Trial Outcomes & Findings for Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study (NCT NCT04067011)
NCT ID: NCT04067011
Last Updated: 2025-09-08
Results Overview
Based on serum concentrations of ciprofloxacin on Day 8 (pre-AV7909 vaccination) and on Day 35 (post-AV7909 vaccination), steady state AUC0-12h and Cmax were derived, and geometric mean of ratio of AUC0-12h on Day35/Day 8 and geometric mean of ratio for Cmax on Day 35/Day8, and the corresponding 90% CI of the mean ratios were calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
210 participants
Primary outcome timeframe
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours post-ciprofloxacin dose on Days 8 (pre-AV7909 vaccination) and 35 (post-AV7909 vaccination)
Results posted on
2025-09-08
Participant Flow
Participant milestones
| Measure |
Group 1:Ciprofloxacin + AV7909
Group 1 concomitantly received ciprofloxacin and AV7909.
Ciprofloxacin 500Mg Tablet: Ciprofloxacin 500mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 2: Doxycycline +AV7909
Group 2 concomitantly received doxycycline and AV7909.
Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 3: AV7909
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
69
|
|
Overall Study
COMPLETED
|
51
|
58
|
61
|
|
Overall Study
NOT COMPLETED
|
19
|
13
|
8
|
Reasons for withdrawal
| Measure |
Group 1:Ciprofloxacin + AV7909
Group 1 concomitantly received ciprofloxacin and AV7909.
Ciprofloxacin 500Mg Tablet: Ciprofloxacin 500mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 2: Doxycycline +AV7909
Group 2 concomitantly received doxycycline and AV7909.
Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 3: AV7909
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
|---|---|---|---|
|
Overall Study
Not Treated
|
8
|
7
|
5
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Other Reasons
|
2
|
0
|
1
|
|
Overall Study
Missing
|
0
|
2
|
0
|
Baseline Characteristics
Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
Baseline characteristics by cohort
| Measure |
Group 1:Ciprofloxacin + AV7909
n=70 Participants
Group 1 concomitantly received ciprofloxacin and AV7909.
Ciprofloxacin 500mg Tablet: Ciprofloxacin 500mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 2: Doxycycline +AV7909
n=71 Participants
Group 2 concomitantly received doxycycline and AV7909.
Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 3: AV7909
n=69 Participants
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 - 30 years
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Age, Customized
31 - 45 years
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
71 participants
n=7 Participants
|
69 participants
n=5 Participants
|
210 participants
n=4 Participants
|
|
Height
|
170.1 cm
STANDARD_DEVIATION 9.8 • n=5 Participants
|
169.1 cm
STANDARD_DEVIATION 8.5 • n=7 Participants
|
169.7 cm
STANDARD_DEVIATION 10.7 • n=5 Participants
|
169.6 cm
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Weight
|
78.7 kg
STANDARD_DEVIATION 16.7 • n=5 Participants
|
79.4 kg
STANDARD_DEVIATION 12.6 • n=7 Participants
|
75.0 kg
STANDARD_DEVIATION 16.0 • n=5 Participants
|
77.7 kg
STANDARD_DEVIATION 15.2 • n=4 Participants
|
|
BMI
|
27.1 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 3.7 • n=7 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 4.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours post-ciprofloxacin dose on Days 8 (pre-AV7909 vaccination) and 35 (post-AV7909 vaccination)Population: The number of analyzed participants represents the number of participants that met pre-specified protocol criteria for inclusion in the PK analysis population.
Based on serum concentrations of ciprofloxacin on Day 8 (pre-AV7909 vaccination) and on Day 35 (post-AV7909 vaccination), steady state AUC0-12h and Cmax were derived, and geometric mean of ratio of AUC0-12h on Day35/Day 8 and geometric mean of ratio for Cmax on Day 35/Day8, and the corresponding 90% CI of the mean ratios were calculated.
Outcome measures
| Measure |
Ciprofloxacin + AV7909
n=25 Participants
Participants meeting entry criteria were randomized 1:1:1 to one of three investigational study groups. Groups 1 to 3 each received a manufactured lot of AV7909 per the study visit schedule.
Group 1 concomitantly received ciprofloxacin.
Ciprofloxacin 500Mg Tablet: Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.
|
Group 2: Doxycycline +AV7909
Group 2 concomitantly received doxycycline. Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 3: AV7909
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
|---|---|---|---|
|
Ratio of Ciprofloxacin Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 35
Ratios of AUC0-12h (Post-vac./Pre-vac)
|
0.9764 Ratio
Interval 0.8895 to 1.0718
|
—
|
—
|
|
Ratio of Ciprofloxacin Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 35
Ratios of Cmax (Post-vac./Pre-vac)
|
0.9706 Ratio
Interval 0.8693 to 1.0838
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours post-doxycycline dose on Days 8 (pre-AV7909 vaccination) and 38 (post-AV7909 vaccination)Population: The number of analyzed participants represents the number of participants that met pre-specified protocol criteria for inclusion in the PK analysis population.
Based on serum concentrations of doxycycline on Day 8 (pre-AV7909 vaccination) and on Day 38 (post-AV7909 vaccination), steady state AUC0-12h and Cmax were derived, and geometric mean of ratio of AUC0-12h on Day38/Day 8 and geometric mean of ratio for Cmax on Day 38/Day8, and the corresponding 90% CI of the mean ratios were calculated.
Outcome measures
| Measure |
Ciprofloxacin + AV7909
n=31 Participants
Participants meeting entry criteria were randomized 1:1:1 to one of three investigational study groups. Groups 1 to 3 each received a manufactured lot of AV7909 per the study visit schedule.
Group 1 concomitantly received ciprofloxacin.
Ciprofloxacin 500Mg Tablet: Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.
|
Group 2: Doxycycline +AV7909
Group 2 concomitantly received doxycycline. Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 3: AV7909
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
|---|---|---|---|
|
Ratio of Doxycycline Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 38
Ratios of AUC0-12h (Post-vac./Pre-vac)
|
0.9173 Ratio
Interval 0.8187 to 1.0278
|
—
|
—
|
|
Ratio of Doxycycline Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 38
Ratios of Cmax (Post-vac./Pre-vac)
|
0.8974 Ratio
Interval 0.7841 to 1.0271
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 37 ± 1 dayPopulation: The number of analyzed participants represents the number of participants that met pre-specified protocol criteria for inclusion in the immunogenicity analysis population.
Immunogenicity response as assessed by geometric mean of TNA NF50 values at Day 37 (two weeks after second dose of AV7909 vaccination).
Outcome measures
| Measure |
Ciprofloxacin + AV7909
n=47 Participants
Participants meeting entry criteria were randomized 1:1:1 to one of three investigational study groups. Groups 1 to 3 each received a manufactured lot of AV7909 per the study visit schedule.
Group 1 concomitantly received ciprofloxacin.
Ciprofloxacin 500Mg Tablet: Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.
|
Group 2: Doxycycline +AV7909
n=50 Participants
Group 2 concomitantly received doxycycline. Doxycycline 100mg Tablet: Doxycycline 100mg was administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 3: AV7909
n=54 Participants
AV7909: 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
|---|---|---|---|
|
Geometric Mean TNA 50% Neutralizing Factor (NF50) Values Two Weeks After the Second AV7909 Vaccination (Day 37 ± 1 Day).
|
1.8 TNA NF50 titer
Interval 1.3 to 2.4
|
1.8 TNA NF50 titer
Interval 1.4 to 2.3
|
1.6 TNA NF50 titer
Interval 1.3 to 2.0
|
Adverse Events
Group 1: Ciprofloxacin + AV7909
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 2: Doxycycline +AV7909
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 3: AV7909
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Ciprofloxacin + AV7909
n=62 participants at risk
Group 1 concomitantly received ciprofloxacin and AV7909.
Ciprofloxacin 500 mg Tablet: Ciprofloxacin 500 mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.
AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 2: Doxycycline +AV7909
n=64 participants at risk
Group 2 concomitantly received doxycycline and AV7909.
Doxycycline 100 mg Tablet: Doxycycline 100 mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.
AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 3: AV7909
n=64 participants at risk
AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
1.6%
1/62 • Number of events 1 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
0.00%
0/64 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
0.00%
0/64 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/62 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
0.00%
0/64 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
1.6%
1/64 • Number of events 1 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
Other adverse events
| Measure |
Group 1: Ciprofloxacin + AV7909
n=62 participants at risk
Group 1 concomitantly received ciprofloxacin and AV7909.
Ciprofloxacin 500 mg Tablet: Ciprofloxacin 500 mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 4-9, 22-24 and 31-37.
AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 2: Doxycycline +AV7909
n=64 participants at risk
Group 2 concomitantly received doxycycline and AV7909.
Doxycycline 100 mg Tablet: Doxycycline 100 mg administered by mouth every 12 hours. The antibiotic was administered orally on Study Days 2-9, 22-24 and 32-38.
AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
Group 3: AV7909
n=64 participants at risk
AV7909: 0.5 mL AVA and 0.25mg CPG 7909 per 0.5 mL dose. The vaccine was administered intramuscularly on Study Days 8 and 23.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.2%
2/62 • Number of events 2 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
6.2%
4/64 • Number of events 5 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
1.6%
1/64 • Number of events 1 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62 • Number of events 1 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
6.2%
4/64 • Number of events 5 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
1.6%
1/64 • Number of events 1 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
|
Injury, poisoning and procedural complications
Procedural headache
|
3.2%
2/62 • Number of events 2 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
6.2%
4/64 • Number of events 5 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
3.1%
2/64 • Number of events 3 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
|
General disorders
Injection site pain
|
9.7%
6/62 • Number of events 10 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
7.8%
5/64 • Number of events 11 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
12.5%
8/64 • Number of events 17 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
|
General disorders
Injection site induration
|
3.2%
2/62 • Number of events 3 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
10.9%
7/64 • Number of events 8 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
7.8%
5/64 • Number of events 5 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
|
General disorders
Injection site movement impairment
|
4.8%
3/62 • Number of events 3 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
3.1%
2/64 • Number of events 2 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
6.2%
4/64 • Number of events 5 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
4.8%
3/62 • Number of events 3 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
6.2%
4/64 • Number of events 4 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
10.9%
7/64 • Number of events 9 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
|
Injury, poisoning and procedural complications
Musculoskeletal procedural complication
|
6.5%
4/62 • Number of events 4 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
6.2%
4/64 • Number of events 6 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
6.2%
4/64 • Number of events 5 • Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day)
Safety in all groups were assessed up to Day 51 (last in-clinic visit) by collecting adverse events (AEs; including serious adverse event), local and systemic reactogenicity events and assessments of physical examinations, vital signs, clinical laboratories (hematology, serum chemistry, urinalysis). Only participants that received at least one dose of study treatment are included in the safety population (i.e., 62 participants in Group 1; 64 participants in Group 2; 64 participants in Group 3).
|
Additional Information
Clinical Development Representative
Emergent Biosolutions
Phone: +1 (204) 275-4196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place