Testing a new cholera vaccine in healthy volunteers

PanChol-100: Safety and Immunogenicity of PanChol: First-in-Human Study of a Novel Live Attenuated Oral Cholera Vaccine

This study is testing a new cholera vaccine called PanChol in healthy adults to see if it is safe and how well it helps their immune system fight cholera.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05657782 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of a new cholera vaccine called PanChol in healthy adults. The study consists of three modules: a fixed dose-ranging module, an adaptive dose-finding module, and a placebo-controlled expansion module. Participants will receive a single dose of PanChol and will be monitored for safety and immune response through blood and stool samples over several months. The trial aims to assess both the reactogenicity of the vaccine and its ability to generate an immune response against cholera.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 who meet specific health criteria.

Not a fit: Patients with underlying health conditions or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide effective protection against cholera, potentially reducing the incidence of this disease.

How similar studies have performed: Previous studies of cholera vaccines have shown promise, indicating that this approach may be viable.

Eligibility criteria

Inclusion Criteria:

1. Healthy adults aged from 18 to 55 years old.
2. Considered healthy, as judged by the clinical investigator, according to medical history, physical examination, vital signs, screening laboratories, and medication history.
3. Understanding and agreeing to comply with the study protocol including the inpatient period.
4. 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 postmenopausal (defined as as amenorrhea for at least 12 consecutive months before screening without an alternative medical cause)
   2. 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 IP.

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:

Each participant must not meet any of the following exclusion criteria to be eligible for enrollment in the study:

1. Confirmed or suspected immunosuppressive condition, as a result of a disease (e.g., primary immune deficiency, malignancy, HIV 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 live vaccine 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 will not be enrolled into this trial. This study involves more than minimal risk and no prospect of direct benefit for participants. Additionally, a subject who did not speak English may not be able to easily communicate safety concerns in a timely fashion to the study investigators
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 hypersensitivity 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.

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital Vaccine Unit — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Lindsey Baden, MD

Conditions: Cholera, Cholera Vaccine Toxicity, cholera, vaccine, safety, immunogenicity