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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02094586




Registration number
NCT02094586
Ethics application status
Date submitted
20/03/2014
Date registered
24/03/2014

Titles & IDs
Public title
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
Scientific 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
Secondary ID [1] 0 0
PXVX-VC-200-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholera 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PXVX0200 Lot A
Treatment: Other - PXVX0200 Lot B
Treatment: Other - PXVX0200 Lot C
Treatment: Other - Placebo

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

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

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

Placebo comparator: Placebo - Placebo physiological saline


Treatment: Other: PXVX0200 Lot A
Lot P700-1CA03

Treatment: Other: PXVX0200 Lot B
Lot P700-3CA03

Treatment: Other: PXVX0200 Lot C
Lot P700-6BA03

Treatment: Other: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Day 11
Primary outcome [2] 0 0
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Day 11
Primary outcome [3] 0 0
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Day 11
Secondary outcome [1] 0 0
SVA Seroconversion at Day 11
Assessment method [1] 0 0
Percentage of subjects who demonstrated a =4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11
Timepoint [1] 0 0
Day 11
Secondary outcome [2] 0 0
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Assessment method [2] 0 0
GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.
Timepoint [2] 0 0
Day 1 - 181
Secondary outcome [3] 0 0
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Day 1 - 181
Secondary outcome [4] 0 0
Adverse Events
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Day 1 - 29

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
3146
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
QIMR Berghofer Medical Research Institiue - Herston
Recruitment hospital [2] 0 0
AUS Trials Pty Ltd - Sherwood
Recruitment hospital [3] 0 0
CMAX - Adelaide
Recruitment hospital [4] 0 0
Emeritis Research - Malvern East
Recruitment hospital [5] 0 0
Nucleus Network - Melbourne
Recruitment hospital [6] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
4035 - Sherwood
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bavarian Nordic
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Emergent BioSolutions
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James McCarty, MD
Address 0 0
Emergent Travel Health Inc.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M.... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02094586