NIAID DAIDS Science HIV Vaccines HIV/AIDS Treatment HIV/AIDS Prevention NIAID Home
NEWS | OVERVIEW | GENERAL INFORMATION | FUNDING OPPORTUNITIES
SCIENCE | RESOURCES & LINKS | STATUS OF HIV VACCINE RESEARCH | VACCINE STUDIES | HIV VACCINE TRIALS NETWORK

Vaccine Pre-clinical Toxicology Testing

Vaccine Designs/Concepts

Correlates of Immunity

Assay Development

Animal Models

Immunologic Adjuvants

Variation

International Studies

Behavior

Ethics

Vaccine Design and Methodologic Issues

Assay Validation

Vaccine Pre-clinical Toxicology Testing

Previous - Brief Overview of Vaccine Manufacture | Next - Pre-clinical Safety Testing of Candidate Vaccines

Flowchart 2: Vaccine Manufacture

Flowchart 2: Vaccine Manufacture 1. Establish the manufacturing & controls, filling process ... 2. Establish mixing parameters to ensure homogeneity ... 3. Establish assays for lot release testing ... 4. Establish method for determining vaccine potency ... 5. Define test, method, and criteria for each bulk and filled lot of manufactured vaccine, Certification of Analysis (COA) ... 6. Establish stability under storage & conditions of use during shipping & dose administration ... Vaccine requirements for pre-clinical manufacturing and pre-IND meeting materials: Bulk Release COA CMC Release IND Manufacture sufficient quantity of vaccine to perform pre-clinical and stability testing and initial clinical trial(s) Bulk testing of manufactured product using identified assay methodologies Container/Closure, Labeling, Storage/Shipping and release conditions Fill vials for pre-clinical studies Testing & Release of lot Pre-clinical testing in animals COA and CMC documents Fill vials for clinical trial(s) Testing & Release of lot IND Submission


Navigation Contact Us Vaccine Home Site Map DAIDS Home NIAID Home Search NIAID
Last updated January 23, 2003 (cs)