# Multivalent Adjuvant Immunization to Prevent Hospital Acquired Infections

> **NIH NIH R42** · EXBAQ LLC · 2022 · $995,098

## Abstract

PROJECT SUMMARY/ABSTRACT
Two million Healthcare Associated Infections (HAIs) occur per year in the US, killing >90,000 patients and
costing ~$50-100 billion (adjusted by CPI to 2020 dollars). HAIs are the 6th leading cause of death in the US,
ahead of diabetes and kidney disease. Reducing HAIs is a top priority of the US Department of Health and
Human Services1 and experts have called for novel strategies including vaccination to achieve this goal.2
 ExBaq is a biotechnology company founded by a consortium of scientists and business colleagues who
have spent years studying antibiotic-resistant nosocomial pathogens. ExBaq is developing a vaccine to
prevent HAIs comprised of innate-immune stimulatory molecules that provide broad-spectrum protection
against infection caused by cross-kingdom HAI pathogens (preliminary data). Our vaccine consists of:
 A) Aluminum hydroxide (Al(OH)3), which is contained in multiple FDA-approved vaccines, and
 enhances immunity via multiple mechanisms, including induction of depot formation, activating the
 NALP3 inflammasome, and enhancing particulate uptake by macrophages;
 B) Monophosphoryl Lipid A (MPL), which is also contained (in combination with Al(OH)3) in multiple
 FDA-approved vaccines and activates the NF-κB pathway via TLR4 ligation;
 C) Mannan, which stimulates a variety of innate and adaptive immune pathways, and was safe in
 clinical trials when administered parenterally.
 During Phase I we have confirmed that this triple adjuvant regimen has the broadest protection against
pathogens, affording lower doses (important for cost of goods), compared to a triple regimen containing whole
glucan particles instead of mannan, or with a quadruple regimen (preliminary data). Efficacy of the triple
regimen has been confirmed in lethal mouse models of carbapenem-resistant Acinetobacter baumannii and
Klebsiella pneumoniae, methicillin-resistant Staphylococcus aureus (MRSA), and disseminated infection
caused by the fungi Candida albicans and Rhizopus delamar (mucormycosis). Given efficacy against Gram-
positive and -negative bacteria and fungal pathogens, our trivalent vaccine has potential to prevent
HAIs caused by the highest priority, antibiotic-resistant nosocomial pathogens. Having established an
optimal lead composition in Phase I, the goal of Phase II is to establish GMP, conduct pre-clinical immuno-
toxicology studies, and to complete key steps to supporting IND submission. Our Aims are to:
AIM 1: Establish GMP manufacturing for our vaccine regimen.
AIM 2: To complete pre-clinical immuno-toxicity studies to support an IND application.
AIM 3: Complete key steps to support IND-filing at end of funding.

## Key facts

- **NIH application ID:** 10378255
- **Project number:** 2R42AI145759-03
- **Recipient organization:** EXBAQ LLC
- **Principal Investigator:** BRAD J SPELLBERG
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $995,098
- **Award type:** 2
- **Project period:** 2020-02-10 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10378255

## Citation

> US National Institutes of Health, RePORTER application 10378255, Multivalent Adjuvant Immunization to Prevent Hospital Acquired Infections (2R42AI145759-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10378255. Licensed CC0.

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