Phase 3
N=200
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Anthrax
Bottom Line
View on ClinicalTrials.gov: NCT01491607 ↗Enrolled (actual)
200
Serious AEs
1.0%
Results posted
Nov 2013
Primary outcome: 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). — 71.2; 68.5; 73.9; 76.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BioThrax (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emergent BioSolutions
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
71.2; 68.5; 73.9; 76.7; 66.0; 73.7 | — |
| SECONDARY Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. |
57.9; 54.4; 61.3; 67.0; 49.5; 61.5 | — |
| SECONDARY Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). |
52.7; 50.0; 55.4; 58.4; 47.7; 56.0 | — |
| SECONDARY Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards |
93; 94; 9; 0; 103; 85 | — |
| SECONDARY Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards |
47.4; 48.0; 4.6; 0; 52.6; 43.4 | — |
| SECONDARY Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards |
138; 48; 10; 0; 58; 135 | — |
| SECONDARY Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards |
70.4; 24.5; 5.1; 0; 29.6; 68.9 | — |
Summary
The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.
This study will be conducted in the United States (U.S.), in 200 healthy male and female volunteer subjects ages 18 to 65 years.
The duration of study participation for each individual subject will be approximately 128 days (4.25 months), including a screening period of approximately 28 days followed by 100 days on study.
Eligibility Criteria
Inclusion Criteria
- Be between 18 and 65 years of age, inclusive, at the time of enrollment.
- Be in good health as determined by the investigator from medical history and a physical examination.
- If a pre-menopausal female, must be using acceptable methods of birth control.
- Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.
- Be willing and able to return for all visits and blood collections for the duration of the study.
- Have read, understood and signed an informed consent form.
Exclusion Criteria
- Prior immunization with anthrax vaccine or known exposure to anthrax organisms.
- Intend to enlist in the military during the study.
- Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.
- Plan to receive experimental products at any time during the study.
- Have received a live vaccine in the 30 days before study entry.
- Plan to receive a live vaccine at any time during the study.
- Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates;
- Have received immunosuppressive therapy (including systemic steroids) within 3 months prior to study entry.
- Have a condition known to produce or be associated with immunosuppression.
- Have received cytotoxic therapy in the previous 5 years.
- A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study.
Data sourced from ClinicalTrials.gov (NCT01491607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.