Trial Outcomes & Findings for Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection (NCT NCT02038881)
NCT ID: NCT02038881
Last Updated: 2020-04-02
Results Overview
Occurrence, relationship and intensity of any serious AE (SAE)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
within 75 weeks
Results posted on
2020-04-02
Participant Flow
Subjects were screened and enrolled at 12 sites in the US
Participant milestones
| Measure |
Group 1 (Standard Regimen)
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
29
|
31
|
|
Overall Study
COMPLETED
|
24
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1 (Standard Regimen)
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
incarcerated
|
1
|
0
|
0
|
Baseline Characteristics
Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection
Baseline characteristics by cohort
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 6.67 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 5.43 • n=5 Participants
|
35 years
STANDARD_DEVIATION 6.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Oriental/Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
29 participants
n=7 Participants
|
31 participants
n=5 Participants
|
87 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 75 weeksPopulation: Full Analysis Set
Occurrence, relationship and intensity of any serious AE (SAE)
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Number of Participants With SAEs
Any SAE
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With SAEs
Any SAE with intensity >= Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With SAEs
Any SAE assessed as related to vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 75 weeksPopulation: Full Analysis Set
Occurrence, relationship to the trial vaccine, and intensity of any adverse event of special interest (AESI)
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Number of Participants With AESIs
Any AESI
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With AESIs
Any AESI with intensity >= Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With AESIs
Any AESI assessed as related to vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Full Analysis Set
Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited and unsolicited AEs.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Number of Participants With Related Grade >=3 Adverse Events
|
4 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Full Analysis Set
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Possible
|
1 events
|
1 events
|
0 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Probable
|
0 events
|
0 events
|
1 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Unrelated/None
|
4 events
|
4 events
|
13 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Unlikely
|
1 events
|
2 events
|
1 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Definite
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Full Analysis Set
Occurrence of unsolicited non-serious AEs by Intensity
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Mild
|
4 events
|
7 events
|
9 events
|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Moderate
|
1 events
|
0 events
|
6 events
|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Severe
|
1 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: within 8 days after any vaccinationPopulation: Full Analysis Set
Number of participants with solicited local AEs (redness, swelling, induration, pruritus, and pain) by intensity. Percentages based on subjects with at least one completed diary card. \[Injection site erythema, injection site swelling and injection site induration--all sizes measured in diameter with max severity of: 0=0, 1 = \<30 mm, 2 = ≥30 - \<100 mm, 3 = ≥100 mm. Injection site pruritus: 0=absent, 1=mild, 2=moderate, 3=severe. Injection site pain: 0=absent, 1=painful to touch, 2=painful when limb is moved, 3=spontaneously painful/prevents normal activity.\]
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Pain, Grade 1
|
5 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Pain, Grade 2
|
10 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Pain, Grade 3
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Erythema, Grade 1
|
7 Participants
|
11 Participants
|
15 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Erythema, Grade 2
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Erythema, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Swelling, Grade 1
|
9 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Swelling, Grade 2
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Swelling, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Induration, Grade 1
|
7 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Induration, Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Induration, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Pruritus, Grade 1
|
7 Participants
|
6 Participants
|
15 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Pruritus, Grade 2
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Injection Site Pruritus, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 8 days after any vaccinationPopulation: Full Analysis Set
Number of Participants with solicited systemic/general AEs (pyrexia, headache, myalgia, nausea, fatigue, and chills) by intensity. Percentages based on subjects with at least one completed diary card. \[Body temperature: 0 = \<99.5 F (\<37.5 C), 1 = ≥99.5 - \<100.4 F (≥37.5 - \<38.0 C), 2= ≥100.4 - \<102.2 F (≥38.0 - \<39.0 C), 3= ≥102.2 - \<104.0 F (≥39.0 - \<40.0 C), 4= ≥ 104.0 F (≥40.0 C); pyrexia is defined as oral temperature ≥ 100.4 F (≥ 38.0 C).\] \[Headache, myalgia, nausea, chills and fatigue: 0 = none, 1 = mild: easily tolerated, minimal discomfort and no interference with daily activity, 2 = moderate: some interference with daily activity, 3 = severe: prevents daily activity.\]
