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Trial record 2 of 2 for:    pox-mva-005

A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects

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: NCT00316524
Recruitment Status : Completed
First Posted : April 21, 2006
Results First Posted : January 9, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Bavarian Nordic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Smallpox
Interventions Biological: MVA-BN® (IMVAMUNE)
Biological: Placebo
Enrollment 745
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: 2 x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: Two x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50) vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer).

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID50).
Period Title: Overall Study
Started [1] 183 181 181 200
Completed [2] 175 173 175 200
Not Completed 8 8 6 0
[1]
Vaccinated
[2]
Active Trial Phase
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced Total
Hide Arm/Group Description vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50) vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50) Total of all reporting groups
Overall Number of Baseline Participants 183 181 181 200 745
Hide Baseline Analysis Population Description
Safety Dataset
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 183 participants 181 participants 181 participants 200 participants 745 participants
25.3  (4.98) 25.4  (4.38) 26.0  (5.1) 41.5  (7.59) 29.8  (9.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 181 participants 181 participants 200 participants 745 participants
Female
97
  53.0%
112
  61.9%
107
  59.1%
115
  57.5%
431
  57.9%
Male
86
  47.0%
69
  38.1%
74
  40.9%
85
  42.5%
314
  42.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnic group Number Analyzed 183 participants 181 participants 181 participants 200 participants 745 participants
Caucasian
178
  97.3%
176
  97.2%
177
  97.8%
198
  99.0%
729
  97.9%
Asian
1
   0.5%
2
   1.1%
1
   0.6%
0
   0.0%
4
   0.5%
Black
0
   0.0%
1
   0.6%
0
   0.0%
1
   0.5%
2
   0.3%
Arabic
2
   1.1%
1
   0.6%
1
   0.6%
0
   0.0%
4
   0.5%
Other
2
   1.1%
1
   0.6%
2
   1.1%
1
   0.5%
6
   0.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 183 participants 181 participants 181 participants 200 participants 745 participants
183 181 181 200 745
1.Primary Outcome
Title Percentage of Participants With Seroconversion by ELISA
Hide Description 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. Percentages based on number of subjects with data available.
Time Frame 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive GP 3: Two x Placebo, s.c., Vaccinia Naive GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:

vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID)

MVA-BN® (IMVAMUNE): 1x 10E8_TCID50

vaccinia naive subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID), followed by one subcutaneous vaccination Placebo (0.5ml Tris Buffer)

MVA-BN® (IMVAMUNE): 1x 10E8_TCID50

Placebo: Tris-Buffer

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID)

