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Trial registered on ANZCTR


Registration number
ACTRN12609000380291
Ethics application status
Approved
Date submitted
5/04/2009
Date registered
28/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing in young Australian adults whether exposure to simulated solar ultraviolet radiation affects immune response to primary vaccination.
Scientific title
Assessing in healthy young Australian fair-skinned adults whether exposure to simulated solar ultraviolet radiation (UVR) affects immune response to primary vaccination.
Universal Trial Number (UTN)
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-dependent antigen (Keyhole Limpet Haemocyanin) 4567 0
Condition category
Condition code
Inflammatory and Immune System 4860 4860 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive 0.8 x minimal erythemal dose of simulated solar UVR daily for five days (via a calibrated UVR lamp) delivered to a 5x5cm area of skin over the lower thigh. On the day following the last dose of UVR, participants will be vaccinated with 125mcg of Keyhole Limpet Haemocyanin (KLH) with Montanide-ISA 51 adjuvant subcutaneously to the site of irradiation.
Intervention code [1] 4330 0
Other interventions
Comparator / control treatment
The control group will undertake sun protection measures for 5 days. This involves use of broad spectrum sun screen and protective clothing when outside. On the day following the last day of UVR avoidance, participants will be vaccinated with 125mcg of Keyhole Limpet Haemocyanin (KLH) with Montanide-ISA 51 adjuvant subcutaneously to the lower thigh.
Control group
Active

Outcomes
Primary outcome [1] 5714 0
Humoral response to primary subcutaneous vaccination with Keyhole Limpet Haemocyanin (KLH). KLH-specific immunoglobulins (Ig) (Ig types M, E, G and subsets) will be quantified via enzyme linked immunoassay techniques.
Timepoint [1] 5714 0
KLH specific antibody titres taken at baseline (immediately prior to vaccination which follows the 5 days of UVR irradiation or sun avoidance); 1 week and 3 weeks post vaccination
Primary outcome [2] 5715 0
Delayed-type hypersensitivity (DTH) response to intra-dermal KLH will be measured in millimetres of skin reaction.
Timepoint [2] 5715 0
Intradermal KLH given at day 21 post vaccination. DTH response read at 48 hours post intradermal KLH.
Secondary outcome [1] 241633 0
KLH specific T-cell response will be measured via lymphocyte proliferation assays.
Timepoint [1] 241633 0
Measured at baseline (immediately prior to vaccination) and day 21.

Eligibility
Key inclusion criteria
* Age 18 - 40 years
* Fitzpatrick Type II-III skin (fair skin which sunburns without difficulty)
* 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 of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will occur via computer generated randomisation. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5043 0
Self funded/Unfunded
Name [1] 5043 0
Country [1] 5043 0
Primary sponsor type
Individual
Name
Dr Ashwin Swaminathan
Address
National Centre for Epidemiology and Population Health,
Building 62
Australian National University
Canberra
Australian Capital Territory 0200
Country
Australia
Secondary sponsor category [1] 4294 0
None
Name [1] 4294 0
Address [1] 4294 0
Country [1] 4294 0
Other collaborator category [1] 630 0
Individual
Name [1] 630 0
Dr Robyn Lucas
Address [1] 630 0
National Centre for Epidemiology and Population Health,
Building 62
Australian National University
Canberra
Australian Capital Territory 0200
Country [1] 630 0
Australia
Other collaborator category [2] 631 0
Individual
Name [2] 631 0
Assoc/Prof Michael Kimlin
Address [2] 631 0
Australian Sun and Health Research Laboratory
O Block, D wing
Victoria Park Road,
Kelvin Grove QLD, 4059, Australia
Queensland University of Technology
Country [2] 631 0
Australia
Other collaborator category [3] 632 0
Individual
Name [3] 632 0
Professor Tony McMichael
Address [3] 632 0
National Centre for Epidemiology and Population Health,
Building 62
Australian National University
Canberra Australian Capital Territory 0200
Country [3] 632 0
Australia
Other collaborator category [4] 633 0
Individual
Name [4] 633 0
Dr Matthew Cook
Address [4] 633 0
Immunology Department
Canberra Hospital
Yamba Drive
Garran Canberra
Australian Capital Territory 2605
Country [4] 633 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239133 0
Human Research Ethics Committee, Australian National University
Ethics committee address [1] 239133 0
Ethics committee country [1] 239133 0
Australia
Date submitted for ethics approval [1] 239133 0
11/03/2009
Approval date [1] 239133 0
03/04/2009
Ethics approval number [1] 239133 0
2009/031

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29467 0
Address 29467 0
Country 29467 0
Phone 29467 0
Fax 29467 0
Email 29467 0
Contact person for public queries
Name 12714 0
Ashwin Swaminathan
Address 12714 0
National Centre for Epidemiology and Population Health
Building 62
Australian National University
Canberra
Australian Capital Territory 0200
Country 12714 0
Australia
Phone 12714 0
+61 (0)2 6125 2378
Fax 12714 0
Email 12714 0
[email protected]
Contact person for scientific queries
Name 3642 0
Ashwin Swaminathan
Address 3642 0
National Centre for Epidemiology and Population Health
Building 62
Australian National University
Canberra
Australian Capital Territory 0200
Country 3642 0
Australia
Phone 3642 0
+61 (0)2 6125 2378
Fax 3642 0
Email 3642 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

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

Documents added automatically
No additional documents have been identified.