Trial Summary
What is the purpose of this trial?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.
What data supports the idea that PanChol Vaccine for Cholera is an effective treatment?The available research shows that the oral cholera vaccine, Shanchol, which is similar to PanChol, provides significant protection against cholera. In a study conducted in India, Shanchol was found to offer 65% protection over five years against cholera. Another study highlighted that this vaccine can provide protection for at least three years without side effects. These findings suggest that PanChol Vaccine for Cholera is likely effective in preventing the disease.167912
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you've used systemic immunosuppressive therapy within 6 months, systemic antibiotics within 1 month, or certain vaccines recently. It's best to discuss your specific medications with the trial team.
Is the PanChol Vaccine a promising treatment for cholera?Yes, the PanChol Vaccine is a promising treatment for cholera. Similar vaccines like Shanchol have shown to provide significant protection against cholera, with effectiveness lasting up to five years. These vaccines are especially useful in areas where cholera is common, helping to prevent outbreaks and protect communities.45678
What safety data exists for the PanChol Vaccine for Cholera?The provided research does not contain specific safety data for the PanChol Vaccine for Cholera. The studies focus on adverse events related to other vaccines, such as rotavirus and smallpox vaccines, and general adverse event reporting in specific regions. Therefore, no direct safety data for the PanChol Vaccine is available in the given research.23101113
Eligibility Criteria
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.Treatment Details
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.
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).
PanChol is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as PanChol for:
- Prevention of cholera
🇺🇸 Approved in United States as PanChol for:
- Prevention of cholera
Find a clinic near you
Research locations nearbySelect from list below to view details:
Brigham and Women's Hospital Vaccine UnitBoston, MA
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
References
Development of oral vaccines against cholera and enterotoxinogenic Escherichia coli diarrhea. [2006]An oral cholera vaccine consisting of the immunogenic but completely nontoxic B subunit of cholera toxin in combination with heat- and formalin-killed cholera vibrios has been developed. This vaccine, which was designed to evoke antitoxic as well as antibacterial intestinal immunity, has in extensive clinical trials including a large field trial been shown to confer, without any side-effects, protection against cholera lasting for at least 3 years. The vaccine also induced protection of shorter duration against diarrhea caused by enterotoxinogenic Escherichia coli (ETEC). Significant progress has also been made recently using recombinant DNA techniques towards development of a live attenuated oral cholera vaccine. Furthermore, new knowledge about virulence factors and protective antigens of ETEC has given promise that an effective oral ETEC vaccine may soon be developed combining a B subunit toxoid with inactivated ETEC expressing the most important colonization fimbrial antigens.
Smallpox vaccine adverse events among civilians--United States, March 4-10, 2003. [2008]During the civilian smallpox vaccination program, CDC, the Food and Drug Administration, and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (Table). Nonserious events are reported through passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of March 7, 2003, and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of March 10.
Assessment of postlicensure safety of rotavirus vaccines, with emphasis on intussusception. [2009]The global implementation of rotavirus vaccines will result in a major step toward limiting the disease burden of rotavirus infection. However, as history has shown with the experience of Rotashield (Wyeth Lederle Vaccines), the introduction of a new vaccine should occur in parallel with a postmarketing surveillance strategy to detect any unexpected or rare adverse events. Two new rotavirus vaccines (Rotarix [GSK Biologicals] and RotaTeq [Merck]) have been found to be safe and effective in large clinical trials involving >60,000 infants in the Americas and Europe. However, given that intussusception is an extremely rare event, some risk could be detected as the vaccine is administered to a larger number of infants. In response to a recommendation of the World Health Organization Global Advisory Committee for Vaccine Safety, a standardized approach to the postmarketing surveillance of rotavirus vaccine safety has been developed. We review the principal safety issues requiring further evaluation in postlicensure use of rotavirus vaccines. For intussusception, we also discuss challenges and approaches to monitoring.
