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Trial record 1 of 1 for:    NCT01895855
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Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

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ClinicalTrials.gov Identifier: NCT01895855
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Tracking Information
First Submitted Date  ICMJE July 5, 2013
First Posted Date  ICMJE July 11, 2013
Results First Submitted Date  ICMJE July 5, 2018
Results First Posted Date  ICMJE April 1, 2021
Last Update Posted Date April 1, 2021
Study Start Date  ICMJE September 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • % of Participants With Moderate to Severe Diarrhea [ Time Frame: Ten days after vaccination ]
    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.
  • % of Participants With Moderate to Severe Diarrhea [ Time Frame: Ninety days after vaccination ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
  • Ten day cholera challenge [ Time Frame: Ten days after vaccination ]
    Determine whether a single dose of PXVX0200 provides significant protection against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination.
  • Ninety day cholera challenge [ Time Frame: Ninety days after vaccination ]
    Determine whether a single dose of PXVX0200 provides significant protection against a challenge with virulent V. cholerae O1 El Tor Inaba at 3 months after vaccination.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge [ Time Frame: Through 10 Days following challenge ]
    Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 10 day cholera challenge.
  • Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge [ Time Frame: Through 10 Days following challenge ]
    Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 90 day cholera challenge.
  • % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge [ Time Frame: Through 10 Days following challenge ]
    Incidence of mild or worse (any severity) diarrhea following the 10 day cholera challenge.
  • % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge [ Time Frame: Through 10 Days following challenge ]
    Incidence of mild or worse (any severity) diarrhea following the 90 day cholera challenge.
  • % of Participants With Fever Following the 10 Day Cholera Challenge [ Time Frame: Through 10 Days following challenge ]
    Incidence of mild or worse fever following the 10 day cholera challenge.
  • % of Participants With Fever Following the 90 Day Cholera Challenge [ Time Frame: Through 10 Days following challenge ]
    Incidence of mild or worse fever following the 90 day cholera challenge.
  • Number of Days With Fecal Shedding Following 10 Day Challenge [ Time Frame: Through 10 Days post challenge ]
    Number of days of fecal shedding of wild type V. cholerae following 10 Day Challenge.
  • Number of Days With Fecal Shedding Following 90 Day Challenge [ Time Frame: Through 10 days following challenge ]
    Number of days of fecal shedding of wild type V. cholerae following 90 Day Challenge
  • # of Days With Positive Stool Culture Following 10 Day Cholera Challenge [ Time Frame: Through 10 Days following challenge ]
    Total number of days with a positive stool culture following the 10 Day Cholera challenge.
  • # of Days With Positive Stool Culture Following 90 Day Cholera Challenge [ Time Frame: Through 10 Days following challenge ]
    Total number of days with a positive stool culture following 90 Day Cholera Challenge
  • % of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination [ Time Frame: Following vaccination (Days 1 - 8) and to Day 29 ]
    Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever following vaccination (through Day 8). Incidence and severity of unsolicited adverse events following vaccination (through Day 29).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
  • disease severity [ Time Frame: from vaccination through day 180 ]
    Total weight of diarrheal stools Incidence of diarrhea of any severity Incidence of fever Incidence of fecal shedding of wild type Vibrio cholerae Peak concentration of wild type Vibrio cholerae detected in stool
  • tolerability of vaccine [ Time Frame: following vaccination through 180 days ]
    Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever Incidence and severity of unsolicited adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Official Title  ICMJE A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination
Brief Summary The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Detailed Description A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose of Live Oral Cholera Vaccine Candidate, PXVX0200 CVD 103-HgR Strain, in Preventing Cholera following Challenge with Vibrio cholerae O1 El Tor Inaba 10 Days or 3 Months after Vaccination in volunteers aged 18-45 years
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cholera
Intervention  ICMJE
  • Biological: PXVX0200
    Single dose; liquid suspension after reconstitution with buffer; 5x10^8
  • Biological: placebo
Study Arms  ICMJE
  • Experimental: PXVX0200
    Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10^8 CFU
    Intervention: Biological: PXVX0200
  • Placebo Comparator: Placebo
    Biological: Placebo physiological saline
    Intervention: Biological: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2021)
197
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2013)
210
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01895855
Other Study ID Numbers  ICMJE PXVX-VC-200-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Emergent BioSolutions
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Emergent BioSolutions
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: James McCarty, MD Emergent BioSolutions
PRS Account Emergent BioSolutions
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP