Acceptance criteria for declarations of intent

The expert judging panel, composed of federal employees, will accept declarations based on the official acceptance criteria. Judges will use a binary assessment (yes or no) to determine if the declaration meets each acceptance criterion described below. An entrant’s declaration should be accepted if the declaration meets the requirements of each criterion.

No data package should be submitted or screened at the declaration of intent step.

Concept Stage

The Concept Stage is open to all eligible entrants; no declaration of intent is required to participate. Please review Concept Stage evaluation page/section for detailed submission requirements.

Preclinical Stage

Product design

The declaration demonstrates that the proposed product meets the prize definition of a patch-based vaccine.

  • A patch is a vaccine delivery system that is applied to the body like a small adhesive disc or bandage, and consists of microscopic projections that penetrate the skin surface.
  • The combination product must be a single patch intended for intradermal RNA vaccine administration.
  • The vaccine product must include at least one of the following indications: COVID-19, trivalent or quadrivalent seasonal influenza, and/or pandemic influenza A/H5N1. The vaccine product may also target any other indications concurrently, as long as it includes at least one of the required indications listed above.

Preclinical development

The declaration describes all relevant preclinical study protocols in a 1-2 page synopsis that meets the requirements below.

  • The declaration demonstrates study protocols for evaluating antibody-inducing immune response after administering the product in one animal model.
    • Vaccines that do not induce antibodies, such as T-cell based vaccines, are out of scope for the Patch Forward Prize Preclinical Stage.
  • The declaration describes the entrant-defined functional immune assay(s) and corresponding success metrics for each assay.
    • Planned studies should demonstrate titers in the functional immune assay(s) that are comparable to existing vaccine(s), but do not need to include any testing of such vaccine(s). The success metrics should be clinically relevant and realistic to achieve. For example, an entrant may use hemagglutination inhibition (HAI) assay to demonstrate the vaccine formulation can generate a standard HAI titer at a threshold that indicates a clinically beneficial level of protection.
  • The declaration should include toxicology study protocols that will yield a detailed assessment of reactogenicity, evaluating redness, skin thickness, edema, itching, and other potential skin reactions.

Overall, the declaration proposes a satisfactory preclinical evaluation program of the proposed product.

Regulatory and risk-mitigation plan

No requirement for the declaration of intent step.

Manufacturing

The declaration includes an up to one page outline of the entrant’s current manufacturing capabilities and plans to initiate GMP process development and production in support of the preclinical and clinical trials.

The declaration includes processes and materials entrants plan to use to generate preclinical data. Entrants are highly encouraged to maintain consistency in materials and processes developed for preclinical studies and Phase I production.

  • The declaration includes a plan for evaluating the stability of the product from initial manufacturing through to administration, and post-administration of the product in animal models, or for a minimum of three months.

Operational readiness

The declaration demonstrates the entrant has access to intellectual property by providing a fully-executed letter of support or commitment to outline partnership between a vaccine developer and a patch maker.

  • The declaration proposes new work and does not include data, or any other forms of evidence to indicate the preclinical studies have been previously conducted or registered with any regulatory bodies in any countries.

Clinical Stage

Product design

The declaration demonstrates that the proposed product meets the prize definition of a patch-based vaccine. 

  • A patch is a vaccine delivery system that is applied to the body like a small adhesive disc or bandage, and consists of micro-projections that penetrate the skin surface. 
  • The combination product must be a single patch intended for intradermal RNA vaccine administration. 
  • The vaccine product must include at least one of the following indications: COVID-19, trivalent or quadrivalent seasonal influenza, and/or pandemic influenza A/H5N1. The vaccine product may also target any other indications concurrently, as long as it includes at least one of the required indications listed above.
  • Phase I studies must be conducted for the patch-based vaccine candidate, not for the vaccine or patch product individually. The studies should compare the product’s response rates to historical studies using qualified assays. 

Clinical development

The declaration includes optimized, entrant-defined functional assays, and establishes success metrics for each assay to effectively evaluate the product’s clinical performance.

The declaration provides a 1-2 page synopsis or outline of all relevant Phase I clinical trial protocols, including:

  • Primary and secondary endpoints, primary arms, recruitment population, inclusion and exclusion criteria, sample size, and other relevant study parameters.
  • The described Phase I study should be designed to: 
    • Establish an acceptable seroconversion rate, defined as ≥ 40% of trial subjects achieving seroconversion. Seroconversion is defined as: (1) for pandemic or seasonal influenza, subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer > 1:40 or a pre-vaccination HI titer > 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer and (2) for COVID-19, a minimum four-fold rise in the post-vaccination functional immune assay readout as compared to pre-vaccination (i.e., baseline) readout.
    • Address pre-specified endpoints in the clinical trial protocol to include safety monitoring and immunogenicity readout(s) for at least 6 months post-vaccination. The safety and reactogenicity readouts should use grading scales provided by the FDA.
    • Include evaluations of redness, skin thickness, edema, itching, and other potential skin reactions at the site of patch administration.

Regulatory and risk-mitigation plan

The declaration must demonstrate the entrant will commence a Phase I clinical study under an investigational new drug (IND) authorization.

Manufacturing

The declaration outlines the entrant’s current manufacturing capabilities and processes, and describes their plans to source cGMP-compliant materials for use in a Phase I clinical data.

The declaration includes processes and materials the entrant plan to use to generate Phase I data. Entrant should provide information on the consistency of manufacturing processes from material used in nonclinical studies to proposed GMP material to be used in a Phase I clinical study.

  • The declaration includes a plan for evaluating the stability of the product from the time of initial manufacturing, through to administration, and last administration of the product in humans, or for a minimum of six months.

Operational readiness

The declaration demonstrates the entrant has access to intellectual property by providing fully executed letters of support or commitment that outline partnerships between a vaccine developer and a patch maker.

The declaration proposes new work and does not include data — or any other forms of evidence — to indicate the clinical studies of the proposed product have been previously conducted or registered with any regulatory bodies, in the U.S. or abroad.

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