What Services Are Provided?
The Vaccine Development Services is intended for use in the investigation, control, prevention, and treatment of a wide range of infectious agents other than HIV. The Vaccine Development Services supports the following products: vaccines, vaccine components including adjuvants, vaccine delivery systems, other biologics, and BSL-2, BSL-3, and BSL-4 challenge material.
The suite of services provided by the Vaccine Development Services includes
- Vaccine Testing Services
- Assay Development for Non-Clinical and Clinical Samples
- Non-Clinical Immunogenicity and Efficacy Studies
- Clinical and Non-Clinical Sample Testing
- Safety and Toxicity Testing
- Vaccine Manufacturing Services
- Feasibility, Gap Analysis, and Product Development Plan Support
- Process Development
- Product Release Assay Development including Potency Assays
- Pilot and cGMP Manufacture
- Audits
- Regulatory Activities and Documentation
As appropriate, studies may be conducted in compliance with GLP (Good Laboratory Practice) and cGMP (Current Good Manufacturing Practice).
Note: Resources are limited and intended to fill critical gaps and are not to be the sole source of product development. Preliminary data to support program participation are required.
Eligibility Criteria and Preliminary Data Required
You may request services if you are an investigator in academia, a not-for-profit organization, industry, or government worldwide. You need not be a grantee of NIAID or another National Institutes of Health Institute or Center. However, you must have appropriate preliminary data to support advancing the product you wish to have studied to the requested stage of the product development pathway.
Please contact the appropriate staff contact in the Division of Microbiology and Infectious Diseases to discuss the preliminary data required in order to derive meaningful data from the studies you propose.
Assurances to Requestors
A Non-Clinical Evaluation Agreement (NCEA), with an attached Service Request Form (SRF), between NIAID and the requestor shall be required. The NCEA protects the requestor’s intellectual property and ensures confidentiality.
The contract establishes confidentiality for all information flowing from NIAID to the contractor. Therefore, additional material transfer agreements between the requestor and the contractor are not needed. All information provided to the contractor will be treated as confidential.
Application and Approval Process
Step 1 – Discuss the potential request informally
Contact the appropriate staff contact in the Division of Microbiology and Infectious Diseases to discuss your preliminary data and the suitability of your proposed studies for support. Your request will be evaluated as follows:
- Are the proposed studies within the DMID/NIAID mission?
- Are the proposed studies within the scope of and/or technology provided by awarded contracts?
- Are a sufficient quality and/or quantity of product available?
- Are the proposed studies in compliance with animal welfare regulations?
- Is the proposed work supported by other funding sources/available from other sources?
- Has the requestor previously used DMID resources for assessment of the same or similar product? (Repeat use of DMID resources may be undertaken with strong justification.)
- Are preliminary data adequate to support the request to advance the product to the next step in the product development pathway?
- What is the likelihood that services will contribute significantly to the eventual development and/or evaluation of a product of high quality?
- What is the purported public health impact?
- What improvements in health benefits offered beyond current measure(s)?
- Does the requestor have a plan for advancing the product beyond completion of the services requested?
Informal requests are reviewed and approved at the Branch/Office level, where they are considered in relation to Branch/Office priorities.
Step 2 – Submit a formal proposal (by invitation only)
If your proposal is judged to be promising, DMID staff will invite you to submit a formal request for approval through the DMID Preclinical Services for Researchers site. DMID staff will provide instructions for establishing the NIH account required to access this site, instructions for submitting your Request, and a brief description of what to expect next.
Formal requests are reviewed and approved by the DMID senior leadership, where they are considered in relation to Division priorities.
Requestor Requirements
Requestors must update the DMID staff on all on-going studies and development status involving submitted product(s). Requestors must also provide abstracts, draft publications, press releases and other materials prior to submission to journals, conferences, or other public release of information. Communications should acknowledge the role that access to preclinical services provided by the Vaccine Development Services program played in furthering the research being reported.