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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT01263691
First received: December 17, 2010
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Bacillus Anthracis (Anthrax)
Biological: Anthrax Vaccine Adsorbed (AVA)
Biological: AV7909 Formulation 1
Biological: AV7909 Formulation 2
Biological: AV7909 Formulation 3
Biological: AV7909 Formulation 4
Drug: Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Parallel-arm, Double-blind, Randomized, Placebo-controlled, Dose-ranging Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of AV7909 in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Emergent BioSolutions:

Primary Outcome Measures:
  • Safety, as evaluated by adverse events and clinical laboratory tests [ Time Frame: Visits at Days 0, 1, 2, 7, 14, 21, 35, 42, 70, and 84 ] [ Designated as safety issue: Yes ]
    Sequential assessments of symptoms, physical exam findings, and clinical laboratory tests.


Secondary Outcome Measures:
  • Immunogenicity four AV7909 formulations, compared with saline placebo and anthrax vaccine adsorbed (AVA) alone [ Time Frame: Visits through Day 84 after first immunization ] [ Designated as safety issue: No ]
    Anti-protective antigen (PA) antibody responses measured by anti-PA IgG and by the toxin neutralization assay (TNA).


Enrollment: 105
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AVA alone
AVA 0.5 mL
Biological: Anthrax Vaccine Adsorbed (AVA)
AVA alone
Experimental: AV7909 Formulation 1 Biological: AV7909 Formulation 1
AV7909 Formulation 1
Experimental: AV7909 Formulation 2 Biological: AV7909 Formulation 2
AV7909 Formulation 2
Experimental: AV7909 Formulation 3 Biological: AV7909 Formulation 3
AV7909 Formulation 3
Experimental: AV7909 Formulation 4 Biological: AV7909 Formulation 4
AV7909 Formulation 4
Placebo Comparator: Control
Saline control
Drug: Control
Saline control

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263691

Locations
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Emergent BioSolutions
Investigators
Study Director: Edward Bernton, MD Emergent Biosolutions, Inc.
  More Information

No publications provided

Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT01263691     History of Changes
Other Study ID Numbers: EBS.AVA.201 / DMID 10-0013, HHSN272200800051C
Study First Received: December 17, 2010
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Emergent BioSolutions:
AVA
AV7909
Anthrax vaccine

Additional relevant MeSH terms:
Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014