Every GP practice in the country, and especially in Counties Manukau, will be familiar with respiratory syncytial virus (RSV). RSV is well known as a leading cause of bronchiolitis. Kidz First has the highest admission rates for infants with lower respiratory tract infections in New Zealand, with RSV identified in over 40% of cases. RSV is also the leading cause of lung disease and long-term lung morbidity world-wide.
Most children have been exposed to RSV by the age of 2 years, experiencing only mild respiratory symptoms. Younger babies, particularly those who have been born preterm or those with chronic health problems, are at greater risk of severe disease and of requiring hospital admission. However, for us in South Auckland, full-term and healthy Māori and Pacific babies are disproportionally affected. Around 5% of those admitted to Kidz First with bronchiolitis require PICU admission, and approximately one child will die each year.
Counties Manukau Health/Middlemore Clinical Trials is one of 19 centres in 6 countries taking part in a Phase III, randomised, observer-blind, placebo-controlled trial of an ante-natal RSV vaccine. The trial is aiming to test the vaccine’s effectiveness in preventing RSV disease in the babies born to vaccinated mothers. The study team are seeking pregnant women who may be interested in participating. The women need to be between 18 to 40 years-of-age, in good health, with an EDD not beyond 15th July, 2016.
Consultant Paediatrician and Principal Investigator, Dr Adrian Trenholme is encouraging GPs to refer patients from South Auckland to take part in the trial. "We have a great opportunity to make a real difference in preventing the long-term sequelae from one of the most common childhood illnesses in the world. Further, we as a medical community see the burden that respiratory illnesses place on us all over winter," he said. "If we can reduce GP visits and hospital admissions for children over the busiest period each year, we all benefit."
This is year one of the four year trial which is aiming to recruit 8,000 women, with 300-400 coming from two New Zealand sites, Counties Manukau and Christchurch. In the earlier Phase I and II studies of the vaccine that focused on the safety profile and immunogenicity of the vaccine, over 1000 subjects in the USA were vaccinated, the majority of which were women of child-bearing age. Results showed that the vaccine was well-tolerated, with no serious adverse effects. Fifty pregnant women have also been vaccinated in an a Phase II study, and results up to day 60 post delivery show no adverse events related to the vaccine in either the infants or mothers.
The current trial protocol stipulates autumn vaccination of expectant mothers in order to test the protection of babies over the winter when RSV disease is at its most prevalent. The team at Middlemore Clinical trials will screen and vaccinate eligible mothers up until the 13th May 2016, and will follow up the babies until they are at least 1 year of age.
Please encourage your expectant mothers to consider taking part in this important trial. The results of this study have the potential to positively affect our local population. Call 0800 RSV BABY or 0800 778 2229 for more information, or to refer an interested expectant mother.