Anthrax AV7909 Boost Evaluation Study

Summary

This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety and immune response kinetics of CYFENDUS™ (henceforth AV7909) administered on 2 primary series vaccination schedules followed by 6- and 12-month boosters.

Conditions

• Anthrax

Interventions

BIOLOGICAL

AV7909 Full Dose (0.5 mL)

AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for post-exposure prophylaxis (PEP) of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines.

BIOLOGICAL

AV7909 Half Dose (0.25 mL)

AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for PEP of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines.

BIOLOGICAL

Placebo: Sodium Chloride Injection, USP 0.9% (0.5 mL)

Sodium chloride 9 mg water for injection Quantum satis (q.s.). It contains no bacteriostat, antimicrobial agent, or added buffer. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment (pH 4.5-7.0).

BIOLOGICAL

Placebo: Sodium Chloride Injection, USP 0.9% (0.25 mL)

Sodium chloride 9 mg water for injection Quantum satis (q.s.). It contains no bacteriostat, antimicrobial agent, or added buffer. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment (pH 4.5-7.0).

Sponsors & Collaborators

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• ICON plc

  collaborator INDUSTRY

• Biomedical Advanced Research and Development Authority

  lead FED

Principal Investigators

• Derek Eisnor, MD · Biomedical Advanced Research and Development Authority

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-05

Primary Completion

2025-08-28

Completion

2026-08-31

FDA Drug

Yes

Countries

• United States

Study Locations