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

NCT ID: NCT01491607

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-05-31

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.

Conditions

Anthrax

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BioThrax (0.5 mL, on days 0, 14, and 28)

Group Type: EXPERIMENTAL

BioThrax

Intervention Type: BIOLOGICAL

BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.

Interventions

BioThrax

BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.

Intervention Type: BIOLOGICAL

Other Intervention Names

Anthrax Vaccine Adsorbed (AVA)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Hopkins, MD, MPH, TM

Role: PRINCIPAL_INVESTIGATOR

Emergent BioSolutions Inc.

Locations

Miami Research Associates

Miami, Florida, United States

Rochester Clinical Research

Rochester, New York, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

HHSO100200700037C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EBS.AVA.006

Identifier Type: -

Identifier Source: org_study_id