Clinical trial NCT01770743: A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
Official title: A Phase 2, Randomized, Parallel-Group, Active-Controlled, Double-Blind Study to Evaluate the Safety and Immunogenicity of AV7909 for Post-Exposure Prophylaxis of Anthrax Using Three Immunization Schedules and Two Dose Levels in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anthrax
Keywords: post-exposure prophylaxis
toxin neutralization assay
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2013-01-18
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.

Detailed description: The safety and immunogenicity of AV7909 for post-exposure prophylaxis of anthrax will be evaluated using a randomized, parallel-group, active-controlled, double-blind design with three immunization schedules and two dose levels in healthy adult volunteers. Safety will be assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis), monitoring of adverse events, vital signs, and physical examinations. Reactogenicity (systemic and injection site reactions) will be assessed by the subjects using subject e-diaries for 7 days after each immunization and by the investigator at in-clinic visits 7 and 14 days after each immunization, and at other visits, if applicable. Immunogenicity will be measured as toxin neutralizing antibody (TNA) response and seroconversion rates.

Eligibility criteria: Inclusion Criteria:

* Be 18-50 years old
* Be in good health
* Have access to a computer and the internet so you can complete a diary
* Agree to abstain from sex the first 84 days of the study or practice birth control if you are a woman who is able to get pregnant
* Have not donated blood for the previous 8 weeks

Exclusion Criteria:

* A known anaphylactic response, severe systemic response, or serious hypersensitivity reaction to a prior immunization.
* A history of latex allergy.
* Have received a shot (vaccine), including flu shots, in the past 6 weeks or plan to get a shot for 4 weeks after the last study shot is given.
* Have previously served in the military any time after 1990 or plan to enlist in the military from Screening through Day 84.
* Prior immunization with anthrax vaccine, recombinant protective antigen (rPA) vaccine, or known exposure to anthrax organisms.
* Have participated in anthrax therapeutic or vaccine studies (monoclonal anti-PA or anthrax immune globulins or anthrax vaccines).
* Participation in any investigational study involving use of a pharmacological intervention within 30 days before the Screening visit or planning to participate in a study requiring dosing through the 12-month safety follow-up telephone call.
* Have a known diagnosis of any immunodeficiency disease including but not limited to: acquired immune deficiency syndrome (AIDS), common variable immunodeficiency disease, immunoglobulin A (IgA) deficiency, or hypogammaglobulinemia.
* Past history of significant autoimmune disease such as rheumatoid arthritis, lupus erythematous, psoriasis in the area of vaccinations, or requires immunotherapy, glomerulonephritis, or autoimmune thyroiditis.
* Have received immunosuppressive therapy with cytotoxic drugs or Rituximab within the past 2 years.
* A history of cytotoxic chemotherapy or radiation therapy.
* Chronic (\>10 days) daily oral or parenteral corticosteroid therapy in the past 12 months.
* Any lung disease, including reactive airway disease, which requires the daily use of medications.
* A female currently breastfeeding or with a positive pregnancy test.
* A history of drug or alcohol abuse within 12 months prior to Screening, or a positive result on a urine drug screen for cocaine, marijuana, opiates, methamphetamines, benzodiazepines, or oxycodone.
* Any tattoo or other skin condition in the deltoid region on either arm that may obscure the assessment of the injection sites.
* A medical condition that, in the opinion of the PI or designee, could adversely impact the subject's participation or safety or the conduct of the study.
* Any planned elective in-patient surgery during the study period.

Primary outcomes:
measure: Toxin Neutralizing Antibody (TNA) Level at Day 63
timeFrame: Day 63
measure: Incidence of Adverse Events
timeFrame: From the time of the first immunization on Day 0 through Day 84
measure: Incidence of Serious Adverse Events
timeFrame: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
measure: Incidence of Reactogenicity By Severity
timeFrame: For 7 days following each vaccination on Days 0, 14, 28
measure: Incidence of Clinical Laborabory Abnormalities
timeFrame: From the time of first immunization on Day 0 to Day 84
measure: Incidence of Immunologically Significant Adverse Events of Special Interest
timeFrame: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
Secondary outcomes:
measure: TNA Level at Day 42
timeFrame: Day 42
measure: TNA Level at Day 28
timeFrame: Day 28
measure: TNA Seroconversion Rate
timeFrame: Up to Day 84
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Mount Pleasant
country: United States
facility: Costal Carolina Research
state: South Carolina
city: New Braunfels
country: United States
facility: Central Texas Allergy and Asthma
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Emergent BioSolutions
name: Gurdyal Kalsi, MD, MTOPRA
role: PRINCIPAL_INVESTIGATOR
References: