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Adjuvant Development for Vaccines and for Autoimmune and Allergic Diseases


Fast-Track proposals will be accepted Number of anticipated awards: 1-3 Budget (total costs):
Phase I: $300,000/year for up to 2 years
Phase II: $1,000,000/year for up to 3 years
Adjuvants stimulate innate and/or adaptive immune responses. For the purpose of this SBIR, vaccine adjuvants are defined
according to the U.S. Food and Drug Administration (FDA) as “agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen”. Tolerogenic adjuvants are defined as compounds that promote immunoregulatory or immunosuppressive signals to induce non-responsiveness to self-antigens in autoimmune diseases, or environmental antigens in allergic diseases. Currently, only three adjuvants have been approved for clinical use as components of vaccines in the United States -aluminum hydroxide/aluminum phosphate (alum), 4’-monophosphoryl lipid A (MPL), adsorbed to alum as an adjuvant for an HPV vaccine, and the oil-in-water emulsion MF59 as part of the FLUAD influenza vaccine for people age 65 years and older. Additional efforts are needed to more fully develop the potential capabilities of promising adjuvants, particularly for special populations such as the young, elderly and immune-compromised. In addition, adjuvants may facilitate the development of immunotherapeutics for immune-mediated diseases, such as allergen immunotherapy to treat/prevent immune-mediated diseases (e.g., allergic rhinitis, asthma, food allergy, autoimmunity, transplant rejection). The field of tolerogenic adjuvants is still in its infancy. No compounds have been licensed yet in the US and immune-mediated diseases continue to be treated mostly with broadly immunosuppressive drugs or long-term single or multi-allergen immunotherapy. In contrast to drugs, tolerogenic or immunomodulatory adjuvants would interfere with immune responses to specific antigens through a variety of mechanisms which include the induction of regulatory T cells, or by changing the profile of the pathogenic lymphocyte response (e.g., Th1 to Th2 or vice versa). The combination of tolerogenic adjuvants with allergen immunotherapy should aim at accelerating tolerance induction, increasing the magnitude of tolerance, and decreasing the duration of treatment.
Project Goal
The goal of each project is to accelerate pre-clinical development and optimization of a single lead adjuvant candidate or a select combination-adjuvant for prevention of human disease caused by infectious pathogens, or for autoimmune or allergic diseases. For this solicitation, a combination-adjuvant is defined as a complex exhibiting synergy between individual adjuvants, such as: overall enhancement or tolerization of the immune response; potential for adjuvant-dose sparing to reduce reactogenicity while preserving immunogenicity or tolerizing effects; or broadening of effector responses, such as through target-epitope spreading or enhanced antibody avidity. The adjuvant products supported by this program may be studied and further developed toward human licensure with currently licensed or new investigational vaccines, and/or may be developed as stand-alone immuno-stimulatory or immuno-regulatory agents.
Phase I Activities
Depending on the developmental stage at which an adjuvant is entered into the Program, the offeror may choose to perform one or more of the following:
 Optimization of one candidate compound for enhanced safety and efficacy. Studies may include:
 Structural alterations of the adjuvant or modifications to formulation; or
 Optimization of heterologous prime-boost-regimens
 Development of novel combinations of previously described individual adjuvants, including the further
characterization of an adjuvant combination previously shown to enhance or tolerize immune responses
synergistically and/or additively
 Establishment of an immunological profile of activity and immunotoxicity that can be used to evaluate the capability of the adjuvant to advance to human testing

DB pathway in
 Preliminary studies in a suitable animal model to evaluate the protective or tolerizing efficacy of a lead adjuvant:vaccine  Analysis of vaccine efficacy through the use of a combination adjuvant and studies to evaluate the safety profile of the combination adjuvant:vaccine-formulation
Phase II Activities
Extended pre-clinical studies that may include IND-enabling studies such as:
 Additional animal testing of the lead adjuvant:vaccine combination to evaluate immunogenicity or tolerance
induction, protective efficacy and immune mechanisms of protection
 Pilot lot or cGMP manufacturing of adjuvant or adjuvant:vaccine
 Advanced formulation and stability studies
 Toxicology testing
 Establishment of quality assurance and quality control protocols
 Pharmacokinetics/absorption, distribution, metabolism and excretion studies
This SBIR will not support:
 The further development of an adjuvant that has been previously licensed for use with any vaccine
 The conduct of clinical trials (see
0.pdf for the NIH definition of a clinical trial)
 The discovery and initial characterization of adjuvant candidates
 The development of adjuvants or vaccines to prevent or treat cancer
 Development of platforms, such as vehicles, or delivery systems that have no immunostimulatory or tolerogenic
activity themselves
 The discovery, development and/or optimization of an immunogen component of a vaccine

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