & Findings for An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees (NCT NCT00686582)
NCT ID: NCT00686582
Last Updated: 2019-03-13
Results Overview
Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an 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 booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
within 4 weeks
Results posted on
2019-03-13
Participant Flow
Participant milestones
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Vaccinia Experienced, Boosted, Blood Draw Only
Group 4 Vaccinia Experienced
1 booster dose of MVA-BN in prior study (POX-MVA-005) Blood draw, Screening Visit only (POX-MVA-023)
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
91
|
121
|
|
Overall Study
Booster Vaccination
|
75
|
77
|
0
|
|
Overall Study
COMPLETED
|
74
|
77
|
121
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees
Baseline characteristics by cohort
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=92 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=91 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Vaccinia Experienced, Boosted, Blood Draw Only
n=121 Participants
Group 4 Vaccinia Experienced
1 booster dose of MVA-BN in prior study (POX-MVA-005) Blood draw, Screening Visit only (POX-MVA-023)
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
27.7 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
172 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
ELISA Long-Term Persistence
|
23.33 Titer
n=5 Participants
|
6.20 Titer
n=7 Participants
|
134.65 Titer
n=5 Participants
|
31.52 Titer
n=4 Participants
|
|
PRNT Long-Term Persistence
|
1.26 Titer
n=5 Participants
|
1.05 Titer
n=7 Participants
|
10.28 Titer
n=5 Participants
|
2.75 Titer
n=4 Participants
|
PRIMARY outcome
Timeframe: within 4 weeksPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an 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 booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Individual Peak Booster Rate by ELISA (Percentage of Participants)
|
100.0 percentage of subjects
Interval 95.2 to 100.0
|
100.0 percentage of subjects
Interval 95.3 to 100.0
|
SECONDARY outcome
Timeframe: within 26 weeksPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an 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. Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Booster Rate by ELISA (Percentage of Participants)
Week 1
|
100.0 percentage of subjects
Interval 95.2 to 100.0
|
98.7 percentage of subjects
Interval 93.0 to 100.0
|
|
Booster Rate by ELISA (Percentage of Participants)
Week 2
|
100.0 percentage of subjects
Interval 95.2 to 100.0
|
100.0 percentage of subjects
Interval 95.3 to 100.0
|
|
Booster Rate by ELISA (Percentage of Participants)
Week 4
|
100.0 percentage of subjects
Interval 95.1 to 100.0
|
100.0 percentage of subjects
Interval 95.3 to 100.0
|
|
Booster Rate by ELISA (Percentage of Participants)
Week 26
|
98.6 percentage of subjects
Interval 92.4 to 100.0
|
100.0 percentage of subjects
Interval 95.3 to 100.0
|
SECONDARY outcome
Timeframe: within 26 weeksPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
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 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
ELISA GMT
Screening
|
24.23 Titer
Interval 15.2 to 38.62
|
5.89 Titer
Interval 3.63 to 9.57
|
|
ELISA GMT
Week 1
|
737.93 Titer
Interval 597.37 to 911.58
|
490.33 Titer
Interval 368.48 to 652.46
|
|
ELISA GMT
Week 2
|
1688.20 Titer
Interval 1381.55 to 2062.91
|
1608.89 Titer
Interval 1285.9 to 2013.0
|
|
ELISA GMT
Week 4
|
1255.21 Titer
Interval 1029.02 to 1531.13
|
1210.59 Titer
Interval 974.01 to 1504.62
|
|
ELISA GMT
Individual peak
|
1821.57 Titer
Interval 1496.13 to 2217.8
|
1723.74 Titer
Interval 1376.87 to 2158.01
|
|
ELISA GMT
Week 26
|
461.78 Titer
Interval 381.16 to 559.46
|
382.91 Titer
Interval 301.66 to 486.03
|
SECONDARY outcome
Timeframe: within 26 weeksPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Booster rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual Peak booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Booster Rate by PRNT (Percentage of Participants)
Week 1
|
92.0 percentage of subjects
Interval 83.4 to 97.0
|
85.7 percentage of subjects
Interval 75.9 to 92.6
|
|
Booster Rate by PRNT (Percentage of Participants)
Week 2
|
98.7 percentage of subjects
Interval 92.8 to 100.0
|
96.1 percentage of subjects
Interval 89.0 to 99.2
|
|
Booster Rate by PRNT (Percentage of Participants)
Week 4
|
94.6 percentage of subjects
Interval 86.7 to 98.5
|
90.9 percentage of subjects
Interval 82.2 to 96.3
|
|
Booster Rate by PRNT (Percentage of Participants)
Individual peak
|
98.7 percentage of subjects
Interval 92.8 to 100.0
|
98.7 percentage of subjects
Interval 93.0 to 100.0
|
|
Booster Rate by PRNT (Percentage of Participants)
Week 26
|
88.7 percentage of subjects
Interval 79.0 to 95.0
|
76.6 percentage of subjects
Interval 65.6 to 85.5
|
SECONDARY outcome
Timeframe: within 26 weeksPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
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 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
PRNT GMT
Screening
|
1.23 Titer
Interval 0.99 to 1.52
|
1.06 Titer
Interval 0.95 to 1.18
|
|
PRNT GMT
Week 1
|
53.61 Titer
Interval 37.05 to 77.59
|
28.58 Titer
Interval 18.56 to 43.99
|
|
PRNT GMT
Week 2
|
125.26 Titer
Interval 89.51 to 175.27
|
80.69 Titer
Interval 54.37 to 119.75
|
|
PRNT GMT
Week 4
|
64.26 Titer
Interval 43.19 to 95.61
|
48.96 Titer
Interval 31.72 to 75.57
|
|
PRNT GMT
Individual Peak
|
165.97 Titer
Interval 124.21 to 221.77
|
116.79 Titer
Interval 82.42 to 165.49
|
|
PRNT GMT
Week 26
|
49.29 Titer
Interval 32.4 to 74.98
|
25.62 Titer
Interval 15.84 to 41.44
|
SECONDARY outcome
Timeframe: within 26 weeksPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Correlation PRNT vs ELISA Titers
Week 1
|
0.591 Pearson correlation coefficient
|
0.690 Pearson correlation coefficient
|
|
Correlation PRNT vs ELISA Titers
Week 2
|
0.491 Pearson correlation coefficient
|
0.655 Pearson correlation coefficient
|
|
Correlation PRNT vs ELISA Titers
Week 4
|
0.476 Pearson correlation coefficient
|
0.592 Pearson correlation coefficient
|
|
Correlation PRNT vs ELISA Titers
Week 26
|
0.568 Pearson correlation coefficient
|
0.550 Pearson correlation coefficient
|
SECONDARY outcome
Timeframe: within 26 weeksPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
Number of participants with Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Number of Participants With Related Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
Number of participants with any, grade \>=3, and related non-serious unsolicited adverse events
