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

NCT01491607 | Completed Phase 3 Results

• 2 other identifiers: EBS.AVA.006HHSO100200700037C
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Anthrax

Keywords

post-exposure prophylaxis; toxin neutralization assay

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).

  Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.

  Day 63 +/- 2 days

Secondary Outcomes (6)

• Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.

  Day 70 +/- 2 days

• Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).

  Days 63 to 100

• Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards

  Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

• Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards

  Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

• Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards

  Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

Study Arms (1)

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

EXPERIMENTAL

Biological: BioThrax

Interventions

BioThrax BIOLOGICAL

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

Also known as: Anthrax Vaccine Adsorbed (AVA)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Department of Health and Human Services: collaborator

Study Sites (4)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Biothrax; Anthrax Vaccines

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Robert Hopkins
• Organization: Emergent BioSolutions

hopkinsr@ebsi.com

(301) 944-0136

Study Officials

• Robert Hopkins, MD, MPH, TM

  Emergent BioSolutions Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 9, 2024
• Results First Posted: November 28, 2013

Record last verified: 2024-03

Locations

US (4)