Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001881114 Date of Approval: 21/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sun protection to improve vaccine effectiveness
Official scientific title Sun protection to improve vaccine effectiveness in children in a high ambient ultraviolet radiation and rural environment: an intervention study
Brief summary describing the background and objectives of the trial Background: Vaccination is a mainstay of preventive healthcare, reducing the incidence of serious childhood infections. Ecological studies have demonstrated an inverse association between markers of high ambient ultraviolet (UV) radiation exposure (e.g. sunny season, low latitude of residence) and reduction in the vaccination-associated immune response. Higher sun exposure on the day prior to and spanning the day of vaccination has been associated with a reduced antigen-specific immune response independent of skin pigmentation. The South African Department of Health¿s Expanded Programme on Immunisation provides free vaccinations in government primary health care clinics. In some areas, these clinics may have only a small waiting room and patients wait outside in full sun conditions. In rural areas, patients may walk several kilometres to and from the clinic. We hypothesised that providing sun protection advice and equipment to mothers of children (from 18 months) who were waiting to be vaccinated would result in a more robust immune response for those vaccinated. Methods: We conducted an intervention study among 100 children receiving the booster measles vaccination. We randomised clinics to receive (or not) sun protection advice and equipment. At each clinic we recorded basic demographic data on the child and mother/carer participants, their sun exposure patterns, and the acceptability and uptake of the provided sun protection. At 3-4 weeks post-vaccination, we measured measles IgG levels in all children. Discussion: This is the first intervention study to assess the effect of sun protection measures on vaccine effectiveness in a rural, real-world setting. The novel design and rural setting of the study can contribute much needed evidence to better understand sun exposure and protection, as well as factors determining vaccine effectiveness in rural Africa, and inform the design of immunisation programmes.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Immune response
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 04/01/2016
Actual trial start date 18/01/2016
Anticipated date of last follow up 25/03/2016
Actual Last follow-up date 29/04/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
SAMRC EC013-4/2015; DOH-27-1116-5591
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Participants visiting the intervention or control clinics were included if they met the study criteria Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sun protection Sun protection daily for one week Wear hat, clothing, umbrella 50
Control Group Standard care once once Booster measles vaccination 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study population included children aged 18 months or older, presenting at the selected clinics for their second measles vaccination. Eligibility criteria included that the child had received the first measles vaccine, their mother or guardian was deemed able to comprehend the research and complete the sun exposure diary, and was capable of signing consent for the child to be enrolled in the study, the mother had a copy of the child¿s Road to Health Chart, and the mother confirmed that they would be available for the duration of the study (4 weeks). Younger than 18 months Didn't have first measles vaccine 18 Month(s) 20 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/04/2015 SAMRC
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive Cape Town 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome IgG antibody levels 3-4 weeks post measles vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hlaneki Clinic Ext 4 Giyani South Africa
Thomo Clinic Ext 3 Giyani South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NRF Meiring Naude Drive Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NRF Meiring Naude Drive Pretoria 0001 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Robyn Lucas Australia National University Canberra Australia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caradee Wright cwright@mrc.ac.za 27826774037 1 Soutpansberg Road
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Specialist Scientist
Role Name Email Phone Street address
Public Enquiries Aziel Gangerdine Aziel.Gangerdine@mrc.ac.za 27219380687 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Media Manager
Role Name Email Phone Street address
Scientific Enquiries Caradee Wright cwright@mrc.ac.za 27123398543 1 Soutpansberg Road
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Specialist Scientist
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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