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BARDA Securing Anthrax Immunity For the Elderly (B-SAFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518125
Recruitment Status : Completed
First Posted : May 8, 2018
Results First Posted : June 9, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Rho, Inc.
Information provided by (Responsible Party):
Biomedical Advanced Research and Development Authority

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Anthrax
Interventions Biological: BioThrax
Biological: AV7909
Drug: Sodium chloride injection USP, 0.9% (placebo)
Enrollment 305
Recruitment Details 469 participants were screened at 4 sites in the US between May 14, 2018 - November 8, 2018, of which 305 were randomized and vaccinated between May 17, 2018 - November 12, 2018.
Pre-assignment Details  
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, and Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Days 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909 Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Period Title: Overall Study
Started 50 50 49 52 52 52
Completed 48 46 49 51 48 44
Not Completed 2 4 0 1 4 8
Reason Not Completed
Lost to Follow-up             0             2             0             0             3             5
Physician Decision             0             1             0             0             0             0
Withdrawal by Subject             1             1             0             1             1             3
Missed Day 394 Visit             1             0             0             0             0             0
Arm/Group Title Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Total
Hide Arm/Group Description Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909 Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo Total of all reporting groups
Overall Number of Baseline Participants 50 50 49 52 52 52 305
Hide Baseline Analysis Population Description
Safety population includes all randomized participants who received any amount of study vaccination.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 49 participants 52 participants 52 participants 52 participants 305 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.9%
1
   1.9%
2
   0.7%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
51
  98.1%
51
  98.1%
102
  33.4%
>=65 years
50
 100.0%
50
 100.0%
49
 100.0%
52
 100.0%
0
   0.0%
0
   0.0%
201
  65.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 49 participants 52 participants 52 participants 52 participants 305 participants
72.7  (5.89) 71.2  (4.76) 72.8  (4.88) 72.5  (5.04) 33.5  (9.46) 33.7  (9.55) 59.1  (19.63)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Gender Number Analyzed 50 participants 50 participants 49 participants 52 participants 52 participants 52 participants 305 participants
Female
28
  56.0%
29
  58.0%
27
  55.1%
31
  59.6%
29
  55.8%
29
  55.8%
173
  56.7%
Male
22
  44.0%
21
  42.0%
22
  44.9%
21
  40.4%
23
  44.2%
23
  44.2%
132
  43.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 49 participants 52 participants 52 participants 52 participants 305 participants
Hispanic or Latino
1
   2.0%
2
   4.0%
0
   0.0%
1
   1.9%
0
   0.0%
3
   5.8%
7
   2.3%
Not Hispanic or Latino
49
  98.0%
48
  96.0%
48
  98.0%
50
  96.2%
51
  98.1%
48
  92.3%
294
  96.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   2.0%
1
   1.9%
1
   1.9%
1
   1.9%
4
   1.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 49 participants 52 participants 52 participants 52 participants 305 participants
American Indian or Alaska Native
0
   0.0%
1
   2.0%
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
2
   0.7%
Asian
0
   0.0%
1
   2.0%
0
   0.0%
2
   3.8%
0
   0.0%
1
   1.9%
4
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   8.0%
2
   4.0%
3
   6.1%
2
   3.8%
6
  11.5%
3
   5.8%
20
   6.6%
White
46
  92.0%
46
  92.0%
46
  93.9%
47
  90.4%
45
  86.5%
47
  90.4%
277
  90.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.9%
1
   1.9%
2
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 49 participants 52 participants 52 participants 52 participants 305 participants
50 50 49 52 52 52 305
1.Primary Outcome
Title Solicited Local Reactogenicity Symptoms
Hide Description Count of participants who experienced at least one of the following during the time frame specified on the arm which received the vaccination: injection site warmth, tenderness, itching, pain, restriction of range of arm motion, erythema/redness, palpable or observable lump, induration/swelling, or bruising.
Time Frame Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all randomized participants who received any amount of study vaccination.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 50 50 49 52 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
46
  92.0%
43
  86.0%
40
  81.6%
45
  86.5%
50
  96.2%
50
  96.2%
2.Primary Outcome
Title Solicited Systemic Reactogenicity Symptoms
Hide Description Count of participants who experienced at least one of the following during the time frame specified on the arm which received the vaccination: fatigue, myalgia/muscle ache, headache, and fever.