MVA-BN® (IMVAMUNE): 1x 10E8_TCID50

Overall Number of Participants Analyzed 176 174 175 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
98.9
(96.0 to 99.9)
82.2
(75.7 to 87.6)
3.4
(1.3 to 7.3)
95.5
(91.6 to 97.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive, GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin to show that Group 4 (vaccinia experienced subjects receiving a single vaccination) is non-inferior to Group 1 (vaccinia naive subjects receiving 2 vaccinations) in terms of seroconversion rate 2 weeks after the last vaccination was predefined as -5% for the difference in seroconversion rates
Method of Estimation Estimation Parameter Difference in seroconversion rates (%)
Estimated Value -3.4
Confidence Interval (1-Sided) 97.5%
-7.36
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With ECG Changes
Hide Description Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6).
Time Frame within 2 weeks after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety dataset
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 183 181 181 200
Measure Type: Number
Unit of Measure: participants
SCR : Supraventricular arrhytmia 0 0 0 0
SCR : Ventricular arrhythmia 0 0 0 0
SCR : AV block (PQ time >0.20 sec) 1st degree 0 0 1 1
SCR : Right bundle branch block - incomplete 10 18 4 1
SCR : ST elevation 5 1 4 1
SCR : ST depression 0 1 0 1
SCR : T inversion - pathological 42 54 50 48
SCR : T inversion - other 14 19 22 16
SCR : Low voltage 0 0 0 1
SCR : Other non-specific changes 23 23 26 5
SCR : Bradycardia 30 28 30 6
SCR : Arrhythmia 4 3 8 1
SCR : Repolarisation 3 3 3 0
SCR : Q-Abnormalities 1 1 0 4
SCR : Tall T-waves 0 0 0 0
Week 2 : Supraventricular arrhytmia 0 1 0 0
Week 2 : Ventricular arrhythmia 0 1 1 0
Week 2 : AV block (PQ time >0.20 sec) 1st degree 0 0 1 1
Week 2 : Right bundle branch block - incomplete 9 17 15 15
Week 2 : ST elevation 3 1 2 0
Week 2 : ST depression 0 1 1 1
Week 2 : T inversion - pathological 34 46 40 31
Week 2 : T inversion - other 11 9 10 7
Week 2 : Low voltage 0 0 0 0
Week 2 : Other non-specific changes 34 29 34 14
Week 2 : Bradycardia 31 25 33 6
Week 2 : Arrhythmia 4 4 2 5
Week 2 : Repolarisation 1 3 2 1
Week 2 : Q-Abnormalities 0 3 1 4
Week 2 : Tall T-waves 1 3 0 0
Week 6 : Supraventricular arrhytmia 1 1 0 NA [1] 
Week 6 : Ventricular arrhythmia 0 0 0 NA [1] 
Week 6 : AV block (PQ time >0.20 sec) 1st degree 2 0 1 NA [1] 
Week 6 : Right bundle branch block - incomplete 10 20 12 NA [1] 
Week 6 : ST elevation 1 3 1 NA [1] 
Week 6 : ST depression 1 0 0 NA [1] 
Week 6 : T inversion - pathological 28 37 39 NA [1] 
Week 6 : T inversion - other 3 5 4 NA [1] 
Week 6 : Low voltage 0 0 0 NA [1] 
Week 6 : Other non-specific changes 35 35 33 NA [1] 
Week 6 : Bradycardia 30 23 28 NA [1] 
Week 6 : Arrhythmia 4 4 2 NA [1] 
Week 6 : Repolarisation 2 3 7 NA [1] 
Week 6 : Q-Abnormalities 1 0 1 NA [1] 
Week 6 : Tall T-waves 1 1 2 NA [1] 
[1]
Visit not applicable to Group 4 subjects
3.Primary Outcome
Title Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI])
Hide Description Occurrence and relationship of any other cardiac symptom at any time during the study
Time Frame within 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety dataset
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 183 181 181 200
Measure Type: Number
Unit of Measure: events
Sinus tachycardia : related 0 0 0 0
Sinus tachycardia : unrelated 1 1 0 0
Tachycardia : related 0 1 0 1
Tachycardia : unrelated 1 0 0 1
Palpitations : related 0 1 0 2
Palpitations : unrelated 1 1 1 3
Mild pericardial effusion : related 0 0 0 0
Mild pericardial effusion : unrelated 0 0 0 1
4.Secondary Outcome
Title Percentage of Participants With Seroconversion by ELISA
Hide Description 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. Percentages based on number of subjects with data available.
Time Frame 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (includes subjects with data available 4 weeks following the last vaccination)
