Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000234011
Ethics application status
Approved
Date submitted
17/03/2010
Date registered
19/03/2010
Date last updated
5/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian Ultraviolet Radiation and Immunity Study
Scientific title
Assessing in healthy young Australian adults whether exposure to solar ultraviolet radiation (UVR) at levels relevant to normal daily activities affects immune response to primary vaccination.
Universal Trial Number (UTN)
U1111-1114-4701
Trial acronym
AusUVI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impact of solar ultraviolet radiation on human primary immune response to immunisation with a T-cell dependent antigen (Keyhole Limpet Hemocyanin or KLH) 256986 0
Condition category
Condition code
Inflammatory and Immune System 257137 257137 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will wear a ultraviolet radiation (UVR) absorbant wrist band which will measure UVR personal exposure for 5 days. Subsequently all participants will be vaccinated subcutaneously with 125mcg keyhole limpet hemocyanin (KLH) administered to a sun exposed part of the forearm. Participants will be recruited over a 52 week period.
Intervention code [1] 256161 0
Not applicable
Comparator / control treatment
We are correlating UVR exposure against immune response to vaccination. There is not control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258033 0
Humoral response to primary subcutaneous vaccination with Keyhole Limpet Hemocyanin (KLH). KLH-specific immunoglobulins (Ig) (Ig types M, E, G and subsets) will be quantified via enzyme linked immunoassay techniques.
Timepoint [1] 258033 0
KLH specific antibody titres taken at baseline (immediately prior to vaccination which follows the 5 days of UVR exposure measurement); 1 week and 3 weeks post vaccination
Secondary outcome [1] 263599 0
Delayed-type hypersensitivity (DTH) response to intra-dermal KLH will be measured in millimetres of skin reaction
Timepoint [1] 263599 0
Intradermal KLH given at day 21 post vaccination. DTH response read at 48 hours post intradermal KLH.
Secondary outcome [2] 263600 0
KLH specific T-cell response will be measured via lymphocyte proliferation assays and cytokine production.
Timepoint [2] 263600 0
Measured at baseline (immediately prior to vaccination) and day 21.

Eligibility
Key inclusion criteria
* Age 18 - 40 years
* Healthy
* Willing and able to sign informed consent
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Allergy to shellfish
* Pregnancy or breastfeeding
* Previous KLH vaccination
* Immunosuppressive medications
* Immunosuppressive medical condition
* Recent infection (within 2 weeks of vaccination)
* Recent immunisation with any other vaccine in past 4 weeks
* Photosensitive skin or taking photosensitsing medication

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2628 0
0200
Recruitment postcode(s) [2] 2629 0
2605
Recruitment postcode(s) [3] 2630 0
4814
Recruitment postcode(s) [4] 2631 0
4811

Funding & Sponsors
Funding source category [1] 256662 0
Government body
Name [1] 256662 0
National Research and Medical Research Council
Country [1] 256662 0
Australia
Primary sponsor type
Individual
Name
Dr Robyn Lucas
Address
National Centre for Epidemiology and Population Health
Building 62
Australian National University
Canberra
Australian Capital Territory 0200
Country
Australia
Secondary sponsor category [1] 255951 0
Individual
Name [1] 255951 0
Dr Ashwin Swaminathan
Address [1] 255951 0
National Centre for Epidemiology and Population Health
Building 62
Australian National University
Canberra
Australian Capital Territory 0200
Country [1] 255951 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258684 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 258684 0
Research Office
Level 3
Innovations Building (124)
Corner Eggleston and Garran Roads
Australian National University
Acton Australian capital Territory
0200
Ethics committee country [1] 258684 0
Australia
Date submitted for ethics approval [1] 258684 0
13/01/2010
Approval date [1] 258684 0
04/02/2010
Ethics approval number [1] 258684 0
2009/628

Summary
Brief summary
This study assesses whether exposure to solar ultraviolet radiation at levels relevant to normal daily activities can suppress the immune response to vaccination in young, healthy adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30637 0
Address 30637 0
Country 30637 0
Phone 30637 0
Fax 30637 0
Email 30637 0
Contact person for public queries
Name 13884 0
Dr Ashwin Swaminathan
Address 13884 0
National Centre for Epidemiology and Population Health
Building 62
Australian National University
Canberra
Australian Capital Territory
0200
Country 13884 0
Australia
Phone 13884 0
+61 2 61252378
Fax 13884 0
+61 2 6125 0740
Email 13884 0
[email protected]
Contact person for scientific queries
Name 4812 0
Ashwin Swaminathan
Address 4812 0
National Centre for Epidemiology and Population Health
Building 62
Australian National University
Canberra
Australian Capital Territory
0200
Country 4812 0
Australia
Phone 4812 0
+61 2 6125 2378
Fax 4812 0
+61 2 6125 0740
Email 4812 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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