NCT01895855

Brief Summary

The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

July 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

April 1, 2021

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

July 5, 2013

Results QC Date

July 5, 2018

Last Update Submit

June 26, 2023

Conditions

Cholera

Outcome Measures

Primary Outcomes (2)

  • % of Participants With Moderate to Severe Diarrhea

    Determine whether a single dose of PXVX0200 provides significantly greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) diarrhea.

    Ten days after vaccination

  • % of Participants With Moderate to Severe Diarrhea

    Determine whether a single dose of PXVX0200 provides significant greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 3 months after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) of diarrhea.

    Ninety days after vaccination

Secondary Outcomes (11)

  • Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge

    Through 10 Days following challenge

  • Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge

    Through 10 Days following challenge

  • % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge

    Through 10 Days following challenge

  • % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge

    Through 10 Days following challenge

  • % of Participants With Fever Following the 10 Day Cholera Challenge

    Through 10 Days following challenge

  • +6 more secondary outcomes

Study Arms (2)

PXVX0200

EXPERIMENTAL

Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU

Biological: PXVX0200

Placebo

PLACEBO COMPARATOR

Biological: Placebo physiological saline

Biological: placebo

Interventions

PXVX0200BIOLOGICAL

Single dose; liquid suspension after reconstitution with buffer; 5x10\^8

PXVX0200
placeboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men or women,
  • age 18 to 45 years inclusive;
  • normal medical history and physical examination; and
  • no clinically significant abnormalities from:
  • urine dipstick for glucose, protein, and blood
  • complete blood count,
  • serum hepatic transaminases,
  • total bilirubin (direct if abnormal),
  • creatinine,
  • electrolytes,
  • albumin, or
  • electrocardiogram.
  • Women must have a negative pregnancy test.

You may not qualify if:

  • travel to a cholera endemic area in the previous 5 years;
  • abnormal stool pattern or regular use of laxatives;
  • history of eating disorders (such as bulimia), anal or rectal disorders, allergy to tetracycline and/or ciprofloxacin;
  • history of cholera or enterotoxigenic E. coli challenge or infection;
  • current or recent antibiotic use;
  • pregnancy or nursing;
  • positive serology for HIV, hepatitis B antigen, or hepatitis C;
  • any immunosuppressive medical condition;
  • history of hospitalization for psychiatric illness or use of specific psychiatric drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Cincinnati Children'S Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (5)

  • Chen WH, Cohen MB, Kirkpatrick BD, Brady RC, Galloway D, Gurwith M, Hall RH, Kessler RA, Lock M, Haney D, Lyon CE, Pasetti MF, Simon JK, Szabo F, Tennant S, Levine MM. Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection With Vibrio cholerae O1 El Tor. Clin Infect Dis. 2016 Jun 1;62(11):1329-1335. doi: 10.1093/cid/ciw145. Epub 2016 Mar 21.

    PMID: 27001804RESULT

  • Haney DJ, Lock MD, Gurwith M, Simon JK, Ishioka G, Cohen MB, Kirkpatrick BD, Lyon CE, Chen WH, Sztein MB, Levine MM, Harris JB. Lipopolysaccharide-specific memory B cell responses to an attenuated live cholera vaccine are associated with protection against Vibrio cholerae infection. Vaccine. 2018 May 11;36(20):2768-2773. doi: 10.1016/j.vaccine.2018.04.011. Epub 2018 Apr 11.

    PMID: 29655627RESULT

  • Haney DJ, Lock MD, Simon JK, Harris J, Gurwith M. Antibody-Based Correlates of Protection Against Cholera Analysis of a Challenge Study in a Cholera-Naive Population. Clin Vaccine Immunol. 2017 May 31;24(8):e00098-17. doi: 10.1128/CVI.00098-17. Online ahead of print.

    PMID: 28566334RESULT

  • Hossain M, Islam K, Kelly M, Mayo Smith LM, Charles RC, Weil AA, Bhuiyan TR, Kovac P, Xu P, Calderwood SB, Simon JK, Chen WH, Lock M, Lyon CE, Kirkpatrick BD, Cohen M, Levine MM, Gurwith M, Leung DT, Azman AS, Harris JB, Qadri F, Ryan ET. Immune responses to O-specific polysaccharide (OSP) in North American adults infected with Vibrio cholerae O1 Inaba. PLoS Negl Trop Dis. 2019 Nov 19;13(11):e0007874. doi: 10.1371/journal.pntd.0007874. eCollection 2019 Nov.

    PMID: 31743334DERIVED

  • Islam K, Hossain M, Kelly M, Mayo Smith LM, Charles RC, Bhuiyan TR, Kovac P, Xu P, LaRocque RC, Calderwood SB, Simon JK, Chen WH, Haney D, Lock M, Lyon CE, Kirkpatrick BD, Cohen M, Levine MM, Gurwith M, Harris JB, Qadri F, Ryan ET. Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers. PLoS Negl Trop Dis. 2018 Apr 6;12(4):e0006376. doi: 10.1371/journal.pntd.0006376. eCollection 2018 Apr.

    PMID: 29624592DERIVED

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
David Cassie, Scientist, Clinical Research
Organization
Emergent BioSolutions Canada Inc.
dcassie@ebsi.com
204-275-4589

Study Officials

  • James McCarty, MD

    Emergent BioSolutions

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 11, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

June 28, 2023

Results First Posted

April 1, 2021

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)