Time Frame Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all randomized participants who received any amount of study vaccination.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 50 50 49 52 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
14
  28.0%
23
  46.0%
18
  36.7%
20
  38.5%
15
  28.8%
35
  67.3%
3.Primary Outcome
Title Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56
Hide Description The percentage of participants achieving seroprotection based on TNA NF50. A 70% probability of survival was associated with a TNA NF50 level of 0.56 in rabbits exposed to Bacillus anthracis, the bacteria that causes anthrax.
Time Frame Day 64
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 41 39 41 41 42 38
Measure Type: Count of Participants
Unit of Measure: Participants
7
  17.1%
37
  94.9%
19
  46.3%
40
  97.6%
22
  52.4%
23
  60.5%
4.Secondary Outcome
Title Treatment-emergent Unsolicited Adverse Events (AEs)
Hide Description The count of participants who experienced at least one post-vaccination unsolicited AE (i.e. AEs not included in the solicited local and systemic adverse event list through Day 50 and those reported as a serious AE, medically attended adverse event (MAAE), or potentially immune-mediated medical condition (PIMMC) after Day 50).
Time Frame Day 1 through Day 394
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all randomized participants who received any amount of study vaccination.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 50 50 49 52 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
41
  82.0%
34
  68.0%
32
  65.3%
39
  75.0%
30
  57.7%
26
  50.0%
5.Secondary Outcome
Title Treatment-emergent Serious Adverse Events (SAEs)
Hide Description The count of participants who experienced at least one post-vaccination SAE
Time Frame Day 1 through Day 394
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all randomized participants who received any amount of study vaccination.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 50 50 49 52 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
3
   6.0%
3
   6.1%
2
   3.8%
0
   0.0%
2
   3.8%
6.Secondary Outcome
Title Treatment-emergent Medically Attended Adverse Events (MAAEs)
Hide Description Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
Time Frame Day 1 through Day 394
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all randomized participants who received any amount of study vaccination.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 50 50 49 52 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
27
  54.0%
23
  46.0%
21
  42.9%
23
  44.2%
13
  25.0%
14
  26.9%
7.Secondary Outcome
Title Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs)
Hide Description Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
Time Frame Day 1 through Day 394
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all randomized participants who received any amount of study vaccination.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 50 50 49 52 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Solicited Local Reactogenicity Symptoms on the Contralateral Arm
Hide Description Count of participants who experienced at least one of the following during the time frame specified on the arm which did not receive the vaccination: injection site warmth, tenderness, itching, pain, restriction of range of arm motion, erythema/redness, palpable or observable lump, induration/swelling, or bruising.
Time Frame Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all randomized participants who received any amount of study vaccination.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 50 50 49 52 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
11
  22.0%
6
  12.0%
3
   6.1%
5
   9.6%
7
  13.5%
2
   3.8%
9.Secondary Outcome
Title TNA NF50 Antibody Levels
Hide Description A higher TNA NF50 antibody level means a better immune response to the vaccine.
