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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 180 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination.
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.
Secondary outcome measures
The magnitude of pre- and post-vaccination serum vibriocidal titers to both Inaba and Ogawa V. cholerae.
The stool shedding of PanChol organisms using stool cultures.
Other outcome measures
The changes of antibodies targeting cholera specific polysaccharides.
The changes of antibody secreting cell response.
The stool microbiota modification according to 16S rRNA sequencing and/or metagenomics.
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
1,615 Previous Clinical Trials
11,470,777 Total Patients Enrolled
1 Trials studying Cholera
2,207 Patients Enrolled for Cholera
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals aged 45 and older participate in this research?
"This research is open to individuals who are 18 years and above, but not surpassing the age of 55."
Answered by AI
Does this clinical trial have any vacancies open?
"The clinical trial is currently seeking participants, with the initial posting having been made on December 12th 2022 and updated most recently in November of 2020."
Answered by AI
Has the Fixed Dose-Ranging protocol been given regulatory approval?
"As this is a phase 1 trial with limited evidence of safety and efficacy, our team at Power has assigned Fixed Dose-Ranging a score of 1 on the scale from 1 to 3."
Answered by AI
How many participants are being admitted to this research endeavor?
"Indeed, current records on clinicaltrials.gov indicate that recruitment for this trial is in full swing. It was initially posted on December 12th 2022 and recently revised on the 11th of December. 53 patients are sought from 1 site location."
Answered by AI
To whom is this medical experiment open for enrollment?
"This trial is searching for 53 people who have contracted cholera, aged between 18 and 55. To be eligible to participate, the following criteria must be met: Healthy adults in their late teens or early fifties; no medical history that would disqualify them as healthy; a clear understanding of what's expected from them throughout the study period; female participants need to either be surgically sterile/postmenopausal OR use an acceptable form of contraception for at least 28 days before administration until 3 months after receiving IP.; Acceptable methods include barrier methods (condom etc.), intrauterine device, hormonal birth control taken orally/intrav"
Answered by AI
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