A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
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
1 other identifier
interventional
3,146
2 countries
25
Brief Summary
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2014
Shorter than P25 for phase_3
25 active sites
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
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
July 15, 2021
CompletedJune 28, 2023
June 1, 2023
9 months
March 20, 2014
July 3, 2018
June 26, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.
Day 11
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Day 11
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Day 11
Secondary Outcomes (4)
SVA Seroconversion at Day 11
Day 11
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Day 1 - 181
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Day 1 - 181
Adverse Events
Day 1 - 29
Study Arms (4)
PXVX0200 Lot A
EXPERIMENTALPXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
PXVX0200 Lot B
EXPERIMENTALPXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
PXVX0200 Lot C
EXPERIMENTALPXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
Placebo
PLACEBO COMPARATORPlacebo physiological saline
Interventions
Eligibility Criteria
You may qualify if:
- healthy men or women,
- age 18 to 45 years inclusive;
- normal medical history and physical examination
- 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;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bavarian Nordiclead
- Emergent BioSolutionscollaborator
Study Sites (25)
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Clinical Reseach Consortium Arizona
Phoenix, Arizona, 85004, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Miami Research Associates
Miami, Florida, 33143, United States
Palm Beach Research
West Palm Beach, Florida, 33409, United States
Emory University
Atlanta, Georgia, 30322, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Central Kentucky Research
Lexington, Kentucky, 40509, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Boston University
Boston, Massachusetts, 02218, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
St. Louis University
St Louis, Missouri, 63104, United States
Clinical Research Consortium Las Vegas
Las Vegas, Nevada, 89119, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Lion Research
Norman, Oklahoma, 73069, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464, United States
Research Across America
Dallas, Texas, 75234, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
QIMR Berghofer Medical Research Institiue
Herston, Queensland, 4006, Australia
AUS Trials Pty Ltd
Sherwood, Queensland, 4035, Australia
CMAX
Adelaide, South Australia, 5000, Australia
Emeritis Research
Malvern East, Victoria, 3145, Australia
Nucleus Network
Melbourne, Victoria, 3004, Australia
Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
Related Publications (1)
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.
PMID: 29317118RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Cassie, Scientist, Clinical Research
- Organization
- Emergent BioSolutions Canada Inc.
Study Officials
- STUDY DIRECTOR
James McCarty, MD
Emergent Travel Health Inc.
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
March 20, 2014
First Posted
March 24, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2015
Study Completion
June 1, 2015
Last Updated
June 28, 2023
Results First Posted
July 15, 2021
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share