HIV/AIDS

Guidelines for Requesting Access to Animal Models and Vaccine Reagents

Guidelines for Submission of Data Accompanying Requests for Assistance

General Information

• Investigator's name, institution, address, telephone and fax numbers, and e-mail address
• Title and number of current research grant or contract supported by NIH (if any)
• Rationale and supporting data for requesting assistance through DAIDS resources

Requests for Existing Vaccine Reagents

• See NIH AIDS Research and Reference Reagent Program

Requests for Production of Vaccine Reagents

• Specific reagent (e.g., expressed proteins, monoclonal antibody expansion, others) and how will it support the investigator's research or vaccine development plan
• Known biological and physical characteristics
• Any known purification procedures and likely yields at each step
• Proposed mechanism of expression, expansion
• Summary of experimental results to date (provide methodologies)
• Discussion of patent and/or licensing position for GMP-compliant work

Requests for Use of Nonhuman Primates at Simian Vaccine Evaluation Units (SVEUs)

1. In vivo titrations of virus challenge stocks
   Requests should include:
   • Identification and source of virus, and cells used to generate the stock
   • Number of vials of stock available
   • In vivo data on levels and duration of virus replication
   • In vivo data on pathogenicity (if any)
   • In vitro titration data
   • Number and species of nonhuman primates requested for the titration
   • Infection route to be used for the titration
   • Description of vaccine studies which will use the virus for challenge
   • Scientific justification for the choice of the virus as a challenge stock
   • A statement of agreement to make the titered virus stock available to other researchers upon valid request
2. Pilot studies to obtain preliminary data on vaccine approaches, usually not previously evaluated in nonhuman primates
   Requests should include:
   • Scientific justification for the proposed study
   • Detailed description of the vaccine that is to be evaluated
   • Description of how the vaccine is produced
   • In vitro data supporting the quality of the vaccine
   • Preliminary data on immune responses in animals
   • An outline of the proposed study, including the number and species of primates being requested, the route(s), dose and schedule of delivery, the types of assays to be conducted to evaluate immune responses, the virus to be used for challenge (if any), the types of assays (if any) to be used to evaluate virus infection and replication level
3. Larger-scale studies to evaluate the efficacy of a vaccine approach in nonhuman primates
   Requests should include:
   • Scientific justification for the proposed study
   • Detailed description of the vaccine that is to be evaluated
   • Description of how the vaccine is produced and quality controlled
   • In vitro data supporting the quality of the vaccine
   • Information on the quantity of the vaccine available
   • Data on immune responses in non-human primates
   • Data on the efficacy of the vaccine in any other studies conducted in non-human primates
   • An outline of the proposed study, including the number and species of primates being requested, the route(s), dose and schedule of delivery, the types of assays to be conducted to evaluate immune responses, the virus to be used for challenge, the types of assays to be used to evaluate virus infection and replication level
   • Discussion of how this study will further the preclinical development plan for the vaccine
4. Requests for any other studies in non-human primates should include similarly detailed information
   Role of vaccine investigator in SVEU studies:
   • Studies conducted at SVEUs are collaborative. The vaccine investigator will be expected to participate, with the SVEU Principal Investigator and the SVEU Project Officer, in the design of the study and in discussion and evaluation of data and results.

Requests for Vaccine Development Resources (VDR)

1. GMP Vaccine Production
   • Background and description of candidate vaccine product.
   • Brief description of overall plan to move the candidate vaccine into phase I trials.
   • Scientific justification for the current proposal. Why should this particular design move into clinical trials? What does it offer beyond candidates already tested or soon to be tested?
   • Supportive evidence in favor of the vaccine candidate proposed.
     • Physical and biologic characteristics of vaccine product. Include information on purity, composition and stability of laboratory-produced material.
     • Production and purification methods.
     • Data on immune responses in small animals.
     • Proposed potency assay for ensuring production lot consistency.
     • Data on the efficacy of the vaccine in a non-human primate model (if available).
     • Any additional preclinical data available.
   • Detailed description of specific assistance requested. Propose goals, milestones and timeline for moving to Phase I trial.
2. GLP Production of Vaccine Products for Preclinical Studies
   • Description of product including biologic and physical characteristics.
   • Scientific justification for the current proposal. What does it offer beyond candidates already tested or soon to be tested?
   • How this product will support the investigator's research or vaccine development plan including description of preclinical trials and other uses for this product.
   • Description of production and purification methods. Include methods for determining potency of final product.
   • Summary of experimental results to date.
   • Detailed description of specific assistance requested.
3. Safety and Immunogenicity Studies of GMP Vaccine Products
   • Description of product.
   • Summary of plan for GMP production including manufacturer, milestones and timeline.
   • Lot release tests to be performed by manufacturer.
   • Summary of preclinical immunogenicity studies (antibody, CTL, etc.). Include data on proposed potency assay.
   • Summary of nonhuman primate studies (if any).
   • Detailed description of specific assistance requested.
4. FDA Submissions (IND)
   • Description of product.
   • Summary of plan for GMP production including manufacturer, milestones, and timeline.
   • Status of Investigator's Brochure, pre-IND meetings, etc.
   • Detailed description of specific assistance requested.