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Number of Participants With Solicited General AEs
Pyrexia, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited General AEs
Pyrexia, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited General AEs
Pyrexia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited General AEs
Headache, Grade 1
|
8 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Solicited General AEs
Headache, Grade 2
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited General AEs
Headache, Grade 3
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited General AEs
Myalgia, Grade 1
|
6 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Solicited General AEs
Myalgia, Grade 2
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Solicited General AEs
Myalgia, Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited General AEs
Chills, Grade 1
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Solicited General AEs
Chills, Grade 2
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited General AEs
Chills, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited General AEs
Nausea, Grade 1
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Solicited General AEs
Nausea, Grade 2
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited General AEs
Nausea, Grade 3
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited General AEs
Fatigue, Grade 1
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Solicited General AEs
Fatigue, Grade 2
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Solicited General AEs
Fatigue, Grade 3
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 15 days after each vaccinationPopulation: Full Analysis Set
Mean CD4+ T-cell counts over time
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=27 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
CD4+ T Cell Counts
Screening
|
304.9 CD4 count (cells/µL)
Standard Deviation 104.77
|
295.3 CD4 count (cells/µL)
Standard Deviation 111.10
|
349.6 CD4 count (cells/µL)
Standard Deviation 133.71
|
|
CD4+ T Cell Counts
Week 2
|
337.4 CD4 count (cells/µL)
Standard Deviation 118.18
|
357.0 CD4 count (cells/µL)
Standard Deviation 157.87
|
335.7 CD4 count (cells/µL)
Standard Deviation 111.11
|
|
CD4+ T Cell Counts
Week 6
|
319.1 CD4 count (cells/µL)
Standard Deviation 117.91
|
365.4 CD4 count (cells/µL)
Standard Deviation 197.04
|
345.0 CD4 count (cells/µL)
Standard Deviation 96.22
|
|
CD4+ T Cell Counts
Week 14
|
NA CD4 count (cells/µL)
Standard Deviation NA
N/A=week 14 visit not scheduled for Group 1
|
NA CD4 count (cells/µL)
Standard Deviation NA
N/A=week 14 visit not scheduled for Group 2
|
351.9 CD4 count (cells/µL)
Standard Deviation 114.53
|
SECONDARY outcome
Timeframe: within 64 weeksPopulation: Per-protocol Set
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=20 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=26 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Week 0
|
1.5 Titer
Interval 0.8 to 2.6
|
1.2 Titer
Interval 0.8 to 1.7
|
1.8 Titer
Interval 0.9 to 3.5
|
|
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Week 4
|
40.0 Titer
Interval 15.3 to 105.1
|
47.1 Titer
Interval 20.7 to 107.1
|
41.8 Titer
Interval 16.2 to 107.8
|
|
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Week 6
|
552.2 Titer
Interval 337.1 to 904.4
|
846.1 Titer
Interval 475.3 to 1506.1
|
726.1 Titer
Interval 371.3 to 1419.8
|
|
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Week 12
|
NA Titer
N/A=week 12 and 14 visits not scheduled for Group 1
|
NA Titer
N/A=week 12 and 14 visits not scheduled for Group 2
|
193.1 Titer
Interval 90.9 to 410.5
|
|
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Week 14
|
NA Titer
N/A=week 12 and 14 visits not scheduled for Group 1
|
NA Titer
N/A=week 12 and 14 visits not scheduled for Group 2
|
1591.2 Titer
Interval 1158.1 to 2186.3
|
|
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Week 30/38
|
34.6 Titer
Interval 12.2 to 98.5
|
30.8 Titer
Interval 11.3 to 83.5
|
143.3 Titer
Interval 67.6 to 303.9
|
|
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Week 56/64
|
25.2 Titer
Interval 8.4 to 75.7
|
27.5 Titer
Interval 9.6 to 79.2
|
116.2 Titer
Interval 57.9 to 233.2
|
SECONDARY outcome
Timeframe: Week 6Population: Per-protocol Set
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=46 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
ELISA GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
|
644.6 Titer
Interval 422.7 to 983.0
|
846.1 Titer
Interval 475.3 to 1506.1
|
—
|
SECONDARY outcome
Timeframe: Week 6 (Groups 1 and 2), Week 14 (Group 3)Population: Per-protocol Set
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=20 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=26 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
ELISA GMT 2 Weeks Following the Last Vaccination
|
552.2 Titer
Interval 337.1 to 904.4
|
846.1 Titer
Interval 475.3 to 1506.1
|
1591.2 Titer
Interval 1158.1 to 2186.3
|
SECONDARY outcome
Timeframe: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)Population: Per-protocol Set
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=18 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=22 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=24 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
ELISA GMT During Follow-up
Week 30/38
|
34.6 Titer
Interval 12.2 to 98.5
|
30.8 Titer
Interval 11.3 to 83.5
|
143.3 Titer
Interval 67.6 to 303.9
|
|
ELISA GMT During Follow-up
Week 56/64
|
25.2 Titer
Interval 8.4 to 75.7
|
27.5 Titer
Interval 9.6 to 79.2
|
116.2 Titer
Interval 57.9 to 233.2
|
SECONDARY outcome
Timeframe: within 64 weeksPopulation: Per-protocol Set
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=20 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=26 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Week 0
|
NA Titer
None of the participants have titer values above the detection limit.
|
NA Titer
None of the participants have titer values above the detection limit.
|
1.2 Titer
Interval 0.8 to 1.9
|
|
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Week 4
|
3.9 Titer
Interval 1.9 to 8.1
|
4.8 Titer
Interval 2.5 to 9.2
|
10.1 Titer
Interval 4.8 to 21.1
|
|
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Week 6
|
78.9 Titer
Interval 49.9 to 124.8
|
100.3 Titer
Interval 59.8 to 168.4
|
95.9 Titer
Interval 54.6 to 168.3
|
|
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Week 12
|
NA Titer
N/A=week 12 and 14 visits not scheduled for Group 1
|
NA Titer
N/A=week 12 and 14 visits not scheduled for Group 2
|
35.5 Titer
Interval 19.6 to 64.5
|
|
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Week 14
|
NA Titer
N/A=week 12 and 14 visits not scheduled for Group 1
|
NA Titer
N/A=week 12 and 14 visits not scheduled for Group 2
|
281.1 Titer
Interval 166.6 to 474.1
|
|
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Week 30/38
|
6.2 Titer
Interval 2.6 to 14.8
|
11.5 Titer
Interval 5.6 to 23.5
|
41.5 Titer
Interval 22.6 to 75.9
|
|
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Week 56/64
|
6.2 Titer
Interval 2.5 to 15.4
|
10.6 Titer
Interval 5.3 to 21.2
|
45.3 Titer
Interval 26.0 to 79.0
|
SECONDARY outcome
Timeframe: Week 6Population: Per-protocol Set
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=46 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
PRNT GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
|
88.1 Titer
Interval 61.3 to 126.6
|
100.3 Titer
Interval 59.8 to 168.4
|
—
|
SECONDARY outcome
Timeframe: Week 6 (Groups 1 and 2), Week 14 (Group 3)Population: Per-protocol Set
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=20 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=26 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
PRNT GMT 2 Weeks Following the Last Vaccination
|
78.9 Titer
Interval 49.9 to 124.8
|
100.3 Titer
Interval 59.8 to 168.4
|
281.1 Titer
Interval 166.6 to 474.1
|
SECONDARY outcome
Timeframe: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)Population: Per-protocol Set
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=18 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=22 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=24 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
PRNT GMT During Follow-up
Week 56/64
|
6.2 Titer
Interval 2.5 to 15.4
|
10.6 Titer
Interval 5.3 to 21.2
|
45.3 Titer
Interval 26.0 to 79.0
|
|
PRNT GMT During Follow-up
Week 30/38
|
6.2 Titer
Interval 2.6 to 14.8
|
11.5 Titer
Interval 5.6 to 23.5
|
41.5 Titer
Interval 22.6 to 75.9
|
SECONDARY outcome
Timeframe: within 64 weeksPopulation: Per-protocol Set
SC rate based on ELISA. SC 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.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=20 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=26 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion by ELISA
Week 4
|
75.0 percentage of subjects
Interval 50.9 to 91.3
|
82.6 percentage of subjects
Interval 61.2 to 95.0
|
69.2 percentage of subjects
Interval 48.2 to 85.7
|
|
Percentage of Participants With Seroconversion by ELISA
Week 6
|
100.0 percentage of subjects
Interval 83.2 to 100.0
|
100.0 percentage of subjects
Interval 85.2 to 100.0
|
92.3 percentage of subjects
Interval 74.9 to 99.1
|
|
Percentage of Participants With Seroconversion by ELISA
Week 12
|
NA percentage of subjects
N/A=week 12 and 14 visits not scheduled for Group 1
|
NA percentage of subjects
N/A=week 12 and 14 visits not scheduled for Group 2
|
84.6 percentage of subjects
Interval 65.1 to 95.6
|
|
Percentage of Participants With Seroconversion by ELISA
Week 14
|
NA percentage of subjects
N/A=week 12 and 14 visits not scheduled for Group 1
|
NA percentage of subjects
N/A=week 12 and 14 visits not scheduled for Group 2
|
100.0 percentage of subjects
Interval 86.8 to 100.0
|
|
Percentage of Participants With Seroconversion by ELISA
Week 30/38
|
77.8 percentage of subjects
Interval 52.4 to 93.6
|
72.7 percentage of subjects
Interval 49.8 to 89.3
|
83.3 percentage of subjects
Interval 62.6 to 95.3
|
|
