Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country
Australia
Secondary sponsor category [1] 255951 0
Individual
Name [1] 255951 0
Dr Ashwin Swaminathan
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
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
Trial website
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
ashwin.swaminathan@anu.edu.au
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
ashwin.swaminathan@anu.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.