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 178 175 177 199
Measure Type: Number
Unit of Measure: percentage of subjects
98.9 72.0 2.8 93.0
5.Secondary Outcome
Title Percentage of Participants With Seroconversion by PRNT
Hide Description Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 176 174 175 200
Measure Type: Number
Unit of Measure: percentage of subjects
89.2 56.3 0.0 78.5
6.Secondary Outcome
Title Percentage of Participants With Seroconversion by PRNT
Hide Description Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (includes subjects with data available 4 weeks following the last vaccination)
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 178 175 177 199
Measure Type: Number
Unit of Measure: percentage of subjects
86.0 47.4 0.0 69.8
7.Secondary Outcome
Title Number of Participants With Related Serious Adverse Events
Hide Description Number of participants with any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study
Time Frame within 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety dataset
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 183 181 181 200
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Solicited Local Adverse Events
Hide Description Number of participants with solicited local AEs (pain, erythema, swelling and induration) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card.
Time Frame within 8 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety dataset
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 182 179 179 200
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site pain
166
  91.2%
155
  86.6%
37
  20.7%
167
  83.5%
Injection site erythema
166
  91.2%
146
  81.6%
39
  21.8%
169
  84.5%
Injection site swelling
149
  81.9%
103
  57.5%
10
   5.6%
149
  74.5%
Injection site induration
162
  89.0%
146
  81.6%
5
   2.8%
155
  77.5%
9.Secondary Outcome
Title Number of Participants With Solicited General Adverse Events
Hide Description Number of participants with solicited systemic/general AEs (body temperature increased, headache, myalgia, nausea, and fatigue) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card.
Time Frame within 8 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety dataset
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 182 179 179 200
Measure Type: Count of Participants
Unit of Measure: Participants
Body temperature increased
18
   9.9%
21
  11.7%
10
   5.6%
10
   5.0%
Headache
60
  33.0%
84
  46.9%
49
  27.4%
53
  26.5%
Myalgia
29
  15.9%
22
  12.3%
20
  11.2%
42
  21.0%
Nausea
17
   9.3%
22
  12.3%
13
   7.3%
18
   9.0%
Fatigue
68
  37.4%
59
  33.0%
55
  30.7%
78
  39.0%
10.Secondary Outcome
Title Number of Participants With Related Grade>=3 Adverse Events
Hide Description Number of participants with any Grade >=3 AE probably, possibly, or definitely related to the study vaccine within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Pooled solicited (local and general) and unsolicited AEs.
Time Frame within 4 weeks after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety dataset
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 183 181 181 200
Measure Type: Count of Participants
Unit of Measure: Participants
10
   5.5%
5
   2.8%
5
   2.8%
15
   7.5%
11.Secondary Outcome
Title Number of Participants With Unsolicited Non-serious Adverse Events
Hide Description Number of participants with non-serious unsolicited AEs within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0).
Time Frame within 4 weeks after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety dataset
Arm/Group Title Group 1: 2x MVA-BN® s.c., Vaccinia Naive Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive Group 3: 2x Placebo, s.c., Vaccinia Naive Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description:
vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one subcutaneous vaccination Placebo (0.5mL Tris Buffer)

vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)

Placebo: Tris-Buffer

vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50)
Overall Number of Participants Analyzed 183 181 181 200
Measure Type: Count of Participants
Unit of Measure: Participants
113
  61.7%
106
  58.6%
78
  43.1%
99
  49.5%
Time Frame 32 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive GP 3: Two x Placebo, s.c., Vaccinia Naive GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced
Hide Arm/Group Description

vaccinia naive subjects receiving two subcutanenous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID)

MVA-BN® (IMVAMUNE): 1x 10E8_TCID50

vaccinica naive subjects receiving one vaccination with 0.5ml MVA-BN® IMVAMUNE(1x10E08 TCID), followed by one vaccination Placebo (0.5ml Tris Buffer)

MVA-BN® (IMVAMUNE): 1x 10E8_TCID50

Placebo: Tris-Buffer

vaccinia naive subjects, receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer).

Placebo: Tris-Buffer

vaccinia experienced subjects, receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID).

MVA-BN® (IMVAMUNE): 1x 10E8_TCID50

All-Cause Mortality
GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive GP 3: Two x Placebo, s.c., Vaccinia Naive GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/183 (0.00%)      0/181 (0.00%)      0/181 (0.00%)      0/200 (0.00%)    
Hide Serious Adverse Events
GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive GP 3: Two x Placebo, s.c., Vaccinia Naive GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/183 (1.64%)      3/181 (1.66%)      5/181 (2.76%)      1/200 (0.50%)    
Endocrine disorders         
Thyroid cyst  1  0/183 (0.00%)  0 0/181 (0.00%)  0 1/181 (0.55%)  1 0/200 (0.00%)  0
Immune system disorders         
Sarcoidosis  1  1/183 (0.55%)  1 0/181 (0.00%)  0 0/181 (0.00%)  0 0/200 (0.00%)  0
Infections and infestations         
Gastroenteritis salmonella  1  0/183 (0.00%)  0 0/181 (0.00%)  0 1/181 (0.55%)  1 0/200 (0.00%)  0
Injury, poisoning and procedural complications         
Lower limb fracture  1  0/183 (0.00%)  0 0/181 (0.00%)  0 1/181 (0.55%)  1 0/200 (0.00%)  0
Tendon injury  1  0/183 (0.00%)  0 1/181 (0.55%)  1 0/181 (0.00%)  0 0/200 (0.00%)  0
Tendon rupture  1  0/183 (0.00%)  0 0/181 (0.00%)  0 0/181 (0.00%)  0 1/200 (0.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign neoplasm of thyroid gland  1  0/183 (0.00%)  0 0/181 (0.00%)  0 1/181 (0.55%)  1 0/200 (0.00%)  0
Colon cancer  1  0/183 (0.00%)  0 0/181 (0.00%)  0 1/181 (0.55%)  1 0/200 (0.00%)  0
Nervous system disorders         
Hemiparesis  1  0/183 (0.00%)  0 1/181 (0.55%)  1 0/181 (0.00%)  0 0/200 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Pregnancy  1  0/183 (0.00%)  0 1/181 (0.55%)  1 0/181 (0.00%)  0 0/200 (0.00%)  0
Psychiatric disorders         
Depression  1  0/183 (0.00%)  0 0/181 (0.00%)  0 1/181 (0.55%)  1 0/200 (0.00%)  0
Mental disorder  1  1/183 (0.55%)  1 0/181 (0.00%)  0 0/181 (0.00%)  0 0/200 (0.00%)  0
Surgical and medical procedures         
Thyroidectomy  1  0/183 (0.00%)  0 0/181 (0.00%)  0 1/181 (0.55%)  1 0/200 (0.00%)  0
Tonsillectomy  1  1/183 (0.55%)  1 0/181 (0.00%)  0 0/181 (0.00%)  0 0/200 (0.00%)  0
1
Term from vocabulary, MedDRA 7.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive GP 3: Two x Placebo, s.c., Vaccinia Naive GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/183 (49.73%)      88/181 (48.62%)      54/181 (29.83%)      73/200 (36.50%)    
Blood and lymphatic system disorders         
Lymphadenopaty  1  4/183 (2.19%)  5 4/181 (2.21%)  4 2/181 (1.10%)  2 4/200 (2.00%)  4
Gastrointestinal disorders         
Abdominal pain upper  1  1/183 (0.55%)  1 1/181 (0.55%)  1 4/181 (2.21%)  4 0/200 (0.00%)  0
Diarrhoea  1  3/183 (1.64%)  3 4/181 (2.21%)  4 3/181 (1.66%)  3 6/200 (3.00%)  6
General disorders         
Injection site pruritus  1  43/183 (23.50%)  61 36/181 (19.89%)  37 4/181 (2.21%)  4 49/200 (24.50%)  49
Injection site hematoma  1  6/183 (3.28%)  6 9/181 (4.97%)  9 5/181 (2.76%)  5 4/200 (2.00%)  4
Injection site warmth  1  9/183 (4.92%)  10 5/181 (2.76%)  5 0/181 (0.00%)  0 8/200 (4.00%)  8
Injection site discoloration  1  1/183 (0.55%)  1 4/181 (2.21%)  4 0/181 (0.00%)  0 0/200 (0.00%)  0
Infections and infestations         
Bronchitis  1  3/183 (1.64%)  3 4/181 (2.21%)  4 2/181 (1.10%)  2 1/200 (0.50%)  1
Nasopharyngitis  1  42/183 (22.95%)  45 20/181 (11.05%)  20 26/181 (14.36%)  28 4/200 (2.00%)  4
Rhinitis  1  3/183 (1.64%)  3 1/181 (0.55%)  1 4/181 (2.21%)  4 1/200 (0.50%)  1
Tonsilitis  1  4/183 (2.19%)  4 5/181 (2.76%)  5 1/181 (0.55%)  1 0/200 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  4/183 (2.19%)  4 1/181 (0.55%)  1 5/181 (2.76%)  5 2/200 (1.00%)  2
Nervous system disorders         
Headache  1  10/183 (5.46%)  11 16/181 (8.84%)  17 11/181 (6.08%)  11 6/200 (3.00%)  6
Dizziness  1  2/183 (1.09%)  3 7/181 (3.87%)  7 2/181 (1.10%)  3 4/200 (2.00%)  4
Respiratory, thoracic and mediastinal disorders         
Cough  1  5/183 (2.73%)  5 1/181 (0.55%)  1 3/181 (1.66%)  3 0/200 (0.00%)  0
Pharyngolaryngeal pain  1  11/183 (6.01%)  11 9/181 (4.97%)  9 8/181 (4.42%)  9 4/200 (2.00%)  4
Vascular disorders         
Hot flush  1  0/183 (0.00%)  0 0/181 (0.00%)  0 0/181 (0.00%)  0 4/200 (2.00%)  4
1
Term from vocabulary, MedDRA 7.1
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
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Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00316524    
Other Study ID Numbers: POX-MVA-005
DMID 05-0128
EudraCT No. 2005-001781-14
First Submitted: April 19, 2006
First Posted: April 21, 2006
Results First Submitted: December 19, 2018
Results First Posted: January 9, 2019
Last Update Posted: March 6, 2019