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

Emergent BioSolutions

Status and phase: Completed; Phase 1

Conditions: Bacillus Anthracis (Anthrax) Infection

Treatments: Biological: AV7909 Formulation 4; Biological: AV7909 Formulation 3; Biological: AV7909 Formulation 1; Biological: AV7909 Formulation 2; Biological: BioThrax; Drug: Control

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency; NIH

Identifiers

NCT01263691

HHSN272200800051C (Other Grant/Funding Number)

EBS.AVA.201 / DMID 10-0013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Key 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 6 patient groups, including a placebo group

BioThrax

Active Comparator group

Description:

BioThrax, 0.5 mL AVA per dose

Treatment:

Biological: BioThrax

AV7909 Formulation 1

Experimental group

Description:

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

Treatment:

Biological: AV7909 Formulation 1

AV7909 Formulation 2

Experimental group

Description:

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

Treatment:

Biological: AV7909 Formulation 2

AV7909 Formulation 3

Experimental group

Description:

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

Treatment:

Biological: AV7909 Formulation 3

AV7909 Formulation 4

Experimental group

Description:

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

Treatment:

Biological: AV7909 Formulation 4

Control

Placebo Comparator group

Description:

Saline control

Treatment:

Drug: Control