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A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

Primary Purpose

Cholera

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PXVX0200 Lot A
PXVX0200 Lot B
PXVX0200 Lot C
Placebo
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholera

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Coastal Clinical Research
  • Clinical Reseach Consortium Arizona
  • Avail Clinical Research
  • Miami Research Associates
  • Palm Beach Research
  • Emory University
  • Johnson County Clin-Trials
  • Heartland Research Associates
  • Central Kentucky Research
  • University of Kentucky
  • Boston University
  • Center for Pharmaceutical Research
  • St. Louis University
  • Clinical Research Consortium Las Vegas
  • Rochester Clinical Research
  • Lion Research
  • Coastal Carolina Research
  • Research Across America
  • Jean Brown Research
  • QIMR Berghofer Medical Research Institiue
  • AUS Trials Pty Ltd
  • CMAX
  • Emeritis Research
  • Nucleus Network
  • Linear Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

PXVX0200 Lot A

PXVX0200 Lot B

PXVX0200 Lot C

Placebo

Arm Description

PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension

PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension

PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension

Placebo physiological saline

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

SVA Seroconversion at Day 11
Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable.
Adverse Events
Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever & vomiting were collected from Day 1 - 8. Incidence and severity of unsolicited adverse events were collected till Day 29.

Full Information

First Posted
March 20, 2014
Last Updated
June 26, 2023
Sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions
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1. Study Identification

Unique Protocol Identification Number
NCT02094586
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PXVX0200 Lot A
Arm Type
Experimental
Arm Description
PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Arm Title
PXVX0200 Lot B
Arm Type
Experimental
Arm Description
PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Arm Title
PXVX0200 Lot C
Arm Type
Experimental
Arm Description
PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo physiological saline
Intervention Type
Biological
Intervention Name(s)
PXVX0200 Lot A
Intervention Description
Lot P700-1CA03
Intervention Type
Biological
Intervention Name(s)
PXVX0200 Lot B
Intervention Description
Lot P700-3CA03
Intervention Type
Biological
Intervention Name(s)
PXVX0200 Lot C
Intervention Description
Lot P700-6BA03
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
Description
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.
Time Frame
Day 11
Title
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
Description
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.
Time Frame
Day 11
Title
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
Description
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.
Time Frame
Day 11
Secondary Outcome Measure Information:
Title
SVA Seroconversion at Day 11
Description
Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11
Time Frame
Day 11
Title
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Description
GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.
Time Frame
Day 1 - 181
Title
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Description
Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable.
Time Frame
Day 1 - 181
Title
Adverse Events
Description
Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever & vomiting were collected from Day 1 - 8. Incidence and severity of unsolicited adverse events were collected till Day 29.
Time Frame
Day 1 - 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James McCarty, MD
Organizational Affiliation
Emergent Travel Health Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Clinical Reseach Consortium Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Palm Beach Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Central Kentucky Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02218
Country
United States
Facility Name
Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Clinical Research Consortium Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Lion Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Coastal Carolina Research
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
QIMR Berghofer Medical Research Institiue
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
AUS Trials Pty Ltd
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4035
Country
Australia
Facility Name
CMAX
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Emeritis Research
City
Malvern East
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Nucleus Network
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29317118
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.
Results Reference
result

Learn more about this trial

A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

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