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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00686582
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : February 18, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Bavarian Nordic

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Smallpox
Interventions Biological: IMVAMUNE
Procedure: Blood Draw Only
Enrollment 304
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose Vaccinia Experienced, Boosted, Blood Draw Only
Hide Arm/Group Description

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

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

Group 4 Vaccinia Experienced

1 booster dose of MVA-BN in prior study (POX-MVA-005) Blood draw, Screening Visit only (POX-MVA-023)

Period Title: Overall Study
Started [1] 92 91 121
Booster Vaccination 75 77 0
Completed [2] 74 77 121
Not Completed 18 14 0
[1]
Blood Draw for Antibody Persistence 2 yrs after study POX-MVA-005
[2]
Active trial phase
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose Vaccinia Experienced, Boosted, Blood Draw Only Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 92 91 121 304
Hide Baseline Analysis Population Description
Persistence Set i.e. subjects previously vaccinated in study POX-MVA-005 with a blood draw at the screening visit of study POX-MVA-023
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 91 participants 121 participants 304 participants
27.7  (5.8) 27.7  (4.5) 44.9  (6.6) 34.6  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 91 participants 121 participants 304 participants
Female
50
  54.3%
55
  60.4%
67
  55.4%
172
  56.6%
Male
42
  45.7%
36
  39.6%
54
  44.6%
132
  43.4%
ELISA Long-Term Persistence   [1] 
Geometric Mean (Full Range)
Unit of measure:  Titer
Number Analyzed 92 participants 91 participants 121 participants 304 participants
23.33
(1 to 1877)
6.20
(1 to 262)
134.65
(1 to 1103)
31.52
(1 to 1877)
[1]
Measure Description:

Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) at the Screening Visit (2 years after one or two doses of MVA-BN in POX-MVA-005) are considered long-term immunogenicity outcomes from previous study. Titers below the detection limit are included with a value of '1'.

Total Column: Pooled data is of limited relevance due to different precondition (naive vs experienced) / treatment (2 doses vs 1 dose of MVA-BN) in POX-MVA-005.

PRNT Long-Term Persistence   [1] 
Geometric Mean (Full Range)
Unit of measure:  Titer
Number Analyzed 92 participants 91 participants 121 participants 304 participants
1.26
(1 to 226)
1.05
(1 to 67)
10.28
(1 to 4382)
2.75
(1 to 4382)
[1]
Measure Description:

Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT) at the Screening Visit (2 years after one or two doses of MVA-BN in POX-MVA-005) are considered long-term immunogenicity outcomes from previous study. Titers below the detection limit are included with a value of '1'.

Total Column: Pooled data is of limited relevance due to different precondition (naive vs experienced) / treatment (2 doses vs 1 dose of MVA-BN) in POX-MVA-005.

1.Primary Outcome
Title Individual Peak Booster Rate by ELISA (Percentage of Participants)
Hide Description 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.
Time Frame within 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
100.0
(95.2 to 100.0)
100.0
(95.3 to 100.0)
2.Secondary Outcome
Title Booster Rate by ELISA (Percentage of Participants)
Hide Description 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.
Time Frame within 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 1 Number Analyzed 75 participants 77 participants
100.0
(95.2 to 100.0)
98.7
(93.0 to 100.0)
Week 2 Number Analyzed 75 participants 77 participants
100.0
(95.2 to 100.0)
100.0
(95.3 to 100.0)
Week 4 Number Analyzed 74 participants 77 participants
100.0
(95.1 to 100.0)
100.0
(95.3 to 100.0)
Week 26 Number Analyzed 71 participants 77 participants
98.6
(92.4 to 100.0)
100.0
(95.3 to 100.0)
3.Secondary Outcome
Title ELISA GMT
Hide Description 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'.
Time Frame within 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Screening
24.23
(15.20 to 38.62)
5.89
(3.63 to 9.57)
Week 1
737.93
(597.37 to 911.58)
490.33
(368.48 to 652.46)
Week 2
1688.20
(1381.55 to 2062.91)
1608.89
(1285.90 to 2013.00)
Week 4
1255.21
(1029.02 to 1531.13)
1210.59
(974.01 to 1504.62)
Individual peak
1821.57
(1496.13 to 2217.80)
1723.74
(1376.87 to 2158.01)
Week 26
461.78
(381.16 to 559.46)
382.91
(301.66 to 486.03)
4.Secondary Outcome
Title Booster Rate by PRNT (Percentage of Participants)
Hide Description

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.

Time Frame within 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 1 Number Analyzed 75 participants 77 participants
92.0
(83.4 to 97.0)
85.7
(75.9 to 92.6)
Week 2 Number Analyzed 75 participants 77 participants
98.7
(92.8 to 100.0)
96.1
(89.0 to 99.2)
Week 4 Number Analyzed 74 participants 77 participants
94.6
(86.7 to 98.5)
90.9
(82.2 to 96.3)
Individual peak Number Analyzed 75 participants 77 participants
98.7
(92.8 to 100.0)
98.7
(93.0 to 100.0)
Week 26 Number Analyzed 71 participants 77 participants
88.7
(79.0 to 95.0)
76.6
(65.6 to 85.5)
5.Secondary Outcome
Title PRNT GMT
Hide Description 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'.
Time Frame within 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Screening
1.23
(0.99 to 1.52)
1.06
(0.95 to 1.18)
Week 1
53.61
(37.05 to 77.59)
28.58
(18.56 to 43.99)
Week 2
125.26
(89.51 to 175.27)
80.69
(54.37 to 119.75)
Week 4
64.26
(43.19 to 95.61)
48.96
(31.72 to 75.57)
Individual Peak
165.97
(124.21 to 221.77)
116.79
(82.42 to 165.49)
Week 26
49.29
(32.40 to 74.98)
25.62
(15.84 to 41.44)
6.Secondary Outcome
Title Correlation PRNT vs ELISA Titers
Hide Description Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Time Frame within 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Pearson correlation coefficient
Week 1 0.591 0.690
Week 2 0.491 0.655
Week 4 0.476 0.592
Week 26 0.568 0.550
7.Secondary Outcome
Title Number of Participants With Related Serious Adverse Events
Hide Description Number of participants with Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine
Time Frame within 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Unsolicited Non-serious Adverse Events
Hide Description Number of participants with any, grade >=3, and related non-serious unsolicited adverse events
Time Frame within 29 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Count of Participants
Unit of Measure: Participants
Any event
40
  53.3%
38
  49.4%
Any event with intensity >= Grade 3
4
   5.3%
5
   6.5%
Any event assessed as related to vaccine
11
  14.7%
9
  11.7%
9.Secondary Outcome
Title Number of Participants With Related Grade >= 3 Unsolicited Adverse Events
Hide Description Number of participants with Grade >=3 Unsolicited Adverse Event probably, possibly, or definitely related to the study vaccine
Time Frame within 29 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.3%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Solicited Local Adverse Events
Hide Description 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.
Time Frame within 8 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Count of Participants
Unit of Measure: Participants
Pain: Any
58
  77.3%
64
  83.1%
Pain: Grade >=3
1
   1.3%
3
   3.9%
Erythema: Any
60
  80.0%
65
  84.4%
Erythema: Grade >=3
0
   0.0%
2
   2.6%
Swelling: Any
51
  68.0%
48
  62.3%
Swelling: Grade >=3
0
   0.0%
2
   2.6%
Induration: Any
58
  77.3%
58
  75.3%
Induration: Grade >=3
0
   0.0%
1
   1.3%
Pruritis: Any
30
  40.0%
36
  46.8%
Pruritis: Grade >=3
1
   1.3%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Solicited General Adverse Events
Hide Description 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.
Time Frame within 8 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 75 77
Measure Type: Count of Participants
Unit of Measure: Participants
Body temperature increased: Any
3
   4.0%
4
   5.2%
Body temperature increased: Grade >=3
0
   0.0%
0
   0.0%
Body temperature increased: Related Grade >=3
0
   0.0%
0
   0.0%
Headache: Any
19
  25.3%
25
  32.5%
Headache: Grade >=3
2
   2.7%
1
   1.3%
Headache: Related Grade >=3
1
   1.3%
1
   1.3%
Myalgia: Any
17
  22.7%
19
  24.7%
Myalgia: Grade >=3
1
   1.3%
1
   1.3%
Myalgia: Related Grade >=3
1
   1.3%
0
   0.0%
Nausea: Any
6
   8.0%
12
  15.6%
Nausea: Grade >=3
0
   0.0%
0
   0.0%
Nausea: Related Grade >=3
0
   0.0%
0
   0.0%
Fatigue: Any
22
  29.3%
27
  35.1%
Fatigue: Grade >=3
2
   2.7%
0
   0.0%
Fatigue: Related Grade >=3
2
   2.7%
0
   0.0%
Time Frame 7 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Hide Arm/Group Description

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

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

All-Cause Mortality
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/77 (0.00%) 
Hide Serious Adverse Events
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   2/75 (2.67%)   0/77 (0.00%) 
Infections and infestations     
Gastroenteritis  1  1/75 (1.33%)  0/77 (0.00%) 
Injury, poisoning and procedural complications     
Concussion  1  1/75 (1.33%)  0/77 (0.00%) 
1
Term from vocabulary, MedDRA 11.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   35/75 (46.67%)   25/77 (32.47%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/75 (0.00%)  3/77 (3.90%) 
Cardiac disorders     
Palpitations  1  2/75 (2.67%)  1/77 (1.30%) 
Gastrointestinal disorders     
Aphthous stomatitis  1  0/75 (0.00%)  2/77 (2.60%) 
Toothache  1  2/75 (2.67%)  0/77 (0.00%) 
General disorders     
Chills  1  0/75 (0.00%)  2/77 (2.60%) 
Injection site irritation  1  2/75 (2.67%)  0/77 (0.00%) 
Injection site warmth  1  3/75 (4.00%)  3/77 (3.90%) 
Infections and infestations     
Nasopharyngitis  1  20/75 (26.67%)  9/77 (11.69%) 
Injury, poisoning and procedural complications     
Limb injury  1  0/75 (0.00%)  2/77 (2.60%) 
Nervous system disorders     
Headache  1  5/75 (6.67%)  7/77 (9.09%) 
Migraine  1  2/75 (2.67%)  1/77 (1.30%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  2/75 (2.67%)  1/77 (1.30%) 
1
Term from vocabulary, MedDRA 11.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Program Lead, Clinical Operations
Organization: Bavarian Nordic A/S
Phone: +45 3326 ext 8383
EMail: info@bavarian-nordic.com
Layout table for additonal information
Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00686582    
Other Study ID Numbers: POX-MVA-023
EudraCT-No.2007-006297-28
DMID 08-0018
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: December 19, 2018
Results First Posted: February 18, 2019
Last Update Posted: March 13, 2019