Not Yet RecruitingPhase 1

Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers

Zambia32 participantsStarted 2025-10-01

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Must have given written informed consent (signed and dated) and any other authorizations required by local law and be able to comply with all study requirements.
✓. Healthy adults aged from 18 to 55 years old.
✓. Considered healthy, as judged by the clinical investigator, according to medical history, physical examination, vital signs, screening laboratories, and medication history.
✓. Capable of understanding, consenting, and complying with the entire study protocol including the inpatient period.
✓. Female participants must be non-pregnant and non-lactating and either
✓. surgically sterile (history of bilateral ligation, bilateral salpingectomy, bilateral oophorectomy, total hysterectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months before screening without an alternative medical cause)
✓. be of child-bearing potential and practicing an acceptable method of contraception or abstaining from all activities that could result in pregnancy for at least 28 days before vaccination until 3 months after receiving the investigational product.

Exclusion criteria

What they're measuring

vaccine safety

Timeframe: 14 days after vaccination

Trial details

NCT IDNCT07107516

SponsorCentre for Infectious Disease Research in Zambia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Cholera Vaccination Reaction trials