Clinical trial NCT02094586: A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
Official title: Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholera
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: Emergent BioSolutions
First posted: 2014-03-24
Enrollment: 3146
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 primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

Detailed description: The primary goal of this Phase III study is to compare three lots for consistency of manufacture.

Eligibility criteria: Inclusion Criteria:

* healthy men or women,
* age 18 to 45 years inclusive;
* normal medical history and physical examination
* 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;
* Currently active unstable or undiagnosed medical conditions
* current or recent antibiotic use;
* pregnancy or nursing;
* Previously received a licensed or investigational cholera vaccine
* History of cholera or enterotoxigenic E. coli infection
* History of Guillain-Barré Syndrome
* Received or plans to receive any other licensed vaccines, except for seasonal influenza
* Recipient of bone marrow or solid organ transplant
* Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
* Use of systemic chemotherapy in the previous 5 years prior to the study
* any immunosuppressive medical condition

Primary outcomes:
measure: Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
timeFrame: Day 11
measure: Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
timeFrame: Day 11
measure: Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
timeFrame: Day 11
Secondary outcomes:
measure: SVA Seroconversion at Day 11
timeFrame: Day 11
measure: SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
timeFrame: Day 1 - 181
measure: SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
timeFrame: Day 1 - 181
measure: Adverse Events
timeFrame: Day 1 - 29
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Clinical Reseach Consortium Arizona
state: Arizona
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Consortium Las Vegas
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Norman
country: United States
facility: Lion Research
state: Oklahoma
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research
state: South Carolina
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Herston
country: Australia
facility: QIMR Berghofer Medical Research Institiue
state: Queensland
city: Sherwood
country: Australia
facility: AUS Trials Pty Ltd
state: Queensland
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
city: Malvern East
country: Australia
facility: Emeritis Research
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: Emergent Travel Health Inc.
name: James McCarty, MD
role: STUDY_DIRECTOR
References:
citation: McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018 Feb 1;36(6):833-840. doi: 10.1016/j.vaccine.2017.12.062. Epub 2018 Jan 6.