# An Avirulent Arthroconidial Vaccine Candidate to Prevent Human Coccidioidomycosis

> **NIH NIH R01** · UNIVERSITY OF ARIZONA · 2020 · $1,149,998

## Abstract

Abstract
 Coccidioidomycosis (Valley Fever) is a systemic infection caused by the fungi, Coccidioides immitis or
Coccidioides posadasii, which are endemic to Arizona, California and other parts of the United States. Illness
ranges from pneumonia to life-threatening spread to other parts of the body (disseminated infection),
including the brain. Valley Fever causes an average of 160 deaths annually, and produced $2 billion in
hospital charges from 2000 – 2011. Current therapies are not curative and may be need to be continued for
life. This proposal responds to RFA-AI-16-034 which explicitly invites vaccines for Coccidioides spp.
 Our vaccine candidate appears i) safe, ii) highly effective, and iii) feasible to produce commercially. It is
based upon a deletion of the CPS1 gene from the fungus, resulting in complete loss of virulence in mice.
When used as a vaccine against experimental murine coccidioidomycosis, it is very protective. The vaccine
candidate (∆cps1) is “manufactured” by simply growing arthroconidia on solid media and so the cost of goods
is likely to be low, making commercial development feasible. We propose to develop our vaccine candidate
first to prevent Valley Fever in dogs. This will provide pre-clinical information for its safety and efficacy in a
large animal and further support an FDA IND for humans. The specific aims are to first use fungal genetic
analysis of the CPS1 mutation to determine why it is essential for virulence. A complete understanding of its
role in the fungus could provide a better assessment about its safety as a live vaccine. Second, we will
develop a formulation that would be used in both dogs and humans. Third, we will determine exactly which
lymphocyte subsets and their cytokines mediate protection. This information will be useful for the rational
identification of future surrogate markers of protection in immunized dogs and humans. Finally, we will develop
an experimental model of coccidioidal infection in canines and use it to test the efficacy of ∆cps1 to prevent
disease.
 In addition to the studies proposed in this application, we have identified an industrial partner, Anivive
Lifesciences, that has agreed to partner with us and will provide additional investment and expertise to fully
develop a veterinary vaccine. We believe that with the success of this program, risk of developing our vaccine
candidate for humans will be substantially reduced to the point that further investment will be forthcoming to
complete the ultimate objective of our work.

## Key facts

- **NIH application ID:** 9969314
- **Project number:** 5R01AI132140-04
- **Recipient organization:** UNIVERSITY OF ARIZONA
- **Principal Investigator:** JOHN N GALGIANI
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,149,998
- **Award type:** 5
- **Project period:** 2017-08-07 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969314

## Citation

> US National Institutes of Health, RePORTER application 9969314, An Avirulent Arthroconidial Vaccine Candidate to Prevent Human Coccidioidomycosis (5R01AI132140-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9969314. Licensed CC0.

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