A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels

NCT ID: NCT01770743

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Anthrax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

AV7909 (Day 0 and 14)

Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14

Group Type: EXPERIMENTAL

AV7909

Intervention Type: BIOLOGICAL

Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant

AV7909 (Day 0 and 28)

Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28

Group Type: EXPERIMENTAL

AV7909

Intervention Type: BIOLOGICAL

Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant

AV7909 (Day 0, 14, and 28)

Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28

Group Type: EXPERIMENTAL

AV7909

Intervention Type: BIOLOGICAL

Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant

AV7909 Reduced Dose

Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28

Group Type: EXPERIMENTAL

AV7909

Intervention Type: BIOLOGICAL

Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant

BioThrax

Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28

Group Type: ACTIVE_COMPARATOR

BioThrax

Intervention Type: BIOLOGICAL

Interventions

AV7909

Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant

Intervention Type: BIOLOGICAL

BioThrax

Intervention Type: BIOLOGICAL

Other Intervention Names

AV7909 Anthrax Vaccine; NuThrax; Anthrax Vaccine Adsorbed (AVA)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gurdyal Kalsi, MD, MTOPRA

Role: PRINCIPAL_INVESTIGATOR

Emergent BioSolutions

Locations

Miami Research Associates

Miami, Florida, United States

Costal Carolina Research

Mt. Pleasant, South Carolina, United States

Central Texas Allergy and Asthma

New Braunfels, Texas, United States

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

HHSN272201000035C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EBS.AVA.208 / DMID 11-0055

Identifier Type: -

Identifier Source: org_study_id