Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000233325
Ethics application status
Approved
Date submitted
10/02/2017
Date registered
14/02/2017
Date last updated
7/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational longitudinal pilot study to assess pharyngeal carriage of Neisseria meningitidis in South Australian university students.
Scientific title
An observational longitudinal pilot study to assess pharyngeal carriage of Neisseria meningitidis in South Australian university students.
Secondary ID [1] 291146 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Meningococcal disease 301996 0
Neisseria meningitides pharyngeal carriage 301997 0
Condition category
Condition code
Infection 301637 301637 0 0
Studies of infection and infectious agents
Public Health 301638 301638 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An oropharyngeal swab will be collected from South Australian first year university students during orientation week in 2017 and repeated 3 months later.

PorA nucleic acid testing (NAT) for Neisseria species will be conducted on each pharyngeal swab and used to estimate the carriage prevalence of all serogroups of N. meningitidis.
Intervention code [1] 297128 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301046 0
Estimate the carriage prevalence of all serogroups of N. meningitidis in South Australian first year university students.

PCR screening for the presence of specific N. meningitidis DNA (using PorA) will be conducted on all oropharyngeal swabs. Further molecular analysis will be used to determine which serogroup has been detected (A,B,C,W,Y).
Timepoint [1] 301046 0
Visit one during orientation week (20th to 24th of February 2017) and visit two 3 months later.
Secondary outcome [1] 331553 0
Estimate the measure of agreement between N. meningitidis PCR positive oropharyngeal samples frozen at 6, 16, and 48 hours post collection.

Aliquots from each N. meningitidis PCR positive sample will be frozen at different time intervals (6, 16, 48 hours) to compare the detection of specific meningococcal DNA (using PorA) on each sample following freezing and thawing.
Timepoint [1] 331553 0
During orientation week (20th to 24th of February 2017).
Secondary outcome [2] 331556 0
Estimate the change in carriage prevalence of all serogroups of N. meningitidis in South Australian first year university students from the start of university to 3 months later.

PCR screening for the presence of specific N. meningitidis DNA (using PorA) will be conducted on all oropharyngeal swabs at visit one (orientation week) and visit two 3 months later. Further molecular analysis will be used to determine which serogroup has been detected (A,B,C,W,Y).
Timepoint [2] 331556 0
Visit one during orientation week (20th to 24th of February 2017) and visit two 3 months later.
Secondary outcome [3] 331659 0
Estimate the difference in N. meningitidis carriage density by conducting quantitative PCR testing (qPCR) of oropharyngeal samples frozen at 6, 16, and 48 hours post collection.

Aliquots from each N. meningitidis positive sample will be frozen at different time intervals (6, 16, 48 hours) to compare growth of Neisseria species. Quantitative PCR will be applied for estimation of the density of carriage of the Neisseria species.
Timepoint [3] 331659 0
During orientation week (20th to 24th of February 2017)
Secondary outcome [4] 331669 0
Estimate the difference between N. meningitidis culture positive samples frozen at 6, 16, and 48 hours post collection.

Aliquots from each N. meningitidis PCR positive sample will be frozen at different time intervals (6, 16, 48 hours) to compare growth of Neisseria species. Skim milk tryptone glucose glycerol (STGG) broth is to be streaked on Neisseria selective agar (GC agar) only and incubated overnight in CO2 at 35 o C. Plates are to be read at day 2 and day 4 specifically for Neisseria species and final report at day 4.
Timepoint [4] 331669 0
During orientation week (20th to 24th of February 2017)
Secondary outcome [5] 346542 0
Identify characteristics associated with carriage prevalence of all N. meningitidis genogroups in South Australian first year university students.
Timepoint [5] 346542 0
Baseline swabs

Eligibility
Key inclusion criteria
South Australian first year university students between 17 to 25 years of age.
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary endpoint of all serogroups is dichotomous and classified as either carriage, or no pharyngeal carriage of N. meningitidis. Descriptive statistics will report percentages, means with standard deviations, median, and/or range (as appropriate) Categorical outcomes will be described using odds ratios with 95% confidence intervals. Cohen's Kappa statistic will be used to measure agreement between different laboratory freezing times and PCR positive tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2017
Actual
20/02/2017
Date of last participant enrolment
Anticipated
24/02/2017
Actual
24/02/2017
Date of last data collection
Anticipated
30/06/2017
Actual
28/08/2017
Sample size
Target
500
Accrual to date
Final
421
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 295583 0
Commercial sector/Industry
Name [1] 295583 0
GlaxoSmithKline Biologicals S.A.
Country [1] 295583 0
Belgium
Primary sponsor type
University
Name
The University of Adelaide
Address
Robinson Research Institute and Adelaide Medical School
Discipline of Paediatrics
Women's & Children's Hospital
Level 2 Clarence Reiger Building
72 King William Road
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 294418 0
None
Name [1] 294418 0
None
Address [1] 294418 0
None
Country [1] 294418 0
Other collaborator category [1] 279422 0
Government body
Name [1] 279422 0
SA Health
Address [1] 279422 0
Citi Centre
11 Hindmarsh Square
Adelaide SA 5000
Country [1] 279422 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296905 0
Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC)
Ethics committee address [1] 296905 0
Research Secretariat
Women's and Children's Health Network
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 296905 0
Australia
Date submitted for ethics approval [1] 296905 0
25/08/2016
Approval date [1] 296905 0
02/11/2016
Ethics approval number [1] 296905 0
HREC/16/WCHN/140

Summary
Brief summary
Our pilot study will establish baseline carriage prevalence in approximately 500 first year university students. The findings will assist in a more refined estimation of sample size required for a cross sectional study of first year university students to be conducted in 2018 and 2019. It will also be used to validate study processes including delayed freezing of samples.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72390 0
Prof Helen Marshall
Address 72390 0
Vaccinology & Immunology Research Trials Unit
Women's and Children's Hospital
Level 2 Clarence Reiger Building
72 King William Road
North Adelaide SA 5006
Country 72390 0
Australia
Phone 72390 0
+ 61 (0)8 8161 8115
Fax 72390 0
Email 72390 0
[email protected]
Contact person for public queries
Name 72391 0
Ms Su-San Lee
Address 72391 0
Vaccinology & Immunology Research Trials Unit
Women's and Children's Hospital
Level 2 Clarence Reiger Building
72 King William Road
North Adelaide SA 5006
Country 72391 0
Australia
Phone 72391 0
+61 (0)8 8161 8117
Fax 72391 0
Email 72391 0
[email protected]
Contact person for scientific queries
Name 72392 0
Prof Helen Marshall
Address 72392 0
Vaccinology & Immunology Research Trials Unit
Women's and Children's Hospital
Level 2 Clarence Reiger Building
72 King William Road
North Adelaide SA 5006
Country 72392 0
Australia
Phone 72392 0
+ 61 (0)8 8161 8115
Fax 72392 0
Email 72392 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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