Vaccination strategies to combat an infectious globe: oral cholera vaccines. [2021]Cholera is a substantial health burden in many countries in Africa and Asia, where it is endemic. It is as well responsible for ongoing epidemics in sub-Saharan Africa which are becoming greater in terms of frequency, extension, and duration. Given the availability of two oral cholera vaccines and the new data on their efficacy, field effectiveness, feasibility, and acceptance in cholera-affected populations and in travelers, these vaccines should be used in endemic areas, in travelers for these areas and should be considered in areas at risk for outbreaks. The two vaccines currently available in worldwide are: (1) The killed oral vaccine (Dukoral, licensed by SBL-Sweden to Crucell-Holland) is recommended since 1999 by WHO and consists of a mixture of four preparations of heat or formalin killed whole cell Vibrio cholera O1 (Inaba and Ogaba serotypes, and classical and El Tor biotypes) that are then added with purified recombinant cholera toxin (CT) B subunit. Because CT cross-reacts with Escherichia coli LT the vaccine also provides short-term protection against ETEC (enterotoxigenic E. coli) which is of added benefit for travelers. It is available in more than 60 countries. (2) A bivalent O1 and O139 whole cell oral vaccine without CT B subunit (Shanchol) has been lately developed in Vietnam (licensed by VaBiotech-Viet Nam to Shantha Biotechnics-India. It is available in India and Indonesia. A structured search of papers in PubMed and reports on cholera vaccines by WHO and CDC, as well as critical reading and synthesis of the information was accomplished. Inclusion criteria were defined according to reports quality and relevance.
Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age. [2022]Safety and immunogenicity study of an oral, killed, bivalent whole-cell, cholera vaccine, Shanchol was carried out in Bangladeshi participants. This study was conducted prior to initiating a feasibility study in Bangladesh.
Use of Vibrio cholerae vaccine in an outbreak in Guinea. [2022]The use of vaccines to prevent and control cholera is currently under debate. Shanchol is one of the two oral cholera vaccines prequalified by the World Health Organization; however, its effectiveness under field conditions and the protection it confers in the first months after administration remain unknown. The main objective of this study was to estimate the short-term effectiveness of two doses of Shanchol used as a part of the integrated response to a cholera outbreak in Africa.
Effectiveness of an oral cholera vaccine campaign to prevent clinically-significant cholera in Odisha State, India. [2022]A clinical trial conducted in India suggests that the oral cholera vaccine, Shanchol, provides 65% protection over five years against clinically-significant cholera. Although the vaccine is efficacious when tested in an experimental setting, policymakers are more likely to use this vaccine after receiving evidence demonstrating protection when delivered to communities using local health department staff, cold chain equipment, and logistics.
The oral cholera vaccine Shanchol™ when stored at elevated temperatures maintains the safety and immunogenicity profile in Bangladeshi participants. [2022]The oral cholera vaccine (OCV), Shanchol™ has shown protective efficacy lasting up to 5 years, however, requirement for a cold chain limits its use in resource poor settings. The study was conducted to determine the safety and immunogenicity of Shanchol in adult participants in Bangladesh when stored at elevated temperatures.
Antibody Secreting Cell Responses following Vaccination with Bivalent Oral Cholera Vaccine among Haitian Adults. [2021]The bivalent whole-cell (BivWC) oral cholera vaccine (Shanchol) is effective in preventing cholera. However, evaluations of immune responses following vaccination with BivWC have been limited. To determine whether BivWC induces significant mucosal immune responses, we measured V. cholerae O1 antigen-specific antibody secreting cell (ASC) responses following vaccination.
Analysis of adverse events following immunization in Minas Gerais, Brazil, 2011: a cross-sectional study. [2022]to analyze the main adverse events occurring following immunization in Minas Gerais State, Brazil, in 2011.
Background rates of disease in Latin American children from a rotavirus vaccine study. [2018]Knowledge of background rates of adverse events is crucial to assess vaccine safety concerns. We used data from a rotavirus vaccine study (Ruiz-Palacios et al., NEJM, 2006) including 63,225 infants from 11 Latin American countries to investigate reporting rates of serious adverse events (SAEs) among these infants, and describe rates by country, gender, age, and season.
Comparison of the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children: an open-label, randomised, multicentre, non-inferiority, parallel-group, phase 3 trial. [2023]Considering the cholera menace in India and to seek licensure of the oral cholera vaccine (OCV), Euvichol-Plus, we conducted a clinical trial to compare the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children.
Adverse event following immunization or vaccination in children in Minas Gerais: 2015 to 2020. [2023]To describe adverse event following immunization or vaccination in children in Minas Gerais: 2015 to 2020, resulting from immunization errors in children from zero to nine years old.