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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02100631
Registration number
NCT02100631
Ethics application status
Date submitted
25/03/2014
Date registered
1/04/2014
Date last updated
28/06/2023
Titles & IDs
Public title
A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults
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Scientific title
A Phase III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 O1 Serotype Inaba Strain CVD 103-HgR
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Secondary ID [1]
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PXVX-VC-200-005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cholera
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - PXVX0200
Other interventions - Placebo
Experimental: PXVX0200 in Older Adults - PXVX0200 Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Placebo Comparator: Placebo in Older Adults - Placebo physiological saline
Other: Historical Control: Adults Aged 18-45 - This arm consists of historical data from subjects who received a single dose of PXVX0200 in study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
Other interventions: PXVX0200
Other interventions: Placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Seroconversion Rate at Day 11
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Assessment method [1]
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The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
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Timepoint [1]
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Day 11
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Secondary outcome [1]
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Geometric Mean Titer (GMT)
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Assessment method [1]
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The Day 11 vibriocidal GMTs were compared between older and younger adults.
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Timepoint [1]
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Day 11
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Eligibility
Key inclusion criteria
1. Able to understand the study and give written consent.
2. Healthy male and female adults, age 46-64 years (inclusive) without significant
medical history, physical, or abnormal screening laboratory test results at screening.
3. Women of childbearing potential must have had a negative urine pregnancy test at
screening, prior to vaccination. Female subjects must be of non-childbearing potential
(as defined as surgically sterile or postmenopausal for more than 1 year), or if of
childbearing potential must be practicing abstinence or using an effective licensed
method of birth control (eg, use hormonal or barrier birth control such as implants,
injectables, combined oral contraceptives, intrauterine devices [IUDs], cervical
sponges, diaphragms, condoms with spermicidal agents; or must have a vasectomized
partner) within 2 months of vaccination and must agree to continue such precautions
during the study.
4. Willing and able to comply with the study requirements and procedures.
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Minimum age
46
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Currently active unstable or undiagnosed medical conditions including
immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder,
liver disease, renal disease, gastrointestinal disease, neurologic illness,
psychiatric disorder requiring hospitalization, current drug or alcohol abuse.
Examples of unstable or undiagnosed medical conditions including unstable angina
pectoris, shortness of breath on exertion without clear etiology and chronic renal
failure requiring dialysis. Examples of conditions that do not meet exclusion criteria
include mild controlled hypertension, mild controlled asthma, and treated depression
without hospitalization.
2. Abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools
per day in past 6 months.
3. Regular use of laxatives in the past 6 months.
4. Previously received a licensed or investigational cholera vaccine.
5. History of cholera or enterotoxigenic E. coli infection (natural infection or
experimental challenge).
6. Travel to a cholera-endemic area in the previous 5 years.
7. Received or plans to receive any other licensed vaccines, except for seasonal
influenza vaccine, from 14 days prior to the study vaccination through to 29 days
after vaccination.
8. Received or plans to receive antibiotics or chloroquine within 14 days prior to the
study vaccination through to 29 days after vaccination.
9. Recipient of bone marrow or solid organ transplant.
10. Use of systemic chemotherapy in the previous 5 years prior to the study.
11. Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders
diagnosed or treated during the past 5 years.
12. Received or plans to receive systemic immunosuppressive therapy, radiation therapy,
parenteral or high-dosage inhaled steroids (>800 µg/day of beclomethasone
diproprionate or equivalent) within 6 months prior to the study vaccination through to
Day 29.
13. History of Guillain-Barré Syndrome.
14. Pregnant or nursing.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2015
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Sample size
Target
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Accrual to date
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Final
398
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Alabama
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Florida
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United States of America
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Georgia
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United States of America
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Kansas
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United States of America
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Kentucky
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Massachusetts
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Missouri
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South Carolina
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Texas
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Utah
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United States of America
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State/province [11]
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Vermont
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bavarian Nordic
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Emergent BioSolutions
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Demonstrate that the vaccine offers protection based on antibody levels in older adults and
is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02100631
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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James McCarty, MD
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Address
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Emergent Travel Health Inc.
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02100631
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