Percentage of Participants With Seroconversion by ELISA
Week 56/64
|
66.7 percentage of subjects
Interval 41.0 to 86.7
|
68.2 percentage of subjects
Interval 45.1 to 86.1
|
83.3 percentage of subjects
Interval 62.6 to 95.3
|
SECONDARY outcome
Timeframe: Week 6Population: Per-protocol Set
SC rate based on ELISA. SC 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.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=46 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
|
95.7 percentage of subjects
Interval 85.2 to 99.5
|
100.0 percentage of subjects
Interval 85.2 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Week 6 (Groups 1 and 2), Week 14 (Group 3)Population: Per-protocol Set
SC rate based on ELISA. SC 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.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=20 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=26 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Last Vaccination
|
100.0 percentage of subjects
Interval 83.2 to 100.0
|
100.0 percentage of subjects
Interval 85.2 to 100.0
|
100.0 percentage of subjects
Interval 86.8 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)Population: Per-protocol Set
SC rate based on ELISA. SC 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.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=18 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=22 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=24 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion by ELISA During Follow-up
Week 30/38
|
77.8 percentage of subjects
Interval 52.4 to 93.6
|
72.7 percentage of subjects
Interval 49.8 to 89.3
|
83.3 percentage of subjects
Interval 62.6 to 95.3
|
|
Percentage of Participants With Seroconversion by ELISA During Follow-up
Week 56/64
|
66.7 percentage of subjects
Interval 41.0 to 86.7
|
68.2 percentage of subjects
Interval 45.1 to 86.1
|
83.3 percentage of subjects
Interval 62.6 to 95.3
|
SECONDARY outcome
Timeframe: within 64 weeksPopulation: Per-protocol Set
SC rate based on PRNT. SC is defined as the appearance of antibody titers \>= detection limit (2) 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.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=20 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=26 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion by PRNT
Week 4
|
60.0 percentage of subjects
Interval 36.1 to 80.9
|
69.6 percentage of subjects
Interval 47.1 to 86.8
|
80.8 percentage of subjects
Interval 60.6 to 93.4
|
|
Percentage of Participants With Seroconversion by PRNT
Week 6
|
100.0 percentage of subjects
Interval 83.2 to 100.0
|
100.0 percentage of subjects
Interval 85.2 to 100.0
|
96.2 percentage of subjects
Interval 80.4 to 99.9
|
|
Percentage of Participants With Seroconversion by PRNT
Week 12
|
NA percentage of subjects
N/A=week 12 and 14 visits not scheduled for Group 1
|
NA percentage of subjects
N/A=week 12 and 14 visits not scheduled for Group 2
|
96.2 percentage of subjects
Interval 80.4 to 99.9
|
|
Percentage of Participants With Seroconversion by PRNT
Week 14
|
NA percentage of subjects
N/A=week 12 and 14 visits not scheduled for Group 1
|
NA percentage of subjects
N/A=week 12 and 14 visits not scheduled for Group 2
|
100.0 percentage of subjects
Interval 86.8 to 100.0
|
|
Percentage of Participants With Seroconversion by PRNT
Week 30/38
|
72.2 percentage of subjects
Interval 46.5 to 90.3
|
81.8 percentage of subjects
Interval 59.7 to 94.8
|
91.7 percentage of subjects
Interval 73.0 to 99.0
|
|
Percentage of Participants With Seroconversion by PRNT
Week 56/64
|
66.7 percentage of subjects
Interval 41.0 to 86.7
|
72.7 percentage of subjects
Interval 49.8 to 89.3
|
95.8 percentage of subjects
Interval 78.9 to 99.9
|
SECONDARY outcome
Timeframe: Week 6Population: Per-protocol Set
SC rate based on PRNT. SC is defined as the appearance of antibody titers \>= detection limit (2) 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.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=46 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
|
97.8 percentage of subjects
Interval 88.5 to 99.9
|
100.0 percentage of subjects
