Task Order (Under BARDA MCM CSN Contract): Phase 2 Clinical Study to Assess the Safety and Immunogenicity of Anthrax Vaccine Adsorbed (BioThrax™) without and with CpG 7909 Adjuvant (AV7909 Anthrax Vaccine) in Individuals over 65
Sponsor: Department of Health and Human Services (HHS)/Office of the Assistant Secretary for Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA)
Project Status: Active
Project Start and End Dates: September 2017 – November 2019
Disease: Anthrax is a serious infectious disease caused by bacteria known as Bacillus anthracis. People become infected with anthrax when they breathe in spores, eat food or drink water that is contaminated with spores, or get spores in a cut or scrape in the skin. Additionally, people can get sick with anthrax if they come into contact with infected animals or contaminated animal products, although such instances are rare in the United States. In addition, Bacillus anthracis is one of the most likely agents to be used in a bioterrorist attack. As a result, people at the highest risk for anthrax include those who work with animals and animal-based products, military personnel, and postal workers.
Objective: Due to the potential of a bioterrorist attack with anthrax, one of BARDA’s goals is to develop countermeasures against anthrax. The only approved vaccine for anthrax is licensed for use in adults 18 through 65 years of age. To address this population gap, BARDA’s goal for this trial is to assess the safety and immunogenicity of investigational anthrax vaccines using a post-exposure prophylaxis dosing regimen in an elderly population.
Project Information: This randomized, phase 2, active-controlled, double-blinded, multi-site trial was designed to assess the safety and immunogenicity of BioThrax or AV7909 administered to adults aged 66 years and older compared with subjects aged 18 through 50 years. The trial will enroll up to 300 evaluable subjects (200 aged 66 years and older and 100 aged 18 through 50 years). Rho is providing comprehensive clinical research operations support for protocol and informed consent development; regulatory submissions and consulting; investigational product management, including developing an internal randomization and kit assignment system, as well as defining kitting, labeling, and distribution processes for the investigational product services vendor; site selection and clinical monitoring; operational document creation; all-inclusive data management, from establishing an electronic data capture system to collection, validation, management, and archival of the clinical data; statistical analysis; pharmacovigilance and medical monitoring; maintenance of an electronic trial master file per the TMF Reference Model; logistical and statistical support for the safety monitoring committee; quality assurance and oversight; and clinical study report authorship.
The 4 U.S. sites will recruit 300 volunteers in stable health from May through September 2018. Each subject will be randomized to a treatment group on Day 1 and will receive a series of 3 vaccinations (Day 1, Day 15, and Day 29). Subjects will be followed for immunogenicity and safety assessments through Day 394. An interim analysis to assess the immunogenicity and safety data is planned once all subjects complete Day 64. The trial expects to report on full immunogenicity and safety data in early 2020.
- Biostatistics and Statistical Programming
- Clinical Project Management
- Site Selection and Management
- Protocol Design/Development
- Safety Monitoring/Pharmacovigilance
- Data Management and Analysis
- Manuscript and Regulatory Document Development and Submission
- Organizational and Logistical Support, Including Meeting Coordination
- Study Website Content Development and Maintenance
- Study-Related Approvals, Including IRB Submissions
- Training and Training-Related Activities
- Biospecimen Collection Kit/Supplies Management and Tracking
- Process Documentation Development (e.g., SOPS)
- Investigational Product Management
- Quality Assurance
- Interactive Web Response System for Randomization and Kit Assignment