NIAID Contract Opportunity To Develop a Novel Vaccine Adjuvant

Through the broad agency announcement (BAA) Vaccine Adjuvant Development Program in Infectious and Immune-Mediated Diseases, NIAID seeks offerors capable of advancing novel vaccine adjuvants towards licensure for human use. More specifically, we aim to fund milestone-driven programs to support the preclinical development and optimization of a single lead adjuvant for use in vaccines to prevent or treat human disease caused by non-HIV infectious pathogens or immune-mediated diseases.

The lead adjuvant may be a single entity [e.g., a single toll-like receptor (TLR) agonist], or a combination adjuvant (e.g., a TLR agonist combined with a saponin-based adjuvant). The adjuvants may be a chemical, biological, or genetic adjuvant (i.e., adjuvants encoded by RNA or DNA templates).

Adjuvants supported by this BAA are expected to be added to NIAID’s Vaccine Adjuvant Compendium.

Research Parameters

The proposal you submit in response to this BAA must include the following activities:

• Adjuvant formulation and optimization
• In vivo immunologic and efficacy studies in appropriate animal models
• Pharmacology and toxicology studies in appropriate animal models
• Vaccine stability studies

You may propose other activities as necessary to advance the adjuvant’s development. For example:

• Optimizing the adjuvant through structural alterations
• Evaluating the adjuvant when formulated with other adjuvants, as long as the other adjuvants meet requirements for adjuvants listed below
• Assessing immunization routes and dosing
• Evaluating the adjuvant for use in at-risk populations (e.g., neonates, elderly, immunocompromised)
• Conducting a pre-investigational new drug meeting with the FDA and incorporating guidance into the technical approach
• Developing and establishing master and working cell banks in compliance with current good manufacturing practices (cGMP)
• Chemistry, manufacturing, and control preclinical development, including process development activities to increase efficiency, yield, and quality while also reducing risk factors and manufacturing variability
• Pilot lot or cGMP production of the adjuvant or vaccine
• Establishing and implementing quality assurance and quality control protocols

Conversely, NIAID will not support the following activities through this BAA:

• Discovering or initially characterizing an adjuvant
• Conducting clinical trials
• Developing platforms technologies or delivery systems that have no immunostimulatory activity themselves
• Developing the vaccine’s antigen component or discovery of new antigens
• Developing immunostimulatory compounds or formulations as stand-alone immunotherapeutics (i.e., without a specific antigen or pathogen-specific vaccine component)

As for your proposed lead adjuvant, it must possess the following required characteristics:

• Previously demonstrated ability to augment, potentiate, or modulate an immune response to an antigen, using an in vivo model system, to enhance protective efficacy or drive therapeutic efficacy
• Previously shown to have immune stimulatory or modulating activity in human primary cells or tissues
• Not already used in any FDA licensed vaccine, with an exception permitting absorption to aluminum salts as a formulation activity
• Clearly defined intellectual property (IP), including:
  • Documented and guaranteed access to the adjuvant for you as the offeror
  • Appropriate IP protections or agreements in place or proprietary freedom to commercially develop the adjuvant

The adjuvant must be studied and further developed toward human licensure with currently licensed vaccines or as part of new investigational vaccines. You may not develop the adjuvant as a stand-alone agent.

You will choose the target non-HIV pathogen or immune-mediated disease as well as an appropriate vaccine target to advance the adjuvant’s development. Vaccines may be prophylactic or therapeutic. You can develop the adjuvant within the context of a single vaccine or as multiple vaccine candidates each targeting different pathogens, or allergens or antigens involved in immune-mediated diseases. The vaccine targets must be well-justified, and your choice of antigen(s) strongly supported by preliminary or published data.

You may develop the adjuvant within the context of a single or multiple vaccine platform technologies (e.g., recombinant protein, RNA, split vaccine). Your choice of vaccine platform(s) must be well-justified.

Solicitation Odds and Ends

Institutions and individuals may be substantially involved with more than one proposal (e.g., as the offeror for one proposal and a subcontractor for another, or as a subcontractor on multiple proposals). However, an individual may only serve as the principal investigator on one proposal submitted to this solicitation. Institutions may submit multiple proposals.

Contractors are expected to collaborate with other contractors awarded through this solicitation, including sharing of novel research reagents and other resources. Successful offerors will also share both positive and negative results to better guide adjuvant development activities across this program and the broader scientific community.

NIAID anticipates establishing three or four contract awards under this BAA.

We estimate the average annual total cost (direct and indirect costs combined) will be $1 to $2 million per award, but the actual total costs for each contract will depend on the scope of the project and the technical objectives of the award.

The proposed period of performance should not exceed five years, although the length of time for which you request funding should be consistent with the nature and complexity of your proposed research.

Proposals in response to the BAA are due on October 14, 2022, by 3 p.m. Eastern Time with awards made in or around September 2023.

If you have questions about the solicitation, contact Brandon de White at whitebra@niaid.nih.gov or 240-669-5149. Read the BAA itself for complete details.