# Preparation of a Phase I/II safety and efficacy trial for a cholera phage cocktail intervention

> **NIH NIH R34** · PHAGEPRO, INC. · 2024 · $173,300

## Abstract

Project Summary
The World Health Organization (WHO) estimates that approximately 1.3 billion people globally are at risk for
cholera, a severe diarrheal disease caused by the bacterium Vibrio cholerae that is spread through contaminated
water sources and substantial secondary person-to-person transmission. In 2022, the world saw a surge in the
number of cholera cases and associated deaths. Over 29 countries reported outbreaks with the highest recorded
global case fatality ratio of 1.9% (2.9% in Africa) in over a decade. Of note, 13 of these countries did not report
cases in 2021 and had not seen cases between 3 and 30 years, severely disrupting the disease elimination
goals of the WHO Global Taskforce for Cholera Control. Current prevention methods, such as the oral cholera
vaccine (OCV) and water, sanitation, and hygiene (WASH) campaigns, require significant investment of
resources and time for efficacy, but household contacts of cholera patients often present with cholera symptoms
two to three days after the initial patient becomes sick. In addition, the preventive use of antibiotics is not
recommended due to widespread resistance for cholera and other pathogens in the same environment. There
is a pressing need to develop a targeted clinical intervention to prevent the community spread of cholera using
a fast-acting prophylactic treatment. PhagePro aims to fill this gap with its product ProphaLytic-VcTM (PVC). PVC
is an orally administered bacteriophage (phage) cocktail comprised of Vibriophages ICP1, ICP2, and ICP3.
In this R34 clinical trial planning proposal, we aim to partner with cholera physicians and researchers at the
International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b) to plan for the first-in-human Phase
I/II trial for PVC to demonstrate safety and efficacy in household contacts of cholera patients. Phase I will test
once or twice daily oral doses of PVC, self-administered, for 7 days. Each arm will have 10 healthy adult
volunteers. After safety has been assessed, Phase II will commence with household contacts of cholera patients
with daily doses of either a placebo or PVC for 7 days. Each arm will have ~224 volunteers. We hypothesize
there will be at least a 43% reduction in cholera incidence among household contacts. To successfully implement
this trial, we will perform the following activities during the R34 grant.
First, we will develop clinical trial documentation such as the Clinical Protocol, Manual of Procedures,
Investigator’s Brochure, site management documents, data management plans, and tracking/monitoring
documents. In addition, we will recruit needed expertise such as biostatisticians, clinical operations associates,
quality control/assurance specialists, and Clinical Research Organizations to support these activities. Second,
we will develop a regulatory plan for administration of PVC in Bangladeshi volunteers, which involves submitting
materials to the icddr,b Institutional Review Board, Ethics R...

## Key facts

- **NIH application ID:** 10838235
- **Project number:** 1R34AI181650-01
- **Recipient organization:** PHAGEPRO, INC.
- **Principal Investigator:** Andrew Camilli
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $173,300
- **Award type:** 1
- **Project period:** 2024-07-17 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10838235

## Citation

> US National Institutes of Health, RePORTER application 10838235, Preparation of a Phase I/II safety and efficacy trial for a cholera phage cocktail intervention (1R34AI181650-01). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10838235. Licensed CC0.

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