RSV Vaccine in Pregnancy

Project Plan

Infectious diseases are still the most common cause of death in children and the most common reason that children under two years of age are admitted to hospital. Worldwide, 10 million children under the age of five die from infection each year.

RSV is the leading cause of lung disease in infants and children less than five years of age (worldwide). By the age of two, almost everyone has been exposed to RSV. Some experts believe that RSV illness early in life can also increase the chances of a child developing wheezing and asthma when they are older.

Globally, there are about 30 million new cases of RSV disease in children under the age of five reported each year and up to 200,000 of these children may die. Australia wide RSV accounts for 25% of all admissions to hospital in children under 6 months. There is currently no vaccine to prevent it, or medication available to treat it. Antibiotics cannot be used to fight viruses like RSV.

RSV, or Respiratory Syncytial (pronounced sin-sish-(e)-el) Virus, is a virus that infects the airways and lungs. RSV is similar to the viruses that cause the flu or the common cold. The virus causes symptoms such as runny nose, cough and trouble breathing, and is extremely common. Almost every infant is exposed to RSV by the age of 2. Many children experience mild symptoms that are mistaken for the common cold and get better without treatment. Newborn babies 0-6 months of age can develop more severe complications such as bronchiolitis (inflammation of the small airways in the lungs) or pneumonia and may require hospitalisation due to the infant not being able to feed or requiring oxygen.

The Maternal RSV Vaccine Study aims to determine whether an RSV vaccine given to pregnant women during the third trimester can protect newborn babies from RSV infections. Similar clinical studies have given investigational vaccines to pregnant women and have been proven to protect newborn babies against tetanus, pertussis (whooping cough) and influenza. To help determine if the vaccine is effective against RSV some pregnant women will receive the RSV vaccine and others will receive a placebo vaccine.

The Vaccine Trials Group, based at the Telethon Kids Institute, is staffed by a dedicated team of doctors, nurses, researchers, scientists, PhD, Honours and Masters students, phlebotomists and administration staff. With infectious diseases still the most common cause of death in children, we are evaluating new vaccines for a range of diseases including influenza, pneumococcal, meningococcal and common infections such as otitis media (glue ear).

The Vaccine Trials group run the study in Perth by collecting demographic data, obtaining medical and obstetric history, checking on general health, collecting medication usage, performing physical examinations, giving vaccines and taking blood, throat and nose samples. This ensures that accurate, robust data is collected and follows ICH GCP standards. If a maternal vaccine to prevent serious RSV disease in infants is found to be effective, this will have significant impact on global infant morbidity and mortality.

Your Support

The study will last until your baby is 12 months of age. In total, three or four antenatal and eight postnatal visits to the study clinic, located at Princess Margaret Hospital and Perth Children’s Hospital. At the start of the study you will be randomly assigned to receive 1 injection of either the RSV or placebo. Two out of every three women will receive the RSV vaccine. Five blood tests for you and two blood tests for your baby to follow-up the immune response to the vaccine. During the study, swabs will be taken for cold-like illness symptoms from you and your baby.

Face to face consent is required once the participant has read and fully understands the Participant Information Statement and Consent Form. This must be signed in front of and witnessed by a Medical Doctor. A copy will be given for personal records.

During study appointments approx. once per month until 6 months of age, the baby will be examined and checked for general health and development by a Medical Doctor and Nurse. All study exams and procedures are provided free of charge. Reimbursement will be given for travel costs.

 

If you’re interested in learning more or in participating in this study please contact the research team directly:


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Project Members

Peter Richmond
Principal Investigator

Head of Vaccine Trials Group

Tanya Stoney
Medical Doctor

Clinical Research Fellow

Rachel West
Study Coordinator

Clinical Research Coordinator

Fiona McDonald
Research Nurse
Kate Britton
Research Nurse