NIH awards $6.6M for gonorrhea vaccine development, focusing on novel intranasal delivery

Contract Overview

Contract Amount: $6,612,767 ($6.6M)

Contractor: Intravacc B.V.

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-21

End Date: 2026-12-30

Contract Duration: 1,561 days

Daily Burn Rate: $4.2K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 10

Pricing Type: COST NO FEE

Sector: R&D

Official Description: DEVELOPMENT OF AN INTRANASAL VACCINE AGAINST GONORRHEA BASED ON OUTER MEMBRANE VESICLES COMBINED WITH SUSTAINED-RELEASE MICROSPHERES CONTAINING RECOMBINANT HUMAN INTERLEUKIN-12.

Plain-Language Summary

Department of Health and Human Services obligated $6.6 million to INTRAVACC B.V. for work described as: DEVELOPMENT OF AN INTRANASAL VACCINE AGAINST GONORRHEA BASED ON OUTER MEMBRANE VESICLES COMBINED WITH SUSTAINED-RELEASE MICROSPHERES CONTAINING RECOMBINANT HUMAN INTERLEUKIN-12. Key points: 1. Contract focuses on innovative intranasal vaccine delivery, a less common but potentially more effective method. 2. The research aims to address the growing threat of antibiotic-resistant gonorrhea. 3. Funding supports the development of a vaccine utilizing outer membrane vesicles and sustained-release micro-spheres. 4. The project aligns with public health priorities for infectious disease prevention. 5. Contract duration extends over four years, indicating a phased research and development approach. 6. The chosen contract type (Cost No Fee) is typical for early-stage research where outcomes are uncertain.

Value Assessment

Rating: fair

The contract value of $6.6 million for a four-year research and development project appears reasonable given the scope of developing a novel vaccine. Benchmarking is difficult without specific details on comparable intranasal vaccine development projects. However, the Cost No Fee structure suggests that the government is primarily covering the costs incurred by the contractor, with no additional profit margin, which can be cost-effective for high-risk research.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple offerors had the opportunity to bid. The presence of 10 bids suggests a competitive environment for this research area. This level of competition is generally positive for price discovery and ensuring the government receives competitive proposals.

Taxpayer Impact: A competitive process helps ensure that taxpayer funds are used efficiently by driving down costs and encouraging innovative solutions from multiple research institutions.

Public Impact

The primary beneficiaries are public health initiatives aimed at combating sexually transmitted infections. The research delivered will be a novel intranasal vaccine candidate against gonorrhea. Geographic impact is national, supporting NIH's mission to improve health across the United States. Workforce implications include support for researchers, scientists, and technicians in the biotechnology and pharmaceutical sectors.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for long development timelines and uncertain efficacy of novel vaccine technologies.
Reliance on specific scientific approaches (OMVs and microspheres) may limit adaptability if initial research proves challenging.

Positive Signals

Addresses a critical public health need for a gonorrhea vaccine.
Utilizes innovative intranasal delivery, potentially offering advantages over traditional methods.
Competitive award process suggests a robust evaluation of proposed research.

Sector Analysis

This contract falls within the Biotechnology and Life Sciences sector, specifically focusing on vaccine development. The market for vaccine R&D is substantial, driven by both public health needs and commercial opportunities. Comparable spending benchmarks are difficult to establish precisely without knowing the stage and specific technology, but significant federal investment is directed towards infectious disease research and vaccine innovation.

Small Business Impact

There is no indication of a small business set-aside for this contract. Given the nature of advanced vaccine research, it is likely that larger research institutions or specialized biotechnology firms were the primary bidders. Subcontracting opportunities for small businesses may arise if the prime contractor requires specialized services or materials.

Oversight & Accountability

Oversight is provided by the National Institutes of Health (NIH), a component of the Department of Health and Human Services. The contract type (Cost No Fee) implies rigorous financial oversight to ensure costs are reasonable and allowable. Transparency is maintained through public contract databases and NIH's research reporting requirements.

Related Government Programs

National Institute of Allergy and Infectious Diseases (NIAID) vaccine research programs
Centers for Disease Control and Prevention (CDC) STI prevention initiatives
Department of Defense vaccine research

Risk Flags

Novel technology risk
Efficacy uncertainty
Regulatory hurdles
Antibiotic resistance evolution

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $6.6 million to INTRAVACC B.V.. DEVELOPMENT OF AN INTRANASAL VACCINE AGAINST GONORRHEA BASED ON OUTER MEMBRANE VESICLES COMBINED WITH SUSTAINED-RELEASE MICROSPHERES CONTAINING RECOMBINANT HUMAN INTERLEUKIN-12.

