RECRUITING

First in Human Phase 1 Ascending Dose Study of PanChol in Healthy Volunteers

Conditions

Cholera Cholera Vaccine Toxicity vaccine safety immunogenicity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a first-in-human, Phase 1 study of the safety, tolerability, and immunogenicity of PanChol in healthy volunteers. There will be three modules in this clinical trial assessing dosing, safety, and immunogenicity: 1. a fixed dose-ranging module, 2. an adaptive dose-finding/optimization module, and 3. a placebo-controlled expansion module.

Official Title

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

Quick Facts

Study Start:2022-12-12

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05657782

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Lindsey Baden, MD

CONTACT

617-525-8418

lbaden@bwh.harvard.edu

Study Locations (Sites)

Brigham and Women's Hospital Vaccine Unit

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-12

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2022-12-12

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

cholera
vaccine
safety
immunogenicity

Additional Relevant MeSH Terms

Cholera
Cholera Vaccine Toxicity