Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

NCT03251495 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00097012R01AI137127
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholera

Keywords

Vaccination; Contagious Diseases; Tropical Medicine; Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• Level of Antibody Titers in Serum

  Antibody response is evaluated as the level of antibody titers in serum. Higher vibriocidal antibody titers indicate greater protection against cholera.

  Day 1 (pre-vaccination), Day 29

Secondary Outcomes (7)

• Plasmablast Levels

  Day 1 (pre-vaccination), Day 8, Day 29

• Activated B Cell Levels

  Day 1 (pre-vaccination), Day 8, Day 29

• Memory B Cell Levels

  Day 1 (pre-vaccination), Day 29

• Number of Monoclonal Antibodies Produced Per Participant

  Day 8

• Number of Cholera Toxin B (CTB) Specific Monoclonals and Lipopolysaccharide (LPS) Specific Monoclonal Antibodies Per Participant

  Day 8

Study Arms (1)

Vaxchora Vaccination

EXPERIMENTAL

Healthy participants will receive a single dose of oral live cholera vaccine.

Drug: Vaxchora

Interventions

Vaxchora DRUG

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.

Vaxchora Vaccination

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Traveled 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Hope Clinic of Emory University

Atlanta, Georgia, 30030, United States

Location

Related Publications (1)

• Adekunle O, Dretler A, Kauffman RC, Cho A, Rouphael N, Wrammert J. Longitudinal analysis of human humoral responses after vaccination with a live attenuated V. cholerae vaccine. PLoS Negl Trop Dis. 2021 Sep 3;15(9):e0009743. doi: 10.1371/journal.pntd.0009743. eCollection 2021 Sep.

  PMID: 34478460 DERIVED

MeSH Terms

Conditions

Cholera; Communicable Diseases

Interventions

Vaxchora

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nadine Rouphael, MD
• Organization: Emory University

nroupha@emory.edu

404-712-1370

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: August 29, 2017
• Primary Completion: December 10, 2024
• Study Completion: November 6, 2025
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)