Interval 85.2 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Week 6 (Groups 1 and 2), Week 14 (Group 3)Population: Per-protocol Set
SC rate based on PRNT. SC is defined as the appearance of antibody titers \>= detection limit (2) 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.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=20 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=23 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=26 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Last Vaccination
|
100.0 percentage of subjects
Interval 83.2 to 100.0
|
100.0 percentage of subjects
Interval 85.2 to 100.0
|
100.0 percentage of subjects
Interval 86.8 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)Population: Per-protocol Set
SC rate based on PRNT. SC is defined as the appearance of antibody titers \>= detection limit (2) 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.
Outcome measures
| Measure |
Group 1 (Standard Regimen)
n=18 Participants
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=22 Participants
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=24 Participants
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion by PRNT During Follow-up
Week 30/38
|
72.2 percentage of subjects
Interval 46.5 to 90.3
|
81.8 percentage of subjects
Interval 59.7 to 94.8
|
91.7 percentage of subjects
Interval 73.0 to 99.0
|
|
Percentage of Participants With Seroconversion by PRNT During Follow-up
Week 56/64
|
66.7 percentage of subjects
Interval 41.0 to 86.7
|
72.7 percentage of subjects
Interval 49.8 to 89.3
|
95.8 percentage of subjects
Interval 78.9 to 99.9
|
Adverse Events
Group 1 (Standard Regimen)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2 (Double Dose Regimen)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 3 (Booster Regimen)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (Standard Regimen)
n=27 participants at risk
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 participants at risk
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 participants at risk
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
Other adverse events
| Measure |
Group 1 (Standard Regimen)
n=27 participants at risk
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 2 (Double Dose Regimen)
n=29 participants at risk
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
Group 3 (Booster Regimen)
n=31 participants at risk
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
|
|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.7%
1/27 • Number of events 1 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Infections and infestations
Furuncle
|
3.7%
1/27 • Number of events 1 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Infections and infestations
Herpes zoster
|
3.7%
1/27 • Number of events 1 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/27 • within 75 weeks
|
3.4%
1/29 • Number of events 1 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/27 • within 75 weeks
|
3.4%
1/29 • Number of events 1 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Number of events 1 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/27 • within 75 weeks
|
3.4%
1/29 • Number of events 1 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Investigations
Troponin I increased
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/27 • within 75 weeks
|
3.4%
1/29 • Number of events 1 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27 • within 75 weeks
|
3.4%
1/29 • Number of events 1 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/27 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.7%
1/27 • Number of events 1 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/27 • within 75 weeks
|
3.4%
1/29 • Number of events 1 • within 75 weeks
|
3.2%
1/31 • Number of events 1 • within 75 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.7%
1/27 • Number of events 1 • within 75 weeks
|
0.00%
0/29 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • within 75 weeks
|
3.4%
1/29 • Number of events 1 • within 75 weeks
|
0.00%
0/31 • within 75 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place