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Virus Therapy
PanChol Vaccine for Cholera
Phase 1
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial tests a new vaccine's safety, tolerability, and efficacy in healthy volunteers. It involves 3 stages of tests.
Who is the study for?
Healthy adults aged 18-55 can join this trial. They must be in good health based on medical checks, agree to stay in the hospital when needed, and use reliable contraception or abstain from sex if they can have children. People with immune issues, recent GI illness, previous cholera vaccine or infection, abnormal stool patterns, allergies to PanChol/placebo ingredients, recent antibiotic use or vaccines cannot join.
What is being tested?
The study is testing a new cholera vaccine called PanChol. It's done in three parts: figuring out the right dose range; finding the best dose; and comparing it with a placebo (a treatment with no active drug). Volunteers will get either PanChol or placebo to check for safety and how well their bodies respond.
What are the potential side effects?
Since this is a first-in-human study of PanChol, side effects are not fully known yet but may include typical vaccine reactions like soreness at injection site, fever, fatigue or allergic reactions. The trial aims to identify any potential side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Fixed Dose-RangingExperimental Treatment1 Intervention
The first, fixed dose-ranging module utilizes a classical "3+3 design". The name is derived from the typical cohort size at a given dose \[3\], and the typical expansion size at that dose \[3\] if 1 dose-limiting side effect is observed. This module will address the uncertainty regarding the relationship between dose and adverse events (AEs). A set of pre-specified doses (log10 values 6, 7, 8, 9, and 10) will be employed, based on animal experiments and other live OCV trials. Three participants will be administered each dose (15 participants total).
Group II: Adaptive Dose-finding/OptimizationExperimental Treatment1 Intervention
A modified continual reassessment method (CRM) adaptive design will guide the dose optimization module. CRM cohorts comprise 3 participants treated concurrently at each dose. All three subjects in each cohort will receive a single dose based on the CRM model fit to all the available dose-response data.
Group III: Expansion module - active productActive Control1 Intervention
The purpose of the expansion cohort is to gather additional clinical experience at the optimal dose of PanChol and increase the precision with which the rate of AEs is estimated. The expansion module will be randomized, double blind and placebo-controlled (20 receiving active product, 6 receiving placebo, 26 participants total).
Group IV: Expansion module - placeboPlacebo Group1 Intervention
The purpose of the expansion cohort is to gather additional clinical experience at the optimal dose of PanChol and increase the precision with which the rate of AEs is estimated. The expansion module will be randomized, double blind and placebo-controlled (20 receiving active product, 6 receiving placebo, 26 participants total).
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,840,182 Total Patients Enrolled
1 Trials studying Cholera
2,207 Patients Enrolled for Cholera
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a fever or stomach illness in the last week.I haven't taken any antibiotics in the last month.I regularly use laxatives.I speak English.I have a GI condition that could affect my treatment.I am allergic to PanChol or its ingredients like sodium bicarbonate, lactose, ascorbic acid.I have been vaccinated against cholera.I have not received a live vaccine in the last 4 weeks and do not plan to get one in the next 4 weeks.I work directly with children under 2 years old.I have had diarrhea in the last 48 hours.I have had cholera before.I have less than 3 or more than 21 bowel movements a week.I have a condition or have taken medication that weakens my immune system.I am between 18 and 55 years old and healthy.I have received or plan to receive a non-live vaccine within 4 weeks around enrollment.I am considered healthy based on my recent medical exams and history.I don't have any health conditions that would make vaccines unsafe for me.I am not pregnant or breastfeeding, and if of childbearing age, I am using effective birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion module - placebo
- Group 2: Fixed Dose-Ranging
- Group 3: Adaptive Dose-finding/Optimization
- Group 4: Expansion module - active product
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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