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Number of Participants With Unsolicited Non-serious Adverse Events
Any event
|
40 Participants
|
38 Participants
|
|
Number of Participants With Unsolicited Non-serious Adverse Events
Any event with intensity >= Grade 3
|
4 Participants
|
5 Participants
|
|
Number of Participants With Unsolicited Non-serious Adverse Events
Any event assessed as related to vaccine
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: within 29 days after vaccinationPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
Number of participants with Grade \>=3 Unsolicited Adverse Event probably, possibly, or definitely related to the study vaccine
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Number of Participants With Related Grade >= 3 Unsolicited Adverse Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 8 days after vaccinationPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
Number of participants with and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritis). Percentages based on subjects with a completed diary card.
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Number of Participants With Solicited Local Adverse Events
Induration: Grade >=3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Pruritis: Any
|
30 Participants
|
36 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Pain: Any
|
58 Participants
|
64 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Pain: Grade >=3
|
1 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Erythema: Any
|
60 Participants
|
65 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Erythema: Grade >=3
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Swelling: Any
|
51 Participants
|
48 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Swelling: Grade >=3
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Induration: Any
|
58 Participants
|
58 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Pruritis: Grade >=3
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 8 days after vaccinationPopulation: Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
Number of participants with solicited general AEs (body temperature increased, headache, myalgia, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with a completed diary card.
Outcome measures
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 Participants
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 Participants
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Number of Participants With Solicited General Adverse Events
Nausea: Any
|
6 Participants
|
12 Participants
|
|
Number of Participants With Solicited General Adverse Events
Body temperature increased: Any
|
3 Participants
|
4 Participants
|
|
Number of Participants With Solicited General Adverse Events
Body temperature increased: Grade >=3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited General Adverse Events
Body temperature increased: Related Grade >=3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited General Adverse Events
Headache: Any
|
19 Participants
|
25 Participants
|
|
Number of Participants With Solicited General Adverse Events
Headache: Grade >=3
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited General Adverse Events
Headache: Related Grade >=3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited General Adverse Events
Myalgia: Any
|
17 Participants
|
19 Participants
|
|
Number of Participants With Solicited General Adverse Events
Myalgia: Grade >=3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited General Adverse Events
Myalgia: Related Grade >=3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited General Adverse Events
Nausea: Grade >=3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited General Adverse Events
Nausea: Related Grade >=3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited General Adverse Events
Fatigue: Any
|
22 Participants
|
27 Participants
|
|
Number of Participants With Solicited General Adverse Events
Fatigue: Grade >=3
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited General Adverse Events
Fatigue: Related Grade >=3
|
2 Participants
|
0 Participants
|
Adverse Events
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 participants at risk
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 participants at risk
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
0.00%
0/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Injury, poisoning and procedural complications
Concussion
|
1.3%
1/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
0.00%
0/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
Other adverse events
| Measure |
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose
n=75 participants at risk
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
n=77 participants at risk
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005)
1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8\_TCID50
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
3.9%
3/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Cardiac disorders
Palpitations
|
2.7%
2/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
1.3%
1/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
2.6%
2/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Gastrointestinal disorders
Toothache
|
2.7%
2/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
0.00%
0/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
General disorders
Chills
|
0.00%
0/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
2.6%
2/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
General disorders
Injection site irritation
|
2.7%
2/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
0.00%
0/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
General disorders
Injection site warmth
|
4.0%
3/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
3.9%
3/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Infections and infestations
Nasopharyngitis
|
26.7%
20/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
11.7%
9/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
2.6%
2/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Nervous system disorders
Headache
|
6.7%
5/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
9.1%
7/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Nervous system disorders
Migraine
|
2.7%
2/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
1.3%
1/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
2/75 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
1.3%
1/77 • 7 months
AEs only collected for subjects that received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place