Time Frame Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 41 39 41 41 42 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 1
.03
(.03 to .03)
.03
(.03 to .03)
.03
(.03 to .03)
.03
(.03 to .03)
.03
(.03 to .03)
.03
(.03 to .03)
Day 8
.03
(.03 to .03)
.03
(.03 to .03)
.03
(.03 to .03)
.03
(.03 to .03)
.03
(.03 to .04)
.03
(.03 to .03)
Day 22
.04
(.03 to .05)
.25
(.14 to .45)
.23
(.14 to .39)
.10
(.07 to .14)
.08
(.05 to .11)
.67
(.48 to .95)
Day 29
.11
(.07 to .16)
.77
(.49 to 1.20)
.80
(.54 to 1.17)
.12
(.08 to .16)
.43
(.30 to .63)
1.02
(.80 to 1.31)
Day 36
.36
(.25 to .52)
2.92
(1.90 to 4.48)
.75
(.50 to 1.11)
2.98
(2.08 to 4.27)
.84
(.60 to 1.16)
1.06
(.82 to 1.38)
Day 43
.55
(.45 to .68)
4.26
(3.20 to 5.66)
.69
(.47 to 1.02)
6.73
(5.19 to 8.72)
.94
(.73 to 1.21)
.94
(.72 to 1.21)
Day 50
.45
(.36 to .56)
3.38
(2.58 to 4.43)
.60
(.41 to .88)
5.30
(4.12 to 6.81)
.79
(.61 to 1.03)
.84
(.64 to 1.10)
Day 64
.32
(.25 to .41)
2.36
(1.83 to 3.06)
.44
(.29 to .64)
3.42
(2.63 to 4.43)
.59
(.45 to .78)
.69
(.53 to .89)
Day 85
.20
(.15 to .26)
1.48
(1.17 to 1.87)
.30
(.20 to .45)
2.08
(1.59 to 2.71)
.42
(.30 to .59)
.53
(.40 to .70)
Day 181
.05
(.04 to .07)
.37
(.28 to .48)
.12
(.09 to .17)
.34
(.24 to .46)
.12
(.08 to .16)
.23
(.17 to .32)
Day 394
.04
(.03 to .04)
.14
(.10 to .20)
.10
(.07 to .13)
.09
(.07 to .12)
.05
(.04 to .07)
.16
(.11 to .23)
10.Secondary Outcome
Title TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Hide Description A higher TNA ED50 antibody level means a better immune response to the vaccine.
Time Frame Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 41 39 41 41 42 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 1
16.5
(16.5 to 16.5)
16.5
(16.5 to 16.5)
16.5
(16.5 to 16.5)
16.5
(16.5 to 16.5)
16.5
(16.5 to 16.5)
16.5
(16.5 to 16.5)
Day 8
16.5
(16.5 to 16.5)
16.5
(16.5 to 16.5)
16.5
(16.5 to 16.5)
16.5
(16.5 to 16.5)
17.18
(15.83 to 18.66)
16.5
(16.5 to 16.5)
Day 22
20.13
(16.84 to 24.06)
136.20
(77.04 to 240.78)
122.26
(73.04 to 204.66)
52.24
(35.89 to 76.03)
35.66
(24.05 to 52.87)
322.78
(228.43 to 456.10)
Day 29
54.88
(36.12 to 83.36)
410.47
(263.48 to 639.47)
411.94
(280.68 to 604.59)
63.02
(44.68 to 88.88)
208.90
(144.37 to 302.28)
501.88
(391.96 to 642.64)
Day 36
187.97
(130.74 to 270.25)
1557.95
(1030.38 to 2355.64)
389.79
(262.37 to 579.07)
1548.57
(1102.91 to 2174.32)
410.11
(297.17 to 565.97)
519.81
(397.84 to 679.18)
Day 43
299.59
(243.47 to 368.64)
2135.14
(1605.51 to 2839.48)
361.30
(245.67 to 531.35)
3490.12
(2737.94 to 4448.95)
495.07
(386.91 to 633.48)
497.77
(384.03 to 645.20)
Day 50
250.88
(201.26 to 312.73)
1658.94
(1265.22 to 2175.19)
315.10
(214.65 to 462.54)
2600.22
(2035.57 to 3321.51)
414.59
(317.69 to 541.06)
435.56
(331.22 to 572.77)
Day 64
184.31
(145.92 to 232.80)
1240.66
(976.70 to 1575.97)
248.04
(168.46 to 365.21)
1771.46
(1386.67 to 2263.02)
321.15
(241.54 to 427.00)
363.05
(279.48 to 471.62)
Day 85
85.20
(63.60 to 114.11)
650.14
(511.93 to 825.65)
136.72
(93.76 to 199.38)
902.39
(689.72 to 1180.63)
181.14
(130.24 to 251.92)
224.09
(171.05 to 293.57)
Day 181
25.55
(20.08 to 32.51)
163.46
(124.59 to 214.46)
55.87
(40.37 to 77.31)
151.24
(111.24 to 205.61)
55.17
(39.33 to 77.39)
108.67
(80.46 to 146.78)
Day 394
18.29
(16.52 to 20.24)
74.48
(52.50 to 105.68)
49.63
(35.44 to 69.49)
50.29
(37.22 to 67.97)
27.46
(20.16 to 37.39)
76.66
(52.84 to 111.21)
11.Secondary Outcome
Title Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Hide Description A higher ELISA anti-PA IgG antibody level means a better immune response to the vaccine.
