NCT01585181

Brief Summary

The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

April 23, 2012

Last Update Submit

June 26, 2023

Conditions

Cholera

Keywords

Vaccine, Bacterial disease condition, Cholera

Outcome Measures

Primary Outcomes (2)

  • Safety

    Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs

    Day 0-180

  • Immunogenicity

    Immunogenicity as defined as rate of seroconversion (4-fold rise) of serum Inaba vibriocidal antibody and initial estimates of between subject variability of vibriocidal antibody response

    Day 0-28

Secondary Outcomes (4)

  • Kinetics

    Day 0-28

  • Serum anti-cholera toxin (CT) IgG antibody conversion rates

    Day 0-28

  • Fecal shedding

    Day 0-7

  • Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts

    Day 0-28

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Biological: Placebo

PXVX0200

EXPERIMENTAL
Biological: PXVX0200

Interventions

PXVX0200BIOLOGICAL

Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension

PXVX0200
PlaceboBIOLOGICAL

Approx 2 grams of lactose reconstituted in water

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Men or women, age 18 to 50 years (inclusive) without significant medical history, physical or clinical lab abnormalities (as per protocol defined ranges)
  • Women of childbearing potential must have negative urine pregnancy test and must be willing to use adequate birth control for 2 months following vaccination and have additional pregnancy tests as indicated
  • Vaccinees must live alone or have no more than two household contacts willing to sign informed consent and participate in the study
  • Household contacts must be healthy (based on medical history) men or women aged 18-65 years (inclusive)

You may not qualify if:

  • Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have unstable medical condition or are under the age of 18
  • Childcare workers who have direct contact with children who are 2 years of age or younger or those employed in the food service industry
  • Resides with HHCs who are under the age of 18 or over the age of 65
  • Has abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months
  • Has known allergy to, or known medical condition that precludes the use of both tetracycline or ciprofloxacin
  • Previously received a licensed or investigational cholera vaccine
  • Has history of cholera or enterotoxigenic E. coli infection (natural infection or experimental challenge)
  • Travel to a cholera-endemic area and experienced symptoms consistent with traveler's diarrhea in the previous 5 years
  • Received or plans to receive any other licensed vaccines from 14 days prior to the study vaccination until Day 28
  • Received or plans to receive antibiotics (other than protocol-specified) or chloroquine within 14 days prior to the study vaccination through to Day 28

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • Chen WH, Greenberg RN, Pasetti MF, Livio S, Lock M, Gurwith M, Levine MM. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR, prepared from new master and working cell banks. Clin Vaccine Immunol. 2014 Jan;21(1):66-73. doi: 10.1128/CVI.00601-13. Epub 2013 Oct 30.

    PMID: 24173028DERIVED

Related Links

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2012

Study Completion

January 1, 2013

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations

US(2)