NCT07107516

Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers

Safety and Immunogenicity of PanChol, a Novel Live Attenuated Oral Cholera Vaccine, in Zambia Adults

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Centre for Infectious Disease Research in Zambia · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Cholera is a serious diarrheal disease that can be fatal within hours of onset. The current available cholera vaccines to prevent the disease are not very effective. Panchol is a new oral cholera vaccine that may be an improvement over the currently available vaccines in use. The goal of this study is to learn safety of this new oral cholera vaccine and the body's immune response to the vaccine. The researchers will compare the PanChol vaccine to placebo to see the side effects experienced in participants. The participants will be adults aged between 18 and 55 years and they will be required to: 1. Be admitted to hospital until they stop passing the cholera vaccine in their stool. During admission, all side effects will be recorded by the researchers. 2. After discharge, the participants will visit the research site every month for 3 months with an optional visit at the 4th month for the researchers to assess the participants' general health.

Conditions

• Cholera Vaccination Reaction

Interventions

Type	Name	Description
BIOLOGICAL	PanChol	Panchol is a novel live attenuated oral cholera vaccine. It is the first vaccine created with the variant El Tor background that is predominant in the world today. The vaccine has ten different genetic modifications to minimize reactogenicity but maintain the ability to colonize the intestine.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-08-06
• Last updated: 2025-08-24

Locations

1 site across 1 country: Zambia

Regulatory

• FDA-regulated drug study