Time Frame Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 41 39 41 41 42 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 1
4.64
(4.64 to 4.64)
4.78
(4.49 to 5.09)
4.64
(4.64 to 4.64)
4.91
(4.51 to 5.34)
4.64
(4.64 to 4.64)
4.64
(4.64 to 4.64)
Day 8
4.64
(4.64 to 4.64)
4.77
(4.50 to 5.07)
4.64
(4.64 to 4.64)
4.96
(4.49 to 5.48)
4.78
(4.49 to 5.09)
4.64
(4.64 to 4.64)
Day 22
6.06
(4.78 to 7.68)
37.28
(22.32 to 62.27)
40.33
(25.68 to 63.36)
10.26
(7.19 to 14.62)
19.61
(12.91 to 29.77)
80.66
(58.31 to 111.57)
Day 29
29.84
(19.12 to 46.58)
124.04
(84.60 to 181.85)
138.17
(97.23 to 196.34)
11.98
(8.29 to 17.31)
106.64
(75.80 to 150.02)
139.82
(112.50 to 173.79)
Day 36
75.98
(52.39 to 110.20)
347.86
(243.34 to 497.29)
134.15
(94.10 to 191.25)
232.20
(165.79 to 325.21)
180.58
(131.55 to 247.90)
135.86
(109.84 to 168.05)
Day 43
118.55
(91.81 to 153.09)
493.50
(382.46 to 636.78)
122.18
(87.02 to 171.55)
504.56
(394.48 to 645.35)
211.41
(164.67 to 271.43)
120.44
(96.47 to 150.36)
Day 50
100.39
(77.25 to 130.45)
417.04
(323.71 to 537.28)
104.99
(74.97 to 147.03)
418.50
(330.55 to 529.85)
170.18
(131.18 to 220.79)
107.84
(86.93 to 133.77)
Day 64
69.71
(53.58 to 90.70)
334.57
(259.73 to 430.97)
80.74
(58.90 to 110.69)
312.36
(246.20 to 396.30)
124.79
(95.68 to 162.77)
81.47
(65.02 to 102.08)
Day 85
43.50
(33.31 to 56.82)
208.58
(162.53 to 267.69)
48.40
(35.84 to 65.36)
195.23
(154.55 to 246.62)
67.78
(51.26 to 89.63)
50.33
(40.58 to 62.43)
Day 181
9.43
(7.16 to 12.42)
42.60
(32.44 to 55.92)
11.70
(8.86 to 15.44)
36.95
(28.22 to 48.37)
17.43
(12.76 to 23.81)
17.90
(13.83 to 23.16)
Day 394
4.76
(4.51 to 5.02)
12.52
(9.09 to 17.23)
7.09
(5.74 to 8.76)
9.24
(7.30 to 11.70)
6.74
(5.14 to 8.83)
10.33
(8.17 to 13.06)
12.Secondary Outcome
Title Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Hide Description The percentage of participants achieving seroprotection based on TNA NF50 antibody level. A 70% probability of survival was associated with a TNA NF50 level of 0.56 in rabbits exposed to Bacillus anthracis, the bacteria that causes anthrax.
Time Frame Days 1, 8, 22, 29, 36, 43, 50, 85, 181, and 394
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 41 39 41 41 42 38
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 8
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 22
0
   0.0%
18
  46.2%
14
  34.1%
4
   9.8%
2
   4.8%
24
  63.2%
Day 29
6
  14.6%
27
  69.2%
25
  61.0%
4
   9.8%
18
  42.9%
31
  81.6%
Day 36
15
  36.6%
35
  89.7%
28
  68.3%
38
  92.7%
33
  78.6%
31
  81.6%
Day 43
19
  46.3%
37
  94.9%
24
  58.5%
40
  97.6%
33
  78.6%
31
  81.6%
Day 50
14
  34.1%
38
  97.4%
25
  61.0%
40
  97.6%
30
  71.4%
30
  78.9%
Day 85
5
  12.2%
34
  87.2%
15
  36.6%
38
  92.7%
13
  31.0%
19
  50.0%
Day 181
0
   0.0%
11
  28.2%
4
   9.8%
13
  31.7%
2
   4.8%
5
  13.2%
Day 394
0
   0.0%
3
   7.7%
2
   4.9%
1
   2.4%
1
   2.4%
2
   5.3%
13.Secondary Outcome
Title Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Hide Description The percentage of subjects obtaining seroconversion based on TNA NF50 antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time Frame Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 41 39 41 41 42 38
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 22
1
   2.4%
22
  56.4%
19
  46.3%
10
  24.4%
7
  16.7%
31
  81.6%
Day 29
9
  22.0%
30
  76.9%
34
  82.9%
9
  22.0%
30
  71.4%
37
  97.4%
Day 36
28
  68.3%
37
  94.9%
33
  80.5%
39
  95.1%
37
  88.1%
37
  97.4%
Day 43
38
  92.7%
38
  97.4%
32
  78.0%
41
 100.0%
40
  95.2%
37
  97.4%
Day 50
34
  82.9%
39
 100.0%
30
  73.2%
41
 100.0%
37
  88.1%
36
  94.7%
Day 64
27
  65.9%
39
 100.0%
27
  65.9%
41
 100.0%
35
  83.3%
35
  92.1%
Day 85
17
  41.5%
39
 100.0%
23
  56.1%
41
 100.0%
32
  76.2%
35
  92.1%
Day 181
4
   9.8%
26
  66.7%
12
  29.3%
27
  65.9%
8
  19.0%
19
  50.0%
Day 394
0
   0.0%
13
  33.3%
7
  17.1%
7
  17.1%
3
   7.1%
17
  44.7%
14.Secondary Outcome
Title Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Hide Description The percentage of subjects obtaining seroconversion based on TNA ED50 antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time Frame Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 41 39 41 41 42 38
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 22
1
   2.4%
22
  56.4%
20
  48.8%
11
  26.8%
6
  14.3%
32
  84.2%
Day 29
8
  19.5%
30
  76.9%
34
  82.9%
10
  24.4%
29
  69.0%
36
  94.7%
Day 36
29
  70.7%
37
  94.9%
34
  82.9%
40
  97.6%
38
  90.5%
37
  97.4%
Day 43
37
  90.2%
38
  97.4%
32
  78.0%
41
 100.0%
41
  97.6%
37
  97.4%
Day 50
34
  82.9%
39
 100.0%
31
  75.6%
41
 100.0%
37
  88.1%
36
  94.7%
Day 64
29
  70.7%
39
 100.0%
32
  78.0%
41
 100.0%
36
  85.7%
36
  94.7%
Day 85
15
  36.6%
38
  97.4%
22
  53.7%
40
  97.6%
31
  73.8%
32
  84.2%
Day 181
3
   7.3%
24
  61.5%
8
  19.5%
25
  61.0%
7
  16.7%
18
  47.4%
Day 394
0
   0.0%
12
  30.8%
8
  19.5%
7
  17.1%
3
   7.1%
13
  34.2%
15.Secondary Outcome
Title Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Hide Description The percentage of subjects obtaining seroconversion based on ELISA anti-PA IgG antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time Frame Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
Arm/Group Title Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description:
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
Overall Number of Participants Analyzed 41 39 41 41 42 38
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 22
2
   4.9%
22
  56.4%
20
  48.8%
8
  19.5%
12
  28.6%
33
  86.8%
Day 29
16
  39.0%
31
  79.5%
38
  92.7%
9
  22.0%
36
  85.7%
37
  97.4%
Day 36
33
  80.5%
37
  94.9%
37
  90.2%
38
  92.7%
39
  92.9%
37
  97.4%
Day 43
39
  95.1%
38
  97.4%
36
  87.8%
41
 100.0%
41
  97.6%
36
  94.7%
Day 50
38
  92.7%
39
 100.0%
36
  87.8%
41
 100.0%
40
  95.2%
36
  94.7%
Day 64
31
  75.6%
39
 100.0%
34
  82.9%
41
 100.0%
38
  90.5%
36
  94.7%
Day 85
23
  56.1%
39
 100.0%
25
  61.0%
41
 100.0%
32
  76.2%
28
  73.7%
Day 181
4
   9.8%
23
  59.0%
4
   9.8%
24
  58.5%
10
  23.8%
7
  18.4%
Day 394
0
   0.0%
4
  10.3%
0
   0.0%
3
   7.3%
1
   2.4%
0
   0.0%
Time Frame From the first dose of study vaccine through Day 394.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Hide Arm/Group Description Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909 Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5mL placebo Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
All-Cause Mortality
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/50 (0.00%)      0/49 (0.00%)      0/52 (0.00%)      0/52 (0.00%)      0/52 (0.00%)    
Hide Serious Adverse Events
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/50 (2.00%)      3/50 (6.00%)      3/49 (6.12%)      2/52 (3.85%)      0/52 (0.00%)      2/52 (3.85%)    
Blood and lymphatic system disorders             
Anaemia  1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Cardiac disorders             
Acute myocardial infarction  1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis  1  0/50 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0
Infections and infestations             
Urinary tract infection  1  0/50 (0.00%)  0 1/50 (2.00%)  1 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Injury, poisoning and procedural complications             
Femur fracture  1  0/50 (0.00%)  0 1/50 (2.00%)  1 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Lumbar vertebral fracture  1  1/50 (2.00%)  1 0/50 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Metabolism and nutrition disorders             
Dehydration  1  0/50 (0.00%)  0 1/50 (2.00%)  1 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Non-small cell lung cancer metastatic  1  0/50 (0.00%)  0 1/50 (2.00%)  1 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Prostate cancer  1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Abortion spontaneous  1  0/50 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 2/52 (3.85%)  2
Renal and urinary disorders             
Renal failure  1  0/50 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders             
Pneumonia aspiration  1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Vascular disorders             
Deep vein thrombosis  1  0/50 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Hypertension  1  0/50 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0
1
Term from vocabulary, 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/50 (98.00%)      46/50 (92.00%)      44/49 (89.80%)      50/52 (96.15%)      50/52 (96.15%)      51/52 (98.08%)    
Gastrointestinal disorders             
Nausea  1  1/50 (2.00%)  1 3/50 (6.00%)  3 1/49 (2.04%)  1 1/52 (1.92%)  1 1/52 (1.92%)  1 4/52 (7.69%)  4
General disorders             
Chills  1  0/50 (0.00%)  0 2/50 (4.00%)  4 2/49 (4.08%)  2 3/52 (5.77%)  3 0/52 (0.00%)  0 2/52 (3.85%)  2
Fatigue  1  9/50 (18.00%)  12 17/50 (34.00%)  25 14/49 (28.57%)  17 14/52 (26.92%)  21 10/52 (19.23%)  14 21/52 (40.38%)  28
Injection site bruising  1  12/50 (24.00%)  14 4/50 (8.00%)  4 7/49 (14.29%)  8 3/52 (5.77%)  4 9/52 (17.31%)  10 7/52 (13.46%)  7
Injection site discolouration  1  4/50 (8.00%)  5 0/50 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Injection site erythema  1  34/50 (68.00%)  74 13/50 (26.00%)  18 7/49 (14.29%)  8 7/52 (13.46%)  8 27/52 (51.92%)  55 5/52 (9.62%)  5
Injection site induration  1  34/50 (68.00%)  74 15/50 (30.00%)  22 7/49 (14.29%)  7 11/52 (21.15%)  14 29/52 (55.77%)  57 12/52 (23.08%)  14
Injection site mass  1  38/50 (76.00%)  93 10/50 (20.00%)  12 5/49 (10.20%)  5 12/52 (23.08%)  16 37/52 (71.15%)  75 8/52 (15.38%)  9
Injection site movement impairment  1  7/50 (14.00%)  10 22/50 (44.00%)  31 10/49 (20.41%)  17 10/52 (19.23%)  13 15/52 (28.85%)  30 24/52 (46.15%)  32
Injection site pain  1  44/50 (88.00%)  152 41/50 (82.00%)  126 36/49 (73.47%)  77 43/52 (82.69%)  91 49/52 (94.23%)  191 50/52 (96.15%)  138
Injection site pruritus  1  26/50 (52.00%)  48 7/50 (14.00%)  9 3/49 (6.12%)  3 4/52 (7.69%)  6 30/52 (57.69%)  60 5/52 (9.62%)  7
Injection site warmth  1  26/50 (52.00%)  65 21/50 (42.00%)  31 11/49 (22.45%)  13 15/52 (28.85%)  25 27/52 (51.92%)  60 13/52 (25.00%)  19
Pyrexia  1  0/50 (0.00%)  0 3/50 (6.00%)  4 5/49 (10.20%)  5 5/52 (9.62%)  6 3/52 (5.77%)  3 7/52 (13.46%)  8
Infections and infestations             
Bronchitis  1  3/50 (6.00%)  3 1/50 (2.00%)  1 1/49 (2.04%)  1 2/52 (3.85%)  2 0/52 (0.00%)  0 1/52 (1.92%)  1
Upper respiratory tract infection  1  3/50 (6.00%)  3 2/50 (4.00%)  3 7/49 (14.29%)  8 5/52 (9.62%)  5 1/52 (1.92%)  2 3/52 (5.77%)  3
Urinary tract infection  1  1/50 (2.00%)  1 3/50 (6.00%)  3 0/49 (0.00%)  0 1/52 (1.92%)  1 1/52 (1.92%)  2 0/52 (0.00%)  0
Injury, poisoning and procedural complications             
Muscle strain  1  3/50 (6.00%)  3 0/50 (0.00%)  0 1/49 (2.04%)  1 3/52 (5.77%)  4 0/52 (0.00%)  0 1/52 (1.92%)  1
Metabolism and nutrition disorders             
Decreased appetite  1  0/50 (0.00%)  0 3/50 (6.00%)  3 2/49 (4.08%)  2 0/52 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Hypercholesterolaemia  1  0/50 (0.00%)  0 3/50 (6.00%)  3 0/49 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  4/50 (8.00%)  4 3/50 (6.00%)  3 3/49 (6.12%)  3 3/52 (5.77%)  3 0/52 (0.00%)  0 1/52 (1.92%)  1
Musculoskeletal pain  1  2/50 (4.00%)  3 3/50 (6.00%)  3 2/49 (4.08%)  2 1/52 (1.92%)  1 1/52 (1.92%)  1 0/52 (0.00%)  0
Myalgia  1  2/50 (4.00%)  4 11/50 (22.00%)  19 8/49 (16.33%)  9 13/52 (25.00%)  20 8/52 (15.38%)  12 26/52 (50.00%)  37
Neck pain  1  1/50 (2.00%)  1 3/50 (6.00%)  4 1/49 (2.04%)  1 1/52 (1.92%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0
Osteoarthritis  1  2/50 (4.00%)  3 4/50 (8.00%)  4 0/49 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0
Pain in extremity  1  4/50 (8.00%)  4 3/50 (6.00%)  3 0/49 (0.00%)  0 2/52 (3.85%)  2 0/52 (0.00%)  0 2/52 (3.85%)  2
Nervous system disorders             
Headache  1  11/50 (22.00%)  17 18/50 (36.00%)  41 6/49 (12.24%)  16 17/52 (32.69%)  26 12/52 (23.08%)  17 26/52 (50.00%)  37
Vascular disorders             
Hypertension  1  0/50 (0.00%)  0 1/50 (2.00%)  1 4/49 (8.16%)  4 2/52 (3.85%)  2 1/52 (1.92%)  1 1/52 (1.92%)  1
1
Term from vocabulary, 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Data and results are owned by Sponsor. Results can be used by Institution for (a) internal non-commercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Hollingsworth/Regulatory Operations Specialist
Organization: BARDA
Phone: 202-691-2040
EMail: Susan.Hollingsworth@hhs.gov
Layout table for additonal information
Responsible Party: Biomedical Advanced Research and Development Authority
ClinicalTrials.gov Identifier: NCT03518125    
Other Study ID Numbers: BP-C-17001
HHSO100201400004I ( Other Grant/Funding Number: BARDA )
First Submitted: April 24, 2018
First Posted: May 8, 2018
Results First Submitted: May 18, 2020
Results First Posted: June 9, 2020
Last Update Posted: July 21, 2020