Clinical trial NCT01491607: Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Official title: Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anthrax
Keywords: post-exposure prophylaxis
toxin neutralization assay
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2011-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) is the only FDA-licensed vaccine for the prevention of anthrax infection. This study will evaluate the immunogenicity of the vaccine using a post-exposure vaccination schedule. Correlations will be drawn to immunogenicity and survival data from animal models to demonstrate that BioThrax® can elicit a protective immune response for PEP.

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.

Primary outcomes:
measure: Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).
timeFrame: Day 63 +/- 2 days
Secondary outcomes:
measure: Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.
timeFrame: Day 70 +/- 2 days
measure: Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).
timeFrame: Days 63 to 100
measure: Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
timeFrame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
measure: Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
timeFrame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
measure: Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
timeFrame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
measure: Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
timeFrame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Emergent BioSolutions Inc.
name: Robert Hopkins, MD, MPH, TM
role: PRINCIPAL_INVESTIGATOR
References: