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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Dec 11, 2022

Keywords

ClinConnect Summary

This clinical trial, called a Phase 1 study, is testing a new vaccine called PanChol in healthy adults to see if it is safe and effective. The study is looking at how well the vaccine works to help protect against cholera, a serious infection that can cause severe diarrhea and dehydration. To find out how different doses of the vaccine perform, the trial will take place in three parts, where participants may receive either the vaccine or a placebo (a substance that looks like the vaccine but has no active ingredients).

To be eligible for this study, participants must be healthy adults between the ages of 18 and 55. They should not have any serious health conditions, recent infections, or a history of cholera vaccination or infection. Participants will be closely monitored while receiving the vaccine and will need to follow study guidelines, including staying in the hospital for a period after vaccination. This trial is currently looking for volunteers, and while participants may not receive any direct benefits from joining, they will contribute to important research on cholera prevention.

Gender

ALL

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.