Who is the contractor on this award?

The obligated recipient is INTRAVACC B.V..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $6.6 million.

What is the period of performance?

Start: 2022-09-21. End: 2026-12-30.

What is the track record of INTRAVACC B.V. in developing vaccines, particularly those using similar technologies?

INTRAVACC B.V. is a spin-off from the University of Utrecht and has a focus on developing novel vaccine technologies. They have been involved in developing vaccines for various diseases, including influenza and RSV, often exploring different delivery platforms. Information regarding their specific experience with outer membrane vesicles (OMVs) combined with sustained-release micro-spheres for intranasal delivery would require a deeper dive into their project portfolio and publications. Their history suggests a capacity for innovative vaccine research, but the success of this specific approach will be a key indicator. Further investigation into their clinical trial history and regulatory approvals for previous vaccine candidates would provide a more comprehensive view of their capabilities and past performance.

How does the $6.6 million funding compare to other federal investments in gonorrhea vaccine research?

Directly comparing this $6.6 million award to other federal investments in gonorrhea vaccine research requires access to comprehensive federal spending databases and specific project details. However, it is known that federal agencies like the NIH and CDC allocate significant funds towards infectious disease research, including STIs. Gonorrhea, due to rising antibiotic resistance, is a priority area. While $6.6 million over four years is a substantial sum for a single R&D project, it represents a portion of the overall federal commitment. Other projects might receive similar or larger funding depending on their stage (e.g., clinical trials vs. early development) and the specific technologies being pursued. The 'Cost No Fee' contract type suggests this funding is primarily for direct research costs rather than encompassing large profit margins, making it an efficient allocation for early-stage development.

What are the primary risks associated with developing an intranasal vaccine for gonorrhea?

Developing an intranasal vaccine for gonorrhea presents several key risks. Firstly, the efficacy of intranasal delivery for inducing systemic immunity against a pathogen like *Neisseria gonorrhoeae*, which primarily infects mucosal surfaces, needs to be thoroughly established. While intranasal vaccines can offer advantages like ease of administration and potential for mucosal immunity, achieving the right balance of immune response is critical. Secondly, the stability and immunogenicity of the proposed vaccine components (outer membrane vesicles and recombinant human interleukin-12) are subject to research uncertainties. The development of antibiotic resistance in gonorrhea means the pathogen is evolving, posing a challenge for any vaccine candidate's long-term effectiveness. Finally, the path to regulatory approval for a novel vaccine platform like this can be lengthy and complex, involving rigorous safety and efficacy testing.

What is the potential impact of this research on public health if successful?

If successful, this research could have a significant positive impact on public health by providing a much-needed tool to combat gonorrhea, a sexually transmitted infection that is increasingly difficult to treat due to antibiotic resistance. An effective vaccine could reduce the incidence of gonorrhea infections, thereby lowering associated health complications such as pelvic inflammatory disease, infertility, and ectopic pregnancies. Furthermore, a reduction in gonorrhea cases would lessen the overall burden on healthcare systems and potentially slow the spread of other STIs. The intranasal delivery method, if proven effective and user-friendly, could also improve vaccine uptake and accessibility, contributing to broader public health goals for STI prevention and control.

How does the 'Cost No Fee' contract type influence the contractor's incentives and the government's risk?

The 'Cost No Fee' (CNF) contract type is typically used for research and development efforts where the outcome is highly uncertain and the government's primary goal is to fund the necessary research activities. Under a CNF contract, the contractor is reimbursed for all allowable costs incurred in performing the work, but receives no fee or profit. This structure aligns the contractor's incentives with efficient cost management, as they are not motivated by profit maximization but rather by successfully completing the research objectives within the allocated budget. For the government, this contract type minimizes financial risk related to contractor profit margins, ensuring that funds are primarily directed towards the research itself. However, it places the burden of managing research risks and achieving scientific milestones squarely on the contractor, with the government's primary recourse being the termination of the contract if progress is unsatisfactory.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: 2021-1

Offers Received: 10

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: ANTONIE V LEEUWENHOEKLN 9, BILTHOVEN

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Foreign Owned, Not Designated a Small Business, Special Designations

Financial Breakdown

Contract Ceiling: $14,613,141

Exercised Options: $6,612,767

Current Obligation: $6,612,767

Actual Outlays: $3,639,902

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline