Clinical trial NCT01895855: Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholera
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: Emergent BioSolutions
First posted: 2013-07-11
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: % of Participants With Moderate to Severe Diarrhea
timeFrame: Ten days after vaccination
measure: % of Participants With Moderate to Severe Diarrhea
timeFrame: Ninety days after vaccination
Secondary outcomes:
measure: Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge
timeFrame: Through 10 Days following challenge
measure: Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge
timeFrame: Through 10 Days following challenge
measure: % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge
timeFrame: Through 10 Days following challenge
measure: % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge
timeFrame: Through 10 Days following challenge
measure: % of Participants With Fever Following the 10 Day Cholera Challenge
timeFrame: Through 10 Days following challenge
measure: % of Participants With Fever Following the 90 Day Cholera Challenge
timeFrame: Through 10 Days following challenge
measure: Number of Days With Fecal Shedding Following 10 Day Challenge
timeFrame: Through 10 Days post challenge
measure: Number of Days With Fecal Shedding Following 90 Day Challenge
timeFrame: Through 10 days following challenge
measure: # of Days With Positive Stool Culture Following 10 Day Cholera Challenge
timeFrame: Through 10 Days following challenge
measure: # of Days With Positive Stool Culture Following 90 Day Cholera Challenge
timeFrame: Through 10 Days following challenge
measure: % of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination
timeFrame: Following vaccination (Days 1 - 8) and to Day 29
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Cincinnati
country: United States
facility: Cincinnati Children'S Hospital Medical Center
state: Ohio
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Emergent BioSolutions
name: James McCarty, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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 against Vibrio cholerae infection. Vaccine. 2018 May 11;36(20):2768-2773. doi: 10.1016/j.vaccine.2018.04.011. Epub 2018 Apr 11.
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 ahead of print.
citation: 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.
citation: 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.