ClinicalTrials.gg
RecruitingNCT07107516PanCholUpdated Oct 6, 2026

Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers

A Phase 1 interventional study of PanChol in Cholera Vaccination Reaction, sponsored by Centre for Infectious Disease Research in Zambia. Recruiting at 1 site in Zambia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Centre for Infectious Disease Research in Zambia · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Oct 6, 2026Primary completion movedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Cholera Vaccination Reaction

Browse trials for

Keywords

  • cholera
  • vaccine
  • safety
03

In context

Cholera

83 studies on the registry are indexed under Cholera; 16 are open to participants now.

This study's planned enrollment of 32 is below the median of 262 across 72 interventional studies indexed under Cholera.

Browse Cholera studies →

Lead sponsor

Centre for Infectious Disease Research in Zambia is the lead sponsor of 41 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Must have given written (signed and dated) and any other authorizations required by local law and be able to comply with all study requirements.
  2. Healthy adults aged from 18 to 55 years old.
  3. Considered healthy, as judged by the clinical investigator, according to medical history, physical examination, vital signs, screening laboratories, and medication history.
  4. Capable of understanding, consenting, and complying with the entire study protocol including the inpatient period.
  5. Female participants must be non-pregnant and non-lactating and either

    1. surgically sterile (history of bilateral ligation, bilateral salpingectomy, bilateral oophorectomy, total hysterectomy) or (defined as amenorrhea for at least 12 consecutive months before screening without an alternative medical cause)
    2. be of and practicing an acceptable method of or abstaining from all activities that could result in pregnancy for at least 28 days before vaccination until 3 months after receiving the product.

Acceptable methods of contraception include barrier methods (such as condom, diaphragm, or cervical cap used in conjunction with spermicide), intrauterine device, hormonal contraception (that may be taken or administered by oral, intravaginal, transdermal, subdermal or IM route), vasectomized partner (the vasectomized partner should be the sole partner for that participant)

Exclusion criteria

Exclusion Criteria:

  1. Confirmed or suspected condition, as a result of a disease (e.g., primary immune deficiency, , infection) or have taken any systemic immunosuppressive therapy within 6 months of enrollment.
  2. Pregnant or lactating women.
  3. History of gastrointestinal (GI) disorder, such as previous major GI surgery, malabsorption, or any chronic GI disorders that would interfere, according to the investigator, with the IP.
  4. Acute GI or febrile illness within 7 days of enrollment.
  5. Have any acute or chronic medical condition that, in the opinion of the investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
  6. History of cholera vaccination.
  7. History of cholera infection.
  8. Abnormal stool pattern, defined as \< 3 or >21 stools per week.
  9. Allergy or intolerance to PanChol or placebo component (sodium bicarbonate, lactose, ascorbic acid)
  10. Use of any systemic antibiotics within 1 month of PanChol administration.
  11. Receipt of a in the previous 4 weeks or planned in the 4 weeks following enrollment.
  12. Receipt of a killed or subunit (non-live) vaccine in the previous 2 weeks or planned in the 2 weeks following enrollment.
  13. Individuals who do not speak English
  14. Childcare workers with direct contact with children ≤ 2 years of age
  15. Individuals whose occupation involves handling of food
  16. Healthcare workers who have direct contact with patients who are immunodeficient, HIV-positive, or have an unstable medical condition
  17. Use laxatives regularly
  18. Have diarrhea within 48 hours before enrollment
  19. Have a history of to any of the tetracyclines
  20. Have a history of hypersensitivity to streptomycin or any aminoglycoside due to the known cross-sensitivity of patients to drugs in this class.
  21. Individuals who have a household member who are immunodeficient, HIV-positive, or have an unstable medical condition.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    cohort 2a

    The PanChol vaccine will be given at a dose of 2 x 10\^7 CFU in this arm

    Biological: PanChol

  • Experimental
    cohort 2b

    The PanChol vaccine will be given at a dose of 2 x 10\^8 CFU in this arm

    Biological: PanChol

  • No intervention
    cohort 2c

Interventions

  • BiologicalPanChol

    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.

06

What researchers measure

Primary outcomes

  1. vaccine safety

    The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination

    Time frame: 14 days after vaccination

Secondary outcomes

  1. immunogenicity

    The seroconversion (4-fold rise titer over baseline) of the vibriocidal titers to both Inaba and Ogawa V. cholerae between pre- and post-vaccination with PanChol.

    Time frame: 180 days after vaccination

  2. vaccine stool shedding

    Stool shedding of PanChol organisms using quantitative and qualitative stool cultures

    Time frame: 8 days after vaccination

Other outcomes

  1. exploratory- serum antibody changes

    Changes of IgG, IgA, and IgM antibodies targeting Inaba- and Ogawa-specific polysaccharides, CT-B and TCP.

    Time frame: 180 days after vaccination

  2. exploratory- IgA and IgG secreting cell responses

    Changes of IgA- and IgG-antibody secreting cell responses (ALS/plasmablast responses) and the memory B cell (MBC) response.

    Time frame: 180 days after vaccination

  3. Exploratory- Microbiome modification

    Stool microbiota modification according to 16S rRNA sequencing and/or metagenomic sequencing

    Time frame: 180 days after vaccination

07

Study locations

1 of 1 sites recruiting
  • CIDRZ Matero clinical reseach site
    Lusaka, Lusaka Province 10101, Zambia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 31, 2026→Nov 30, 2026
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Primary completion Aug 31, 2026→Nov 30, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07107516
Lead sponsor
Centre for Infectious Disease Research in Zambia
Responsible party
Sponsor
First posted
Aug 6, 2025
Start date
May 20, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Oct 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion