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Trial record 1 of 25 for:    vaxchora | Phase 2, 3
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Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03251495
Recruitment Status : Suspended (Recruitment and enrollment currently suspended due to COVID-19.)
First Posted : August 16, 2017
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Nadine Rouphael, Emory University

Brief Summary:

The primary objective of this study is to evaluate the antibody response to the cholera vaccine, Vaxchora®, in healthy subjects.

Investigators also seek to evaluate additional markers of the adaptive immune response including plasmablasts, activated B cells, memory B cells, and T cell responses in healthy subjects receiving cholera vaccine, produce monoclonal antibodies against cholera, and evaluate the safety and reactogenicity in healthy subjects receiving cholera vaccine.


Condition or disease Intervention/treatment Phase
Cholera Drug: Vaxchora Phase 2

Detailed Description:

Cholera is a life-threatening illness that causes diarrhea. Cholera is caused by eating or drinking the Vibrio cholera bacteria. Each year, there are about 1.3 to 4.0 million cases of cholera worldwide, resulting in 21,000 to 143,000 deaths. The bacteria is spread through water or food that has stool in it. Up to 50 countries with limited access to clean water are more likely to have outbreaks. In the United States most cases are linked to travel to these countries; however, there are 10-15 cases acquired in the United States each year because of undercooked seafood. Cholera spreads very easily. Illness from Cholera can vary from no symptoms to severe watery diarrhea that can cause death by dehydration in a healthy person within hours.

Vaxchora is a live attenuated cholera vaccine that protects against some cholera strains. It has been approved by the FDA since June 2016. Since October, 2016, this vaccine has been recommended for certain travelers 18 through 64 years of age going to cholera-affected areas. The purpose of this study is to look at the immune responses to the FDA approved cholera vaccine (Vaxchora®).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunologic Responses to a Live Attenuated Oral Cholera Vaccine
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera

Arm Intervention/treatment
Experimental: Vaxchora Vaccination
Healthy subjects will receive a single dose of oral live cholera vaccine.
Drug: Vaxchora
Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants will receive one single oral dose of 100 mL.




Primary Outcome Measures :
  1. Percentage of Positive Responders [ Time Frame: Day 29 ]
    Antibody titers will be collected to assess the level of immune response to vaccination. A positive responder is defined as a participant with a titer above 40 at day 29, or that shows a four-fold increase over baseline.


Secondary Outcome Measures :
  1. Plasmablast Levels [ Time Frame: Day 29 ]
    Plasmablasts will be collected via blood draw and isolated and assessed for counts by the study team. A positive response is defined as a four-fold increase over the baseline measure.

  2. Activated B Cell Levels [ Time Frame: Day 29 ]
    Activated B cells will be collected via blood draw and isolated and assessed for counts by the study team. A positive response is defined as a four-fold increase over the baseline measure.

  3. Memory B-Cell Levels [ Time Frame: Day 29 ]
    Memory B-cells will be collected via blood draw and isolated and assessed for counts by the study team. A positive response is defined as a four-fold increase over the baseline measure.

  4. Memory T-Cell Levels [ Time Frame: Day 29 ]
    T-cells will be collected via blood draw and isolated and assessed for counts by the study team. A positive response is defined as a four-fold increase over the baseline measure.

  5. Number of Samples from which Monoclonal Antibodies Produced [ Time Frame: Day 29 ]
    The ability to isolate monoclonal antibodies will be assessed by study lab personnel.

  6. Number of Adverse Events [ Time Frame: Duration of Study (Up to 29 Days) ]
    The number of solicited and unsolicited adverse events will be collected.

  7. Number of Serious Adverse Events [ Time Frame: Duration of Study (Up to 29 Days) ]
    The number of serious adverse events will be collected.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Capable of informed consent and provision of written informed consent before any study procedures
  • Capable of attending all study visits according to the study schedule
  • Are in good health, as determined by medical history and targeted physical exam related to this history
  • Female subjects of childbearing* age must have a negative urine pregnancy test before study vaccination, and must use two forms of contraception** to avoid pregnancy within one month of Vaxchora administration.

Exclusion Criteria:

  • Have an acute illness within 72 hours before vaccination
  • Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination
  • Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination
  • Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination
  • Reside with individuals under the age of 2 or with an immunocompromised individuals
  • Have a known history of autoimmune disease
  • Have a history of Guillain-Barre Syndrome
  • Have plans to receive any vaccine from 28 days prior to study vaccination until Day 29
  • Has previously received a cholera vaccine or have a known history of V. Cholerae.
  • Have donated blood or blood products within 56 days before study vaccination, plan to donate blood at any time during the 56-day duration of subject study participation, or plan to donate blood within 56 days after the last blood draw
  • Have known hypersensitivity or allergy to any component of the vaccine or history of anaphylaxis with a vaccine or vaccine component
  • Have allergy to tetracycline and/or ciprofloxacin
  • Are pregnant or breastfeeding or plan to within one month of vaccination
  • Travelled to a cholera endemic area and had traveler's diarrhea in the previous 5 years
  • Have abnormal stool pattern (fewer than 3 stools/ week or greater than 2 stools/ day) or regular use of laxatives in the last 6 months
  • Have current or recent antibiotic use in the past 14 days
  • Are healthcare workers who have direct contact with patients who are immunocompromised, have unstable medical conditions, or are under the age of 2
  • Are childcare caregivers who have direct contact with children who are 2 years or younger.
  • Are employed in the food industry
  • Have received any vaccine within the previous 21 days
  • History of bleeding disorders or current use of warfarin, aspirin, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) or other blood thinner/ anticoagulant medications in the past week for subjects undergoing intestinal biopsies.
  • Use of benzodiazepines or narcotics for subjects undergoing intestinal biopsies 4 weeks prior to the procedure
  • Any contraindications to endoscopy/concerns of the anesthesiologist for subjects who agree for EGD/biopsies.
  • BMI > 35 kg/m2
  • Have a diagnosis of any small bowel disease. This includes but is not limited to inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, indeterminate colitis, or microscopic colitis), small bowel obstruction, celiac disease, h/o small bowel resection, small bowel lymphoma, Whipple's disease, primary Intestinal lymphangiectasis, abdominal radiation.
  • Current medications for the treatment of Gastroesophageal reflux disease (GERD) or dyspepsia
  • History of Helicobacter pylori (H. pylori) infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251495


Locations
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United States, Georgia
The Hope Clinic of Emory University
Atlanta, Georgia, United States, 30030
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Nadine Rouphael, MD Emory University
  Study Documents (Full-Text)

Documents provided by Nadine Rouphael, Emory University:
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Responsible Party: Nadine Rouphael, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03251495    
Other Study ID Numbers: IRB00097012
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nadine Rouphael, Emory University:
Vaccination
Contagious Diseases
Tropical Medicine
Infectious Diseases
Additional relevant MeSH terms:
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Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections