The primary mission of the VRC Clinical Trials Core (CTC) is to evaluate candidate HIV vaccines in Phase I clinical trials. A secondary mission is to evaluate candidate vaccines for Biodefense and Re-Emerging Infectious Diseases.

The goals of the CTC are to:

• Advance promising vaccine candidates into human trials
• Optimize volunteer safety, confidentiality, knowledge, and convenience
• Maintain Good Clinical Practice standards exceeding requirements mandated in 21 CFR part 11, including compliance with all regulatory agencies and committees as outlined in 45 CFR part 46
• Design protocols that achieve clinical development objectives in a scientifically rigorous and time efficient manner
• Organize the operational aspects of clinical protocols to optimize volunteer safety and minimize length of study
• Collect and maintain high quality clinical data
• Collect and distribute high quality clinical samples
• Collect demographic, behavioral, and marketing data to inform recruitment efforts
• Perform integrated analyses of clinical and immunological data, and prepare clinical trial data for presentation and publication
• Provide community education and support to local organizations
• Provide guidance and assistance to other groups involved in vaccine evaluation
• Interface internally with VRC production, regulatory, administrative, and laboratory groups, and externally with extramural NIAID, clinical trial networks, regulatory agencies, international organizations, and industry partners to achieve efficient transitions through each stage of the clinical development process
• Train physician-scientists in the science of vaccinology
• Conduct clinical trials of therapeutic immunization using preventive vaccine candidates.

To accomplish these goals, the CTC is organized into three major sections: 1. protocol development and management, 2. recruitment and outreach, and 3. clinical operations. The sections are interdependent and work in harmony to accomplish all the tasks required to complete and advance the clinical trials.