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Completed

NCT Number: NCT01491607

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Miami Research Associates, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BioThrax

Biological

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

Other names: Anthrax Vaccine Adsorbed (AVA)

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).

    Time frame: Day 63 +/- 2 days

    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.

Secondary outcomes

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

    Time frame: Day 70 +/- 2 days

    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.

  2. 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

    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.

  3. 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).

    Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.

  4. 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).

    Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.

  5. 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).

    Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.

  6. 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).

    Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Collaborators

  • Department of Health and Human Services

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2011
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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