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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02100631




Registration number
NCT02100631
Ethics application status
Date submitted
25/03/2014
Date registered
1/04/2014

Titles & IDs
Public title
A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults
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
Secondary ID [1] 0 0
PXVX-VC-200-005
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
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vehicle Lotion

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


Treatment: Drugs: Vehicle Lotion
control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Seroconversion Rate at Day 11
Timepoint [1] 0 0
Day 11
Primary outcome [2] 0 0
Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
Timepoint [2] 0 0
14 days
Secondary outcome [1] 0 0
Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit
Timepoint [1] 0 0
12 months post-procedure
Secondary outcome [2] 0 0
Geometric Mean Titer (GMT)
Timepoint [2] 0 0
Day 11
Secondary outcome [3] 0 0
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
Timepoint [3] 0 0
12 months post-procedure
Secondary outcome [4] 0 0
Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
Timepoint [4] 0 0
12 months post-procedure
Secondary outcome [5] 0 0
Incidence of Subjects Achieving a = 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
Timepoint [5] 0 0
12 months post-procedure

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.
Minimum age
46 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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
398
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
National Head Lice Treatment Centre - Ringwood East
Recruitment postcode(s) [1] 0 0
3135 - Ringwood East
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Vermont
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Prague
Country [13] 0 0
Italy
State/province [13] 0 0
Bari
Country [14] 0 0
New Zealand
State/province [14] 0 0
Auckland
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bavarian Nordic
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Emergent BioSolutions
Address [1] 0 0
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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, Bennett S, Hunt KM, Simon JK,... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02100631