Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.

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Detailed Description

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AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine, adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant, and one which increases the speed and the degree of the immune response to Protective Antigen (PA), the major vaccine antigen. In the current study, the safety, tolerability, and antibody response to PA will be studied for four different combinations of AVA and CPG 7909, and compared to both AVA and a saline placebo. All formulations of AV7909 have the same or less AVA than the licensed AVA vaccine and all have less CPG 7909 per dose than the formulation used in the first Phase I volunteer study of CPG 7909 combined with AVA.

Conditions

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Bacillus Anthracis (Anthrax) Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BioThrax

BioThrax, 0.5 mL AVA per dose

Group Type ACTIVE_COMPARATOR

BioThrax

Intervention Type BIOLOGICAL

BioThrax

AV7909 Formulation 1

0.5 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose

Group Type EXPERIMENTAL

AV7909 Formulation 1

Intervention Type BIOLOGICAL

AV7909 Formulation 1

AV7909 Formulation 2

0.5 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose

Group Type EXPERIMENTAL

AV7909 Formulation 2

Intervention Type BIOLOGICAL

AV7909 Formulation 2

AV7909 Formulation 3

0.25 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose

Group Type EXPERIMENTAL

AV7909 Formulation 3

Intervention Type BIOLOGICAL

AV7909 Formulation 3

AV7909 Formulation 4

0.25 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose

Group Type EXPERIMENTAL

AV7909 Formulation 4

Intervention Type BIOLOGICAL

AV7909 Formulation 4

Control

Saline control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

Saline control

Interventions

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BioThrax

Intervention Type BIOLOGICAL

AV7909 Formulation 1

Intervention Type BIOLOGICAL

AV7909 Formulation 2

Intervention Type BIOLOGICAL

AV7909 Formulation 3

Intervention Type BIOLOGICAL

AV7909 Formulation 4

Intervention Type BIOLOGICAL

Control

Saline control

Intervention Type DRUG

Other Intervention Names

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Anthrax Vaccine Adsorbed (AVA)

Eligibility Criteria

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Inclusion Criteria

* Be between 18 and 50 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.
* Have negative values for the following tests at Screening: Hepatitis C antibody, anti-Human Immunodeficiency Virus (Anti-HIV-1/-2/-O), and anti-Hepatitis B Core Antigen (Anti-HBc).
* Be willing and capable of complying with all aspects of the protocol through completion of the required visits.
* Have not donated blood in the preceding 8 weeks and are willing to not donate blood or plasma within 56 days after dosing.
* Have adequate venous access for repeat phlebotomies.
* Have read, understood and signed an informed consent form.

Exclusion Criteria

* A known anaphylactic response, severe systematic response, or serious hypersensitivity reaction to a prior immunization.
* Prior immunization with anthrax vaccine, recombinant Protective Antigen (rPA) vaccine, or known exposure to anthrax organisms.
* Have previously served in the military or plans to enlist in the military from Screening through Day 84.
* Have participated in anthrax therapeutic or vaccine trials (monoclonal anti-protective antigen (PA) or anthrax immune globulins or anthrax vaccines).
* Participation in any investigational clinical trial within 30 days preceding the Screening visit or planning to participate in a clinical trial requiring dosing through the Day 194 visit.
* A history of drug or alcohol abuse within 12 months prior to Screening, or a positive result on a urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, methylenedioxymethamphetamine opiates, oxycodone, phencyclidine, propoxyphene, or tricyclic antidepressants.
* Blood pressure greater than 145 millimeters of mercury (mmHg) systolic or 90 mmHg diastolic.
* Past history of significant autoimmune disease such as rheumatoid arthritis, lupus erythematous, psoriasis, glomerulonephritis, or autoimmune thyroiditis.
* 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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes