Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT01491607
First received: December 12, 2011
Last updated: September 25, 2013
Last verified: September 2013
Results First Received: July 11, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anthrax
Intervention: Biological: BioThrax

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 9 November 2011 to 9 May 2012 at four medical centers in the U.S.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants met the inclusion and exclusion criteria.

Reporting Groups
  Description
BioThrax Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).

Participant Flow:   Overall Study
    BioThrax  
STARTED     200  
COMPLETED     190  
NOT COMPLETED     10  
Lost to Follow-up                 7  
Withdrawal by Subject                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants 18 to 65 years of age who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.

Reporting Groups
  Description
BioThrax - Site 01 Subjects from Site 01 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
BioThrax - Site 02 Subjects from Site 02 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
BioThrax - Site 03 Subjects from Site 03 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
BioThrax - Site 04 Subjects from Site 04 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
Total Total of all reporting groups

Baseline Measures
    BioThrax - Site 01     BioThrax - Site 02     BioThrax - Site 03     BioThrax - Site 04     Total  
Number of Participants  
[units: participants]
  45     34     56     49     184  
Age  
[units: participants]
         
<=18 years     1     1     0     1     3  
Between 18 and 65 years     44     33     56     48     181  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.0  ± 11.41     36.7  ± 10.97     32.7  ± 9.89     34.2  ± 11.09     33.7  ± 10.84  
Gender  
[units: participants]
         
Female     22     19     29     22     92  
Male     23     15     27     27     92  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     2     15     1     2     20  
Not Hispanic or Latino     43     19     55     47     164  
Unknown or Not Reported     0     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
         
White     42     20     49     45     156  
Black or African American     0     14     3     3     20  
Asian     2     0     2     1     5  
American Indian or Alaska Native     1     0     1     0     2  
Native Hawaiian or Other Pacific Islander     0     0     1     0     1  
Region of Enrollment  
[units: participants]
         
United States     45     34     56     49     184  



  Outcome Measures
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1.  Primary:   Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).   [ Time Frame: Day 63 +/- 2 days ]

2.  Secondary:   Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.   [ Time Frame: Day 70 +/- 2 days ]

3.  Secondary:   Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).   [ Time Frame: Days 63 to 100 ]

4.  Secondary:   Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards   [ Time Frame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28). ]

5.  Secondary:   Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards   [ Time Frame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28). ]

6.  Secondary:   Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards   [ Time Frame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28). ]

7.  Secondary:   Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards   [ Time Frame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28). ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Robert Hopkins
Organization: Emergent BioSolutions
phone: (301) 944-0136
e-mail: hopkinsr@ebsi.com


No publications provided


Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT01491607     History of Changes
Other Study ID Numbers: EBS.AVA.006, HHSO100200700037C
Study First Received: December 12, 2011
Results First Received: July 11, 2013
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration