Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

Cholera Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895855
• Other study ID #: PXVX-VC-200-003
• Status: Completed
• Phase: Phase 3
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: June 2023
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholera

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	University of Vermont	Burlington	Vermont
United States	Cincinnati Children'S Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Bavarian Nordic	Emergent BioSolutions

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 I — View Citation

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 agains — View Citation

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 ahe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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
Primary	% 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	Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge	Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 10 day cholera challenge.	Through 10 Days following challenge
Secondary	Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge	Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 90 day cholera challenge.	Through 10 Days following challenge
Secondary	% of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge	Incidence of mild or worse (any severity) diarrhea following the 10 day cholera challenge.	Through 10 Days following challenge
Secondary	% of Participants With Diarrhea of Any Severity Following a 90 Day Challenge	Incidence of mild or worse (any severity) diarrhea following the 90 day cholera challenge.	Through 10 Days following challenge
Secondary	% of Participants With Fever Following the 10 Day Cholera Challenge	Incidence of mild or worse fever following the 10 day cholera challenge.	Through 10 Days following challenge
Secondary	% of Participants With Fever Following the 90 Day Cholera Challenge	Incidence of mild or worse fever following the 90 day cholera challenge.	Through 10 Days following challenge
Secondary	Number of Days With Fecal Shedding Following 10 Day Challenge	Number of days of fecal shedding of wild type V. cholerae following 10 Day Challenge.	Through 10 Days post challenge
Secondary	Number of Days With Fecal Shedding Following 90 Day Challenge	Number of days of fecal shedding of wild type V. cholerae following 90 Day Challenge	Through 10 days following challenge
Secondary	# of Days With Positive Stool Culture Following 10 Day Cholera Challenge	Total number of days with a positive stool culture following the 10 Day Cholera challenge.	Through 10 Days following challenge
Secondary	# of Days With Positive Stool Culture Following 90 Day Cholera Challenge	Total number of days with a positive stool culture following 90 Day Cholera Challenge	Through 10 Days following challenge
Secondary	% of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination	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).	Following vaccination (Days 1 